ADVANCED BREAST CANCER TRIALS

Trials currently recruiting (open to new patients) or pending for patients diagnosed with Stage 3 (locally recurrent), or Stage 4 (metastatic) invasive breast cancer.

We’ve made every effort to ensure this information is accurate, but you’ll need to talk to your doctor or contact the trial coordinator to find out more about whether a trial is suitable for you. Are we out of date? If you have updated or new information about a trial, we’d be grateful if you’d share it with us – email your update to ClinicalTrials@nzbcf.org.nz

The trials below are available in selected New Zealand hospitals – if you think you might be a candidate for a particular trial, use the contact details supplied, or talk to your doctor. Want to access a trial that’s not in your area? It’s not always possible, but to find out more about how to access a trial and how to discuss it with your doctor, see the Quick Links above.

  • HER2+

     

  • Triple negative

     

  • Er+

     

  • Other

     

  • REGISTER YOUR INTEREST

    Tell us if you’re interested in joining a clinical trial.
    We’ll keep searching for new studies
    ClinicalTrials@nzbcf.org.nz

  • ARX-788 (Recruiting)
    A dose-escalation study of ARX788, administered by IV in subjects with HER2 positive metastatic breast cancer

     

     

     

  • KEYNOTE-086 (Recruiting)
    Pembrolizumab (Keytruda) for metastatic triple-negative breast cancer (MK-3475-086/)

    KEYNOTE-119 (Recruiting)
    Pembrolizumab (Keytruda) for metastatic triple-negative breast cancer (MK-3475-086/)

     

     

     

  • ELIMINATE (Recruiting)
    Neoadjuvant chemotherapy +/- concurrent aromatase inhibitor endocrine therapy to down-stage large ER+ breast cancer (including locally advanced stage 3, but not metastatic stage 4)

     

     

  • No trials currently recruiting or pending in NZ

     

     

     

     

     

  • ARX-788 (Recruiting)

    Updated: April 6th, 2016

    This is a phase 1 multiple dose-escalation study of ARX788, intravenously administered as a single agent in subjects with advanced breast cancer with multiple levels of HER2 expression.

    Phase 1a of this study is designed to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) in subjects with HER2 positive metastatic breast cancer that is in situ hybridization (ISH) positive (+) or immunohistochemistry (IHC) 3+.

    Phase 1b is designed to assess anticancer activity and safety in two different metastatic breast cancer cohorts - one for tumors that test as HER2 ISH+ OR IHC3+, and one for tumors that test as HER2 ISH- AND IHC 1+ or 2+.

    This trial is recruiting in Auckland, Wellington and Christchurch. View the full trial description for inclusion and exclusion criteria.

    To discuss you eligibility talk to your doctor, or contact:

    Auckland: Beth Caudwell - bcaudwell@adhb.govt.nz Phone: 09 307 4949 ext 23199

    Wellington: Maureen Blakemore - maureen.blakemore@ccdhb.org.nz Phone: 04 918 6109

    Christchurch: Becky Waghorn - rebecca.waghorn@cdhb.govt.nz Phone: 03 364 0145

  • KEYNOTE-086 (Recruiting)

    Updated: October 25th, 2015

    This is a two-part, Phase 2 study of pembrolizumab (Keytruda) monotherapy in participants with metastatic triple-negative breast cancer. Part 1 of the study will examine the efficacy and safety of pembrolizumab as first line or above treatment. Part 2 of the study, if done, will expand the investigation of pembrolizumab treatment in a subgroup of participants from Part 1 and will only start after enrolment in Part 1 has been completed.

    Inclusion Criteria: For the purposes of this study, neoadjuvant and/or adjuvant chemotherapy regimens do not count as a prior line of therapy.

    For Cohorts A and C: At least one systemic treatment for metastatic breast cancer; documented disease progression on the most recent therapy; Prior treatment must include an anthracycline and a taxane in the neoadjuvant, adjuvant, or metastatic setting

    For Cohort B: No prior systemic treatment for metastatic breast cancer; PD-L1-positive mTNBC.

    For Cohort C:- PD-L1 strong positive mTNBC

    Currently recruiting in Auckland (as well as in Australia).

    Sponsor: Merck Sharp & Dohme Corp - View full trial description. Contact Elizabeth Wardrop by email: ewardrop@adhb.govt.nz or phone: (09) 307 4949 ext. 22499

  • KEYNOTE-119 (Recruiting)

    Updated: April 6th, 2016

    This is a phase 3 study of pembrolizumab (Keytruda) monotherapy in participants with metastatic triple-negative breast cancer.

    In this study, participants with metastatic triple negative breast cancer (mTNBC) will be randomly assigned to receive either single agent pembrolizumab or single agent chemotherapy chosen by the treating physician (TPC) in accordance with local regulations and guidelines, consisting of either capecitabine, eribulin, gemcitabine, or vinorelbine.

    Inclusion criteria:

    - Metastatic triple negative breast cancer

    - Received one or two prior systemic treatments for metastatic triple negative breast cancer

    - Documented disease progression on most recent therapy

    - Previously treated with anthracycline and/or taxane in the neoadjuvant/adjuvant or metastatic setting

    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

    - Adequate organ function

    Currently recruiting in Christchurch and Waikato. View full trial description and for Christchurch details, contact Becky Upston: becky.upston@cdhb.health.nz, phone (03) 364 0145, or for Waikato details contact Wendy Thomas: wendy.thomas@waikatodhb.health.nz, phone: (07) 839 8976. Keynote -119 is also recruiting in Sydney, Australia. 

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  • ELIMINATE (Recruiting)

    Updated: February 17th, 2016

    The purpose of this phase II trial is to test whether giving two types of breast cancer treatment (chemotherapy and hormone treatment) at the same time is more effective than giving them one after the other (which is usually done). The type of breast cancer being treated in this study has a specific protein called “oestrogen receptor” (ER) in the cancer cells.

    This trial will be conducted in women with breast cancer that is large and/or attached to nearby tissues, for whom shrinkage of tumour using neoadjuvant therapy before surgery could mean the operation is easier and a smaller operation than mastectomy may be possible. Women with metastatic breast cancer are excluded.

    The current standard for women with larger ER positive breast cancer is preoperative chemotherapy alone, followed by surgery, then adjuvant endocrine therapy. Endocrine therapy is regarded as the mainstay of adjuvant treatment for women with receptor positive breast cancer, and neoadjuvant chemotherapy rarely results in complete disappearance of cancer by the time of surgery. The purpose of this trial is to examine whether combining chemotherapy and endocrine therapy is more effective than chemotherapy alone at downstaging receptor positive breast cancer before surgery.

    All participants will receive active treatment with neoadjuvant chemotherapy, with or without letrozole (and goserelin for pre/peri menopausal women).

    Run by: ANZBCTG at centres through New Zealand (Auckland, Waikato, Christchurch) and Australia. For more information, see trial details.

The trials below are available in Australian hospitals – these are intended for Australian patients. However, some Australian trials are willing to accept NZ patients (this may involve payment); and Kiwis moving to or living in Australia may also have access. To find out more, see the Quick Links above.

  • HER2+

     

  • Triple negative

     

  • Er+

     

  • Other

     

  • Surgery for Breast Cancer Metastases

     

  • REGISTER YOUR INTEREST

    Tell us if you’re interested in joining a clinical trial.
    We’ll keep searching for new studies
    ClinicalTrials@nzbcf.org.nz

  • Nala (Recruiting)
    Effect of neratinib and capecitabine versus the effect of lapatinib and capecitabine in HER2+ metastatic breast cancer patients.

    PANACEA (Recruiting)
    Efficacy of MK-3475 (pembrolizumab) to reverse Herceptin (trastuzumab) resistance and improve clinical outcomes in HER2+ breast cancer.

    STARTRK-2 (Recruiting)
    Basket study of Entrectinib (RXDX-101) for the treatment of patients with solid tumours harbouring NTRK1/2/3, ROS1 or ALK gene rearrangement.

    monarcHER (Recruiting)
    A study of Abemaciclib in women with HR+, HER2+ locally advanced or metastatic breast cancer.

    ASLAN001-003 (Recruiting)
    An open-label, randomized, parallel group Phase 2A/2B study to evaluate the clinical activity of ASLAN001 in combination with capecitabine compared with lapatinib in combinatin with capecitabine in patients with HER2+ metastatic breast cancer that has failed on prior trastuzumab (Herceptin) therapy.

    DTX-SPL8783 (Recruiting)
    A dose escalation study to evaluate the safety, tolerability and pharmacokinetics of DTX-SPL8783 (a docetaxel (DTX)-dendrimer conjugate) in patients with advanced solid tumours.

    GO29313 (Recruiting)
    An open-label, dose-escalation study of the safety and pharmacokinetics of MOXR0916 administrated intravenously as a single agent to patients with locally advanced or metastatic solid tumours.

  • KEYNOTE-086 (Recruiting)
    Pembrolizumab (Keytruda) for metastatic triple-negative breast cancer (MK-3475-086/).

    Safety and Pharmacokinetics of BGB-290 (Recruiting)
    Tolerability, treatment and pharmacokinetic profile of BGB-290 in patients with solid tumours – preferentially recruiting triple negative patients.

    STARTRK-2 (Recruiting)
    Basket study of Entrectinib (RXDX-101) for the treatment of patients with solid tumours harbouring NTRK1/2/3, ROS1 or ALK gene rearrangement.

    SOLACE (Recruiting)
    Toleration of Olaparib combined with cyclophosphamide in patients with BRCA-associated, or triple negative, breast cancer.

    MCS110 (Recruiting)
    Efficacy of MCS110 antibody therapy with carboplatin and gemcitabine.

    Effect of Cobimetinib and Paclitaxel as First-line Treatment (Pending)
    A study of cobimetinib in combination with paclitaxel as first-line treatment for patients with metastatic triple-negative breast cancer

    METRIC (Recruiting)
    Description: Treatment trial using CDX-011 (CR011-vcMMAE) in patients with metastatic, triple negative breast cancer.

    CPI-444 (Recruiting)
    Phase 1/1b Study to Evaluate the Safety and Tolerability of CPI-444 Alone and in Combination With Atezolizumab in Advanced Cancers

    JAVELIN Medley (Recruiting)
    A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies

    Veliparib (Recruiting)
    Efficacy and tolerability of veliparib/placebo in combination with carboplatin and paclitaxel in HER2-negative advanced BRCA-associated breast cancer.

    DTX-SPL8783 (Recruiting)
    A dose escalation study to evaluate the safety, tolerability and pharmacokinetics of DTX-SPL8783 (a docetaxel (DTX)-dendrimer conjugate) in patients with advanced solid tumours.

    GO29313 (Recruiting)
    An open-label, dose-escalation study of the safety and pharmacokinetics of MOXR0916 administrated intravenously as a single agent to patients with locally advanced or metastatic solid tumours

    Oral BGJ398 (Recruiting)
    An open-label, multi-centre, dose escalation study of Oral BGJ398 (Pan FGF-R Kinase Inhibitor) in adult patients with advanced solid malignancies.

    IMpassion130 (Recruiting)
    A Study of Atezolizumab (MPDL3280A) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Patients With Previously Untreated Metastatic Triple Negative Breast Cancer

  • ELIMINATE (Recruiting)
    Neoadjuvant chemotherapy +/- concurrent aromatase inhibitor endocrine therapy to down-stage large ER+ breast cancer (including locally advanced stage 3, but not metastatic stage 4).

    SANDPIPER (Recruiting)
    Taselisib and Fulvestrant in patients with advanced or metastatic breast cancer who have disease recurrence or progression after Aromatase Inhibitor therapy.

    HydranGea (Recruiting)
    Evaluating the efficacy, safety, and tolerability of GDC-0810 compared with fulvestrant in postmenopausal women with advanced or metastatic estrogen receptor positive (ER+) breast cancer resistant to aromatase inhibitor therapy.

    LEE011 and BYL719 (Recruiting / pending)
    Combination of LEE011 and BYL719 with Letrozole in adult, postmenopausal patients with advanced ER+ breast cancer.

    STARTRK-2 (Recruiting)
    Basket study of Entrectinib (RXDX-101) for the treatment of patients with solid tumours harbouring NTRK1/2/3, ROS1 or ALK gene rearrangement.

    SOLAR-1 (Recruiting)
    Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment

    monarcHER (Recruiting)
    A study of Abemaciclib in women with HR+, HER2+ locally advanced or metastatic breast cancer.

    Palbociclib + Letrozole (Recruiting)
    A study of palbociclib in combination with letrozole as treatment of post-menopausal women with ER+ breast cancer.

    FINESSE (Recruiting)
    Testing oral administration of lucitanib in patients with FGFR1-amplified or non-amplified ER+ metastatic breast cancer.

    LORELEI (Recruiting)
    Effect of Letrozole and GDC-0032 in postmenopausal women with ER+/HER- untreated, stage I-III (not stage IV metastatic) operable breast cancer.

    Veliparib (Recruiting)
    Efficacy and tolerability of veliparib/placebo in combination with carboplatin and paclitaxel in HER2-negative advanced BRCA-associated breast cancer.

    m-BEP (Recruiting)
    A study of BCL-2 Inhibition with ABT-199 in combination with Tamoxifen in metastatic ER+ breast cancer.

    DTX-SPL8783 (Recruiting)
    A dose escalation study to evaluate the safety, tolerability and pharmacokinetics of DTX-SPL8783 (a docetaxel (DTX)-dendrimer conjugate) in patients with advanced solid tumours.

    GO29313 (Recruiting)
    An open-label, dose-escalation study of the safety and pharmacokinetics of MOXR0916 administrated intravenously as a single agent to patients with locally advanced or metastatic solid tumours.

    Oral BGJ398 (Recruiting)
    An open-label, multi-centre, dose escalation study of Oral BGJ398 (Pan FGF-R Kinase Inhibitor) in adult patients with advanced solid malignancies.

  • CT707 (Recruiting)
    Verliparib combined with carboplatin and paclitaxel in HER2-negative Metastatic or locally Advanced BRCA-associated breast cancer.

    SOLACE (Recruiting)
    Toleration of Olaparib combined with cyclophosphamide in patients with BRCA-associated, or triple negative, breast cancer

    EMBRACA (Recruiting)
    Efficacy of BMN 673 versus protocol-specific physician's choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations.

    SETUP (Recruiting)
    Evaluation of the biological, clinical and imaging markers of tumour response where patients with advanced breast cancer have neoadjuvant chemotherapy with docetaxel and anthracycline based chemotherapy.

  • SAFRON II (Recruiting)
    A trial to evaluate the toxicity, quality of life, clinical efficacy and cost effectiveness of stereotactic ablative fractionated radiotherapy versus radiosurgery for oligometastatic neoplasia to the lung.

    BOSTON (Recruiting)
    Stereotactic ablative body radiosurgery in patients with oligometastases from breast cancer.

    BOSTON II (Pending)
    A pilot study to assess the safety and feasibility of stereotactic ablative body radiosurgery combined with Pembrolizumab in patients with oligometastases from breast cancer.

  • Nala (Recruiting)

    Updated: November 29th, 2016

    A Phase III randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting.

    Patients will be randomized in a 1:1 ratio to one of the following treatment arms:
    • Arm A: neratinib (240 mg once daily) + capecitabine (1500 mg/m^2 daily, 750 mg/m^2 twice daily [BID])
    • Arm B: lapatinib (1250 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID)

    Patients will receive either neratinib plus capecitabine combination or lapatinib plus capecitabine combination until the occurrence of death, disease progression, unacceptable toxicity, or other specified withdrawal criterion.

    Participants will be 18 years and older, have metastatic HER2+ breast cancer (current stage four), and have had prior treatment with at least two HER2 directed regimens for metastatic breast cancer.

    Run by: Puma Biotechnology Inc at several centres in Victoria, Australia – View full trial description and contact details.

  • PANACEA (Recruiting)

    Updated: November 29th, 2016

    A Phase Ib/II trial of an immune¬therapeutic approach to metastatic HER2-positive breast cancer.

    Pembrolizumab (also known as MK3475 and previously known as SCH 900475) is a potent and highly-selective humanized mAb of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. MK-3475 strongly enhances T lymphocyte immune responses in cultured blood cells from healthy human donors, cancer patients, and primates. MK-3475 also modulates the level of interleukin-2 (IL-2), tumor necrosis factor alpha (TNFα), interferon gamma (IFNγ), and other cytokines.

    The investigators therefore propose to evaluate if the addition of an immunotherapy can reverse trastuzumab resistance and improve clinical outcomes in HER2-positive disease.

    Peter MacCallum Cancer Centre in Melbourne has indicated a willingness to accept self-funded NZ patients into this trial.

    Run by: International Breast Cancer Study Group at various locations in Victoria, Australia – View full description and contact details.

  • STARTRK-2 (Recruiting)

    Updated: November 25th, 2016

    This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene rearrangement. Patients will be assigned to different baskets according to tumor type and gene rearrangement.

    Lung cancer and colorectal cancer are the main tumours of interest, but breast cancer solid tumours wills also be included.

    This trial is taking place at Flinders Medical Centre, Austin Hospital, Liverpool Hospital, Newcastle Private Hospital and Border Medical Oncology, all in Australia. 

    View full description and contact details.

  • MonarcHER (Recruiting)

    Updated: May 31st, 2016

    The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant or chemotherapy in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.

    This trial is taking place in three locations in Australia: Kurralta Park, Nedlands and St Leonards.

    View full description and contact details.

  • DTX-SPL8783 (Recruiting)

    Updated: November 4th, 2015

    This Phase I study is evaluating the safety, tolerability and pharmacokinetics of DTX-SPL8783 (a docetaxel (DTX)-dendrimer conjugate) in patients with advanced solid tumours. You may be eligible to join this study if you are aged over 18 years, have a histologically or cytologically confirmed advanced or metastatic cancer for which no standard or curative therapy exists, a life expectancy greater than 12 weeks, and your disease is measurable or evaluable by the Response Evaluation Criteria In Solid Tumours (RECIST).

    Participants in this study will be administered DEP(TM) Docetaxel (DTX-SPL8783) via intravenous infusion in escalating doses once every 3 weeks. The number of doses and dosage amounts administered to participants are dependent on any toxicities occurring at each dose level. The starting dose is 10mg/m2, increased by 1.4 – 2 times at each dose level. Treatment will be continued until tumour progression, unacceptable toxicity or withdrawal from the study based on investigator discretion or patient decision.

    Run by: Starpharma Pty Ltd at various locations in Victoria, Australia – View full trial description and contact details.

  • GO29313 (Recruiting)

    Updated: February 1st, 2016

    This is a first-in-human, Phase I, open-label, multicentre, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of MOXR0916 administered intravenously in patients with locally advanced or metastatic solid tumours that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective or intolerable, or is considered inappropriate. The planned duration of the study is approximately 3 years. This study will examine the effects of MOXR0916 on a wide range of cancers in the advanced stage.

    Run by: Genentech at various locations in Victoria, Australia – View full trial description and contact details.

  • KEYNOTE-086 (Recruiting)

    Updated: November 4th, 2015

    This is a two-part, Phase 2 study of pembrolizumab (Keytruda) monotherapy in participants with metastatic triple-negative breast cancer. Part 1 of the study will examine the efficacy and safety of pembrolizumab as first line or above treatment. Part 2 of the study, if done, will expand the investigation of pembrolizumab treatment in a subgroup of participants from Part 1 and will only start after enrolment in Part 1 has been completed.

    Inclusion Criteria: For the purposes of this study, neoadjuvant and/or adjuvant chemotherapy regimens do not count as a prior line of therapy.

    For Cohorts A and C: At least one systemic treatment for metastatic breast cancer; documented disease progression on the most recent therapy; Prior treatment must include an anthracycline and a taxane in the neoadjuvant, adjuvant, or metastatic setting

    For Cohort B: No prior systemic treatment for metastatic breast cancer; PD-L1-positive mTNBC.

    For Cohort C:- PD-L1 strong positive mTNBC

    This trial is running at locations in NZ and Australia. 

    Sponsor: Merck Sharp & Dohme Corp - View full trial description and contact details.

  • Safety and Pharmacokinetics of BGB-290 (Recruiting)

    Updated: February 4th, 2016

    This Phase I study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as BGB-290 in patients with solid tumours. Triple negative breast cancer patients will be preferentially recruited.

    Participants must have a life expectancy of more than 12 weeks, an histologically or cytologically confirmed advanced or metastatic solid tumour for which no effective standard therapy is available, able to swallow and retain oral medication, and have adequate bone marrow, liver and renal functions. Women participants must either be of non-childbearing potential or use adequate contraception before entry and throughout the study until 28 days after the last investigational product administration.

    The primary outcome measure is the number of participants with adverse effects.

    The secondary outcome measures are: Area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration, Area under the plasma concentration-time curve from time 0 to infinity time, Maximum plasma concentration, Time to reach maximum plasma concentration, Terminal elimination half-life, Tumour response and PARP inhibition activity of BGB-290.

    Run by: BeiGene at various locations in Australia – View full trial description and contact details.

  • STARTRK-2 (Recruiting)

    Updated: May 24th, 2016

    This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene rearrangement. Patients will be assigned to different baskets according to tumor type and gene rearrangement.

    Lung cancer and colorectal cancer are the main tumours of interest, but breast cancer solid tumours wills also be included.

    This trial is taking place in Wodonga, Victoria, Australia.

    View full description and contact details.

  • MCS110 (Recruiting)

    Updated: November 25th, 2016

    This phase II study is testing whether MCS110 antibody therapy improves the efficacy of carboplatin and gemcitabine, for patients with advanced triple negative breast cancer.

    Participants must be females aged 18+ with confirmed triple negative advanced breast cancer and high TAM content.

    The primary outcome measure is progression-free survival.

    This study is recruiting in Perth, Australia. For more information and contact details view the full trial description.

  • Effect of Cobimetinib and Paclitaxel as First-line Treatment (Recruiting)

    Updated: November 29th, 2016

    This multistage, randomized, Phase II, double-blind, multicentre, placebo-controlled trial will evaluate the safety and tolerability and estimate the efficacy of cobimetinib + paclitaxel versus placebo + paclitaxel in patients with metastatic or locally advanced, triple-negative adenocarcinoma of the breast that have not received prior systemic therapy for metastatic breast cancer (MBC). An open-label safety run-in stage of the combination cobimetinib + paclitaxel will undergo an Internal Safety Review before starting the enrollment of patients into the expansion double-blind stage of this study.

    Patients may continue on study treatment until the development of progressive disease, unacceptable toxicity, and/or consent withdrawal. The target sample size is 12 patients for the safety run-in stage and approximately 100 patients in the expansion stage.

    Run by: Hoffmann-La Roche at various locations in Australia – View full trial description and contact details.

  • METRIC (Recruiting)

    Updated: November 29th, 2016

    CDX-011 consists of an antibody attached to a drug, monomethyl auristatin E (MMAE), that can kill cancer cells. The antibody delivers the drug to cancer cells by attaching to a protein called glycoprotein NMB (GPNMB) that is expressed on the cancer cell. The MMAE is then released inside of the cell, where it interferes with cell growth and may lead to cell death. This Phase II study will examine the effectiveness and safety of CDX-011 in patients with advanced TNBC that makes the GPNMB protein. The effect of CDX-011 will be compared to treatment with capecitabine. Eligible patients who enrol in the study will be randomly assigned (by chance) to receive treatment with CDX-011 or with capecitabine. For every three patients enrolled, two will receive CDX-011 and one will receive treatment with capecitabine. All patients enrolled in the study will be closely monitored to determine if their cancer is responding to treatment and for any side effects that may occur.

    Run by: Celldex Therapeutics at various locations in Australia – View full trial description and contact details.

  • CPI-444 (Recruiting)

    Updated: August 8th, 2016

    This is a phase 1 trial looking at CPI-444, a new drug that targets the adenosine-A2A receptor.

    Adenosine stops the immune system from attacking tumour cells, so this drug is designed to prevent adenosine from working, thus increasing the immune system’s ability to fight the cancer cells.

    The trial is to determine whether the drug is safe, what side-effects it causes, and how well it works, both by itself, and in combination with another treatment.

    This trial is for women with advanced, triple negative breast cancer, and is taking place in Brisbane and Melbourne.

    View the full trial description and contact details.

  • JAVELIN Medley (Recruiting)

    Updated: November 25th, 2016

    This is a Phase 1b/2 dose-optimization study to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of avelumab (MSB0010718C) in combination with other cancer immunotherapies in patients with locally advanced or metastatic solid tumors.

    The primary purpose is to assess the safety and early signs of efficacy of various avelumab combinations with other cancer immunotherapies, optimizing dosing regimens as appropriate, in a limited series of indications.

    The trial is open for recruitment at three sites in New South Wales, Australia, and one in Victoria, Australia.

    View the full trial description and contact details.

  • Veliparib (Recruiting)

    Updated: November 29th, 2016

    The study seeks to evaluate the efficacy and tolerability of veliparib/placebo in combination with carboplatin and paclitaxel in HER2-negative metastatic or locally advanced, unresectable, BRCA-associated breast cancer.

    This study is recruiting at various sites in Australia.

    View the full trial description and contact details.

  • DTX-SPL8783 (Recruiting)

    Updated: November 4th, 2015

    This Phase I study is evaluating the safety, tolerability and pharmacokinetics of DTX-SPL8783 (a docetaxel (DTX)-dendrimer conjugate) in patients with advanced solid tumours. You may be eligible to join this study if you are aged over 18 years, have a histologically or cytologically confirmed advanced or metastatic cancer for which no standard or curative therapy exists, a life expectancy greater than 12 weeks, and your disease is measurable or evaluable by the Response Evaluation Criteria In Solid Tumours (RECIST).

    Participants in this study will be administered DEP(TM) Docetaxel (DTX-SPL8783) via intravenous infusion in escalating doses once every 3 weeks. The number of doses and dosage amounts administered to participants are dependent on any toxicities occurring at each dose level. The starting dose is 10mg/m2, increased by 1.4 – 2 times at each dose level. Treatment will be continued until tumour progression, unacceptable toxicity or withdrawal from the study based on investigator discretion or patient decision.

    Run by: Starpharma Pty Ltd at various locations in Victoria, Australia – View full trial description and contact details.

  • GO29313 (Recruiting)

    Updated: February 1st, 2016

    This is a first-in-human, Phase I, open-label, multicentre, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of MOXR0916 administered intravenously in patients with locally advanced or metastatic solid tumours that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective or intolerable, or is considered inappropriate. The planned duration of the study is approximately 3 years. This study will examine the effects of MOXR0916 on a wide range of cancers in the advanced stage.

    Run by: Genentech at various locations in Victoria, Australia – View full trial description and contact details.

  • IMpassion130 (Recruiting)

    Updated: November 29th, 2016

    This study is being conducted to determine the efficacy and safety in using Atezolizumab (MPDL3280A) in combination with nab-paclitaxel in treating patients with metastatic breast cancer.

    The safety of single-agent nab-paclitaxel has been determined in previous studies of patients with metastatic breast cancer, and preliminary data shows the use of MPDL3280A is safe to use in combination with chemotherapy.

    View full trial description and contact info.

  • ELIMINATE (Recruiting)

    Updated: February 17th, 2016

    The purpose of this phase II trial is to test whether giving two types of breast cancer treatment (chemotherapy and hormone treatment) at the same time is more effective than giving them one after the other (which is usually done). The type of breast cancer being treated in this study has a specific protein called “oestrogen receptor” (ER) in the cancer cells.

    This trial will be conducted in women with breast cancer that is large and/or attached to nearby tissues, for whom shrinkage of tumour using neoadjuvant therapy before surgery could mean the operation is easier and a smaller operation than mastectomy may be possible. Women with metastatic breast cancer are excluded.

    The current standard for women with larger ER positive breast cancer is preoperative chemotherapy alone, followed by surgery, then adjuvant endocrine therapy. Endocrine therapy is regarded as the mainstay of adjuvant treatment for women with receptor positive breast cancer, and neoadjuvant chemotherapy rarely results in complete disappearance of cancer by the time of surgery. The purpose of this trial is to examine whether combining chemotherapy and endocrine therapy is more effective than chemotherapy alone at downstaging receptor positive breast cancer before surgery.

    All participants will receive active treatment with neoadjuvant chemotherapy, with or without letrozole (and goserelin for pre/peri menopausal women).

    Run by: ANZBCTG at centres through New Zealand (Auckland, Waikato, Christchurch) and Australia. For more information, see trial details.

  • SANDPIPER (Recruiting)

    Updated: November 29th, 2016

    This international, multicentre, randomized, double-blinded, placebo-controlled Phase III study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, PIK3CA-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy. The anticipated duration of the study is approximately 3.5 years.

    The primary outcome measure is progression-free survival.

    The secondary outcome measures are overall survival, overall objective response rate, clinical benefit defined as objective response or stable disease lasting for at least 24 weeks since randomisation, duration of objective response and incidence of adverse events, according National Cancer Institute Common Terminology Criteria for Adverse Events.

    Run by: Hoffmann-La Roche at several centres in Australia – View full trial description and contact details.

  • HydranGea (Recruiting)

    Updated: November 25th, 2016

    The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of GDC-0810 compared with fulvestrant in postmenopausal women with advanced or metastatic estrogen receptor positive (ER+)/ human epidermal growth factor receptor 2 negative (HER2) breast cancer resistant to aromatase inhibitor therapy. The trial is open for recruitment at various sights in New South Wales, South Australia, Tasmania and Victoria. 

    View full trial description and contact details.

  • LEE011 and BYL719 (Recruiting)

    Updated: November 29th, 2016

    This Phase I/II study will investigate the combination of LEE011 (CDK4/6i) and BYL719 (PI3K-alpha-i) with letrozole in patients with advanced ER+/HER2- breast cancer.

    In Phase Ib there are three dose escalation cohorts that will enrol sequentially. Arm 1 is the escalation of the double combination LEE011 + letrozole; Arm 2 is the dose escalation of the double combination of BYL719 + letrozole. The two double combinations will be followed by Arm 3 the dose escalation of the triple combination of LEE011 + BYL719 with letrozole. The three dose escalation cohorts will enrol patients with ER+/HER2- BC with any number of prior lines of endocrine therapy with up to one prior cytotoxic regimen in the metastatic or locally advanced setting. Pre- and post-treatment tumour biopsies are required in the three dose escalation cohorts. Once the RP2D/MTD of each double regimen is identified, dose expansion cohorts of each of these two combinations will open and will enroll in the first-line setting to confirm the doses selected in each double combination; archival tumour tissue is required in these cohorts, although pre- and post-biopsies in these expansion cohorts are optional. Once the dose is identified for the triple combination, the randomized, three-arm Phase II portion of the study will commence enrolment. This part of the trial will enrol in the first line setting in patients with ER+/HER2- BC and will randomize patients in a 1:1:1 ratio to either double regimen (LEE011+letrozole or BYL719 +letrozole) or the triple combination of LEE011+BYL719 with letrozole.

    Run by: Novartis Pharmaceuticals at various locations in Victoria, Australia – View full trial description and contact details.

  • STARTRK-2 (Recruiting)

    Updated: May 24th, 2016

    This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene rearrangement. Patients will be assigned to different baskets according to tumor type and gene rearrangement.

    Lung cancer and colorectal cancer are the main tumours of interest, but breast cancer solid tumours wills also be included.

    This trial is taking place in Wodonga, Victoria, Australia.

    View full description and contact details.

  • SOLAR-1 (Recruiting)

    Updated: November 25th, 2016

    The purpose of this phase 3 study is to determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.

    Patients must have received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.

    The study is taking place in Wahroonga, New South Wales.

    View the full trial description and contact details.

  • MonarcHER (Recruiting)

    Updated: May 31st, 2016

    The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant or chemotherapy in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.

    This trial is taking place in three locations in Australia: Kurralta Park, Nedlands and St Leonards.

    View full description and contact details.

  • Palbociclib + Letrozole (Recruiting)

    Updated: November 29th, 2016

    Palbociclib is CDK4 inhibitor – a new type of drug being used to treat metastatic, ER+ breast cancer.

    You may be eligible for this trial if you are post-menopausal, and have advanced breast cancer that is ER positive and/or PR positive and HER2 negative.

    All patients enrolled in this trial will be put on palbociclib, and some will also be on letrozole.

    The study is recruiting at multiple sites in Sydney, Melbourne, Gold Coast and Brisbane.

    View the full trial description and email clinicaltrials@nzbcf.org.nz for contact details.

  • FINESSE (Recruiting)

    Updated: March 1st, 2015

    The aim of the Phase II study is to evaluate the objective response rate (ORR) of single agent lucitanib in metastatic breast cancer patients with FGFR1-amplified, FGFR1-non amplified with 11q amplification, or FGFR1-non amplified without 11q amplification.

    Participants will be females, aged 18 years and over with an estimated life expectancy of three months or more. There must be an accessible metastatic lesion for biopsy and at least one archived metastatic tumour sample. Women must have adequate haematological, hepatic and renal functions and those with childbearing ability must provide a negative pregnancy test prior to initiation of the study drug, and willingness to use an effective contraception.

    Run by: Servier at various locations in Australia – View full trial description and contact details.

  • LORELEI (Recruiting)

    Updated: September 9th, 2015

    This is a two-arm, randomized, double-blind, multi-centre, pre-operative Phase II study to evaluate the effect of combining letrozole and GDC-0032 versus letrozole and placebo in postmenopausal women with ER+/HER2- untreated, Stage I-III operable breast cancer. Patients will be randomized into one of the two treatment arms with a 1:1 randomization ratio. Letrozole at 2.5 mg will be dosed once daily plus either GDC-0032 at 6 mg or placebo on a 5 days-on/ 2 days-off schedule for a total of 16 weeks.

      Participants must be female, post-menopausal with historically confirmed invasive breast carcinoma with all of the following characteristics:
      • Primary tumour >/= 2 cm in largest diameter (cT1-3)
      • Stage I to operable Stage III breast cancer
      • ER-positive and HER2-negative breast cancer
      • Breast cancer eligible for primary surgery
      • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
      • Fasting glucose </= 125 mg/dL
      • Adequate haematological, renal, and hepatic function
      • Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

    The primary outcome measure is the objective response rate and pathologic complete response rate in breast and axilla.

    The secondary outcome measures are a change in Ki67 levels, preoperative endocrine prognostic index, change in tumour volume, incidence of adverse events, health-related quality of life measured by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30/BR23.

    Run by: Genentech Inc at several centres in Australia – View full trial description and contact details.

  • Veliparib (Recruiting)

    Updated: November 29th, 2016

    The study seeks to evaluate the efficacy and tolerability of veliparib/placebo in combination with carboplatin and paclitaxel in HER2-negative metastatic or locally advanced, unresectable, BRCA-associated breast cancer.

    This study is recruiting at various sites in Australia.

    View the full trial description and contact details.

  • mBEP (Recruiting)

    Updated: November 5th, 2015

    It is hypothesised that the combination treatment of ABT-199 and tamoxifen will be safe and will show a sufficient level of activity in patients with ER+, BCL-2 positive metastatic breast cancer to warrant further investigation in later phase trials.

    The primary endpoints of this Phase IB study are establishments of maximum tolerated dose (MTD) and dose limiting toxicities (DLTs), both reported within the first 4 weeks of treatment with the combination of ABT-199 and tamoxifen. This will be measured by assessing side-effects experienced by subjects during the first 4 weeks of treatment. Subjects must have ER+ metastatic breast cancer, not have received tamoxifen within the last 3 months and have a life expectancy of 6 months or more.

    Run by: AbbVie at various locations in Australia – View full trial description and contact details. For the trial taking place at the Peter MacCallum Cancer Centre, Melbourne, please contact: shackleton@wehi.edu.au.

  • DTX-SPL8783 (Recruiting)

    Updated: November 4th, 2015

    This Phase I study is evaluating the safety, tolerability and pharmacokinetics of DTX-SPL8783 (a docetaxel (DTX)-dendrimer conjugate) in patients with advanced solid tumours. You may be eligible to join this study if you are aged over 18 years, have a histologically or cytologically confirmed advanced or metastatic cancer for which no standard or curative therapy exists, a life expectancy greater than 12 weeks, and your disease is measurable or evaluable by the Response Evaluation Criteria In Solid Tumours (RECIST).

    Participants in this study will be administered DEP(TM) Docetaxel (DTX-SPL8783) via intravenous infusion in escalating doses once every 3 weeks. The number of doses and dosage amounts administered to participants are dependent on any toxicities occurring at each dose level. The starting dose is 10mg/m2, increased by 1.4 – 2 times at each dose level. Treatment will be continued until tumour progression, unacceptable toxicity or withdrawal from the study based on investigator discretion or patient decision.

    Run by: Starpharma Pty Ltd at various locations in Victoria, Australia – View full trial description and contact details.

  • GO29313 (Recruiting)

    Updated: February 1st, 2016

    This is a first-in-human, Phase I, open-label, multicentre, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of MOXR0916 administered intravenously in patients with locally advanced or metastatic solid tumours that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective or intolerable, or is considered inappropriate. The planned duration of the study is approximately 3 years. This study will examine the effects of MOXR0916 on a wide range of cancers in the advanced stage.

    Run by: Genentech at various locations in Victoria, Australia – View full trial description and contact details.

  • CT707 (Recruiting)

    Updated: April 3rd, 2016

    A Phase 3 randomized, placebo-controlled trial of carboplatin and paclitaxel with or without the Poly ADP-ribose Polymerase (PARP) Inhibitor Veliparib (ABT-888) in HER2-Negative metastatic or locally advanced unresectable BRCA-associated breast cancer.

    The study seeks to evaluate the efficacy and tolerability of veliparib/placebo in combination with carboplatin and paclitaxel in HER2-negative metastatic or locally advanced, unresectable, BRCA-associated breast cancer.

    Run by: AbbVie at Royal Melbourne Hospital, Victoria, Australia – View full trial description and contact details.

  • EMBRACA (Recruiting)

    Updated: November 29th, 2016

    The purpose of this open-label, 2:1 randomized Phase III trial is to compare the safety and efficacy of BMN 673 versus protocol-specific physician's choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations.

    Run by: BioMarin Pharmaceutical at various locations in Victoria, Australia – View full trial description and contact details.

  • SETUP (Recruiting)

    Updated: November 2nd, 2015

    The purpose of this trial is to identify markers that indicate tumour response to chemotherapy. Patients will be given either docetaxcel or anthracycline based chemotherapy prior to surgery. The tumour will be measured both before and after the chemotherapy. All the measurements including radiological and laboratory from the tumour tissue are then assessed. Trial runs for 24 weeks.

    Recruiting at Monash until 2017.

    Run by: Sanofi Aventis and Southern Health at Monash Medical Centre, Melbourne, Victoria, Australia – View full trial description and contact details.

  • SAFRON II (Recruiting)

    Updated: May 9th, 2016

    This Phase II study is evaluating the safety and effectiveness of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of lung tumours. You may be eligible to join this study if: you are aged 18 years or above; have 1-3 lung metastases from any non-haematological primary tumour; you are medically inoperable, high risk or have decline surgery; and you have not had any previous high-dose radiotherapy to the chest region.

    SABR is an exciting novel radiotherapy technique that is delivered over very few sessions. In the case of limited lung metastases, SABR can result in long-term survival. It is non-invasive and associated with high rates of tumour control and relatively low toxicity. Additionally, the large doses of precision radiotherapy involved may evoke a strong immune response to recognise and attack any remaining tumour cells. There are two SABR techniques emerging in Australia; fractionated and single fraction treatments. Participants in this study will be randomly (by chance) allocated to receive either multi-fraction SABR (4 fractions over 2 weeks) or single fraction SABR (1 fraction only). All participants will be assessed at regular intervals post treatment in order to evaluate the toxicity, Quality of Life, clinical efficacy and cost effectiveness of single fraction SABR compared to multi-fraction SABR. The follow-up visits occur every 3 months in 1st year post treatment, then every 4 months in the second year and then 6 monthly until study closure (2 years after the last participant finishes study treatment).

    This study is likely to continue recruiting until 2017.

    Run by: Trans Tasman Radiation Oncology Group (TROG) at Peter MacCallum Cancer Centre in Melbourne, Victoria, Australia – View full trial description and contact details.

  • BOSTON (Recruiting)

    Updated: November 5th, 2015

    This study aims to investigate the feasibility and tolerability of stereotactic ablative body radiosurgery in patients with oligometastases from breast cancer. You may be eligible to join this study if you are a female aged 18 years or above who has a confirmed primary diagnosis of breast cancer, with evidence of 1 to 3 bone metastases.

    Stereotactic ablative body radiotherapy (SABR) is a new form of cancer treatment involving high precision radiotherapy. Standard radiotherapy treatment is usually delivered in small doses over many treatments (usually 5 to 20 treatments). SABR treatment is different as it uses a dose of radiation delivered in 1 or 2 treatments that is much higher than standard radiotherapy dosages with the aim of destroying all cancer cells at the site of treatment. The total dose of radiation may be 5-10 times higher than standard radiotherapy doses. SABR treatment appears to be effective in controlling cancer in other sites elsewhere in the body, including the lung, kidney and the liver. All participants in this study will be treated with SABR delivered in 1-3 sessions of 45-90 minutes duration. Participants will be regularly monitored during treatment and for a period of up to 24 months post treatment in order to evaluate the feasibility and tolerability of treatment, as well as treatment response and quality of life.

    Run by: Peter MacCallum Cancer Centre at various locations in Victoria, Australia – View full trial description and contact details.

  • BOSTON II (Recruiting)

    Updated: November 29th, 2016

    This Phase I study will investigate the combined use of stereotactic ablative body radiosurgery (SABR) treatment followed by an investigational drug, called Pembrolizumab, as treatment for metastatic breast cancer. You may be eligible to join this study if you are aged 18 years or above, diagnosed with breast cancer that has metastasised to the bones, lungs or isolated nodes.

    The study aims to determine if SABR treatment in combination with Pembrolizumab is safe for patients with oligometastatic breast cancer and can induce significant changes in host anti-tumor immunity which may lead to prolonged local and distant disease control. All participants will receive SABR treatment (one or more sessions, as required) followed by 8 cycles of Pembrolizumab (venous infusion, one cycle every three weeks). During each cycle, the doctor will review your general health and conduct a physical assessment as well as blood tests and a quality of life questionnaire. Radiological assessments may also be performed as necessary during and after treatment. Participants will be followed up for up to 2 years from the completion of the SABR treatment.

    Run by: Peter MacCallum Cancer Centre at the Peter MacCallum Cancer Centre in Melbourne, Victoria, Australia – View full trial description and contact details.

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