EARLY BREAST CANCER TRIALS

Clinical Trials currently recruiting (open to new patients) or pending for patients diagnosed with Stage 0 DCIS (pre-cancer), or Stage 1 or 2 (early) 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 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 Are we out of date?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 QuickLinks 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

  • BCAR (Recruiting)

    Updated: February 15, 2016

    You may be able to take part in this trial if you are scheduled for a mastectomy or a lumpectomy for breast cancer.

    The purpose of this study is to compare the cancer recurrence rates in patients who either have regional pain relief or opioid pain relief methods as part of their routine general anaesthesia. Both of these options are routine pain management methods worldwide.

    You will randomly be assigned to one of these two groups: Opioid pain relief group: You will have your general anaesthesia with opioids given to treat your pain. Patients having breast surgery at Auckland Hospital usually have this type of anaesthesia even if they are not part of the study.

    Regional (nerve block) pain relief group: As part of your anaesthesia you will have either an epidural or paravertebral block and deep sedation. We use this type of approach for many other surgeries but is less common for breast surgery.

    View full trial description, and contact Davina McAllister for more information. Email: davinams@adhb.govt.nz, Ph: 09 375 7095

  • A Dose-Finding Study of Perjeta in Combination With Herceptin in Early Breast Cancer (Recruiting)

    Updated: March 10th, 2017

    This study has two-parts. Part 1 is designed to determine the most effective dose of subcutaneous Perjeta, either injected alone or mixed with Herceptin. The researchers are looking for a dose that has similar effects to intravenous Perjeta.

    Part 2 is designed to confirm the right dose for women with EBC, based on its safety, side effects, and effectiveness.

    The researchers are recruiting women with early HER2+ breast cancer. They’re also looking for healthy men to be part of the trial.

    The trial is currently recruiting in Auckland and Christchurch.

    If you’re interested in taking part in this trial, send us a message: clinicaltrials@nzbcf.org.nz.

    View the full trial description.

  • POSNOC (Recruiting)

    Updated: November 29th, 2016

    For women with early breast cancer undergoing surgery, the surgeon removes one or two lymph glands from the armpit on the side of the cancer to check if the cancer has spread to the lymph glands. 

    For about a quarter of women, the breast cancer has spread to the lymph glands. Currently, these women undergo further treatment to their armpit (axillary treatment). This is either a second operation to remove all the lymph glands in the armpit or radiotherapy to the armpit.

    These women will also receive chemotherapy or endocrine therapy (hormone therapy), or both.

    We now know that these treatments are more advanced and very good at preventing the cancer from coming back. So the armpit treatment may no longer be needed.

    The aim of the study is to find out if armpit treatment is of benefit in women with cancer spread to one or two lymph glands, receiving one or more of drug treatments (chemotherapy or endocrine therapy).

    This trial is recruiting in Waikato, Palmerston North and Rotorua. 

    View the full trial description. If you have any questions about the trial, we encourage you to discuss these with your breast surgeon. If you're interested in joining the trial, contact Jenni Scarlet - Jenni.Scarlet@waikatodhb.health.nz.

  • BCAR (Recruiting)

    Updated: February 15, 2016

    You may be able to take part in this trial if you are scheduled for a mastectomy or a lumpectomy for breast cancer.

    The purpose of this study is to compare the cancer recurrence rates in patients who either have regional pain relief or opioid pain relief methods as part of their routine general anaesthesia. Both of these options are routine pain management methods worldwide.

    You will randomly be assigned to one of these two groups: Opioid pain relief group: You will have your general anaesthesia with opioids given to treat your pain. Patients having breast surgery at Auckland Hospital usually have this type of anaesthesia even if they are not part of the study.

    Regional (nerve block) pain relief group: As part of your anaesthesia you will have either an epidural or paravertebral block and deep sedation. We use this type of approach for many other surgeries but is less common for breast surgery.

    Contact Davina McAllister for more information. Email: davinams@adhb.govt.nz, Ph: 09 375 7095

  • POSNOC (Recruiting)

    Updated: November 29th, 2016

    For women with early breast cancer undergoing surgery, the surgeon removes one or two lymph glands from the armpit on the side of the cancer to check if the cancer has spread to the lymph glands. 

    For about a quarter of women, the breast cancer has spread to the lymph glands. Currently, these women undergo further treatment to their armpit (axillary treatment). This is either a second operation to remove all the lymph glands in the armpit or radiotherapy to the armpit.

    These women will also receive chemotherapy or endocrine therapy (hormone therapy), or both.

    We now know that these treatments are more advanced and very good at preventing the cancer from coming back. So the armpit treatment may no longer be needed.

    The aim of the study is to find out if armpit treatment is of benefit in women with cancer spread to one or two lymph glands, receiving one or more of drug treatments (chemotherapy or endocrine therapy).

    This trial is recruiting in Waikato, Palmerston North and Rotorua. 

    View the full trial description. If you have any questions about the trial, we encourage you to discuss these with your breast surgeon. If you're interested in joining the trial, contact Jenni Scarlet - Jenni.Scarlet@waikatodhb.health.nz.

  • ELIMINATE (Recruiting)

    Updated: February 28th, 2017

    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.

    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 or get in touch with the Eliminate trial team. Email: eliminate@anzbctg.org.

  • BCAR (Recruiting)

    Updated: February 15, 2016

    You may be able to take part in this trial if you are scheduled for a mastectomy or a lumpectomy for breast cancer.

    The purpose of this study is to compare the cancer recurrence rates in patients who either have regional pain relief or opioid pain relief methods as part of their routine general anaesthesia. Both of these options are routine pain management methods worldwide.

    You will randomly be assigned to one of these two groups: Opioid pain relief group: You will have your general anaesthesia with opioids given to treat your pain. Patients having breast surgery at Auckland Hospital usually have this type of anaesthesia even if they are not part of the study.

    Regional (nerve block) pain relief group: As part of your anaesthesia you will have either an epidural or paravertebral block and deep sedation. We use this type of approach for many other surgeries but is less common for breast surgery.

    View full trial description, and contact Davina McAllister for more information. Email: davinams@adhb.govt.nz, Ph: 09 375 7095

  • POSNOC (Recruiting)

    Updated: November 29th, 2016

    For women with early breast cancer undergoing surgery, the surgeon removes one or two lymph glands from the armpit on the side of the cancer to check if the cancer has spread to the lymph glands. 

    For about a quarter of women, the breast cancer has spread to the lymph glands. Currently, these women undergo further treatment to their armpit (axillary treatment). This is either a second operation to remove all the lymph glands in the armpit or radiotherapy to the armpit.

    These women will also receive chemotherapy or endocrine therapy (hormone therapy), or both.

    We now know that these treatments are more advanced and very good at preventing the cancer from coming back. So the armpit treatment may no longer be needed.

    The aim of the study is to find out if armpit treatment is of benefit in women with cancer spread to one or two lymph glands, receiving one or more of drug treatments (chemotherapy or endocrine therapy).

    This trial is recruiting in Waikato, and will open for recruitment soon in Palmerston North and Rotorua. 

    View the full trial description. If you have any questions about the trial, we encourage you to discuss these with your breast surgeon. If you're interested in joining the trial, contact Jenni Scarlet - Jenni.Scarlet@waikatodhb.health.nz.

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 QuickLinks 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

  • APBI Study (Recruiting)
    In women diagnosed with localised breast cancer, does Accelerated Partial Breast Irradiation (APBI) demonstrate acceptable general cosmesis with an improved quality of life?

  • OLYMPIA (Recruiting)
    Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2- primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.

    APBI Study (Recruiting)
    In women diagnosed with localised breast cancer, does Accelerated Partial Breast Irradiation (APBI) demonstrate acceptable general cosmesis with an improved quality of life?

  • ELIMINATE (Recruiting)
    Neoadjuvant chemotherapy +/- concurrent aromatase inhibitor endocrine therapy to down-stage large ER+ breast cancer.

    PALLAS (Recruiting)
    Palbociclib with standard endocrine therapy vs standard endocrine therapy alone

    CBYL719A2201 (Recruiting)
    Effect of Letrozole with or without BYL719 or Buparlisib for the neoadjuvant treatment of ER+/HER2- breast cancer in postmenopausal women.

    PENELOPE-B (Recruiting)
    Study evaluating Palbociclib (a cyclin-dependent Kinase 4/6 Inhibitor) in patients with HR+ and HER2 neutral primary breast cancer with high relapse risk after neoadjuvant chemotherapy.

    SETUP AIM (Recruiting)
    A neo-adjuvant pilot study in operable hormone sensitive breast cancer in postmenopausal women, evaluating tumours undergoing pre-operative therapy with aromatase inhibitors and metformin.

    APBI Study (Recruiting)
    In women diagnosed with localised breast cancer, does Accelerated Partial Breast Irradiation (APBI) demonstrate acceptable general cosmesis with an improved quality of life.

    POSITIVE (Recruiting)
    A study to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with higher risk of breast cancer recurrence.

  • No trials currently recruiting or pending in Australia

     

     

     

     

  • APBI Study (Recruiting)

    Updated: February 24th, 2016

    This study is evaluating the feasibility of accelerated partial breast irradiation (APBI) in women with breast cancer. You may be eligible to join this study if you are a woman above 50 years of age who has been diagnosed with early or local breast cancer.

    All participants in this study will undergo a procedure called accelerated partial breast irradiation (APBI). This involves the insertion of approximately 10 to 25 hollow plastic tubes (catheters) into the region surrounding the surgical excision cavity of the breast under general anaesthetic. These catheters will remain in situ for 7 days. The catheters are then connected to a computerised machine which remotely loads a high dose rate radioactive source into the catheters and determines the amount of time that the source remains in each specific dwell position. In doing so, the dose of radiation is individually tailored to target the areas which are at the highest risk of disease recurrence whilst minimising dose to the surrounding normal structures such as the lungs, heart and contralateral breast. Treatment is delivered twice daily over 5 days in total with the catheters. Each treatment will take 10-15 minutes with an inter-fraction interval of at least 6 hours.

    Run by: Dr Yaw Chin at St George Public Hospital, NSW - View full trial description or email yaw.chin@sesiahs.health.nsw.gov.au

  • OLYMPIA (Recruiting)

    Updated: February 1st, 2017

    Participants will have non-metastatic primary triple negative breast cancer, with documented mutation in BRCA1 or BRCA 2 predicted or suspected to be deleterious, have completed adequate breast and axilla surgery and have completed six cycles of neoadjuvant or adjuvant chemotherapy including anthracyclines, taxanes or both.

    Run by: AstraZeneca at various locations in Australia - View full trial description and contact Andrew Tutt (information.centre@astrazeneca.com)

  • This trial investigates the effect of olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2- primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy. The primary outcome measure is the efficacy of adjuvant treatment with olaparib on Invasive Disease Free Survival.

  • APBI Study (Recruiting)

    Updated: February 24th, 2016

    This study is evaluating the feasibility of accelerated partial breast irradiation (APBI) in women with breast cancer. You may be eligible to join this study if you are a woman above 50 years of age who has been diagnosed with early or local breast cancer.

    All participants in this study will undergo a procedure called accelerated partial breast irradiation (APBI). This involves the insertion of approximately 10 to 25 hollow plastic tubes (catheters) into the region surrounding the surgical excision cavity of the breast under general anaesthetic. These catheters will remain in situ for 7 days. The catheters are then connected to a computerised machine which remotely loads a high dose rate radioactive source into the catheters and determines the amount of time that the source remains in each specific dwell position. In doing so, the dose of radiation is individually tailored to target the areas which are at the highest risk of disease recurrence whilst minimising dose to the surrounding normal structures such as the lungs, heart and contralateral breast. Treatment is delivered twice daily over 5 days in total with the catheters. Each treatment will take 10-15 minutes with an inter-fraction interval of at least 6 hours.

    Run by: Dr Yaw Chin at St George Public Hospital, NSW - View full trial description and email yaw.chin@sesiahs.health.nsw.gov.au

  • ELIMINATE (Recruiting)

    Updated: February 28th, 2017

    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.

    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 and Australia. For more information, see trial details.

  • PALLAS (Recruiting)

    Updated: February 1st, 2017

    The purpose of this study is to determine whether adding 2 years of palbociclib to standard adjuvant endocrine therapy will benefit patients with HR+/HER2- early breast cancer.

    This trial is suitable for women or men with stage 2 or stage 3 breast cancer, are ER+ and/or PR+, and HER2-, and who have undergone surgery. Half of all participants will take palbociclib orally for 21 days, then have 7 days off, repeating for two years, as well as standard endocrine therapy. The other half will just have standard endocrine therapy.

    This trial is recruiting in a number of places across Australia. View the full trial description, and if you're interested, contact Monica Bertagnolli (PALLAS@anzbctg.org)

  • PENELOPE-B (Recruiting)

    Updated: October 29th, 2016

    This phase 3 PENELOPE-B study is designed to demonstrate that in the background of standard anti-hormonal therapy, palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre- and postmenopausal women with HR+/HER2-normal early breast cancer at high risk of relapse after showing less than pathological complete response to neoadjuvant taxane - containing chemotherapy. Considering the high risk of recurrence in patients after neoadjuvant chemotherapy and a high CPS-EG score, palbociclib appears to be an attractive option with a favourable safety profile for these patients.

    Run by: German Breast Group at various locations in Victoria, Australia - View full trial description and contact details.

  • Letrozole with BYL719 (Recruiting)

    Updated: November 29th, 2016

    The purpose of the study is to determine whether treatment with a PI3K inhibitor plus letrozole leads to an increase in pathologic clinical response and Objective Response Rate compared to treatment with placebo plus letrozole in patients with breast cancer.

    View the full trial description and contact details.

  • APBI Study (Recruiting)

    Updated: February 24th, 2016

    This study is evaluating the feasibility of accelerated partial breast irradiation (APBI) in women with breast cancer. You may be eligible to join this study if you are a woman above 50 years of age who has been diagnosed with early or local breast cancer.

    All participants in this study will undergo a procedure called accelerated partial breast irradiation (APBI). This involves the insertion of approximately 10 to 25 hollow plastic tubes (catheters) into the region surrounding the surgical excision cavity of the breast under general anaesthetic. These catheters will remain in situ for 7 days. The catheters are then connected to a computerised machine which remotely loads a high dose rate radioactive source into the catheters and determines the amount of time that the source remains in each specific dwell position. In doing so, the dose of radiation is individually tailored to target the areas which are at the highest risk of disease recurrence whilst minimising dose to the surrounding normal structures such as the lungs, heart and contralateral breast. Treatment is delivered twice daily over 5 days in total with the catheters. Each treatment will take 10-15 minutes with an inter-fraction interval of at least 6 hours.

    Run by: Dr Yaw Chin at St George Public Hospital, NSW - View full trial description and contact details.

  • POSITIVE (Recruiting)

    Updated: December 30th, 2016

    The best available evidence suggests that pregnancy after breast cancer does not increase a woman's risk of developing a recurrence from her breast cancer, even if her cancer is endocrine-receptor positive. There is also no indication of increased risk for delivery complications or for the newborn.

    This study is for women with ER+ breast cancer who want to interrupt endocrine therapy in order to become pregnant. The aim of the study is to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of breast cancer recurrence. A psycho-oncological companion study on fertility concerns, psychological well-being and decisional conflicts will be conducted in interested centers.

    View full trial description and contact details.


bridget.robinson@cdhb.health.nz
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