Clinical trials are research studies in which new treatments are tested against current standard treatments. They involve patients taking new drugs or undergoing new treatments to see whether these are effective in combating disease.
There are numerous breast cancer clinical trials currently underway throughout New Zealand and the rest of the world. These aim to identify new and more effective ways of treating breast cancer or ways of preventing it from occurring.
On this page you can find out more about how clinical trials work and the clinical trials that are currently underway in New Zealand. To find out more about the latest international research, check out our research news.
How does a clinical trial work?
Research nurse Jenni Scarlet tells us more about clinical trials,the different types of trials, reasons for participating and trial protocols.
Why participate in a clinical trial?
Breast cancer survivor Raewyn Calvert has been involved in a clinical trial and talks about reasons to participate in breast cancer research.
Breast Cancer Trials
Breast Cancer Trials is a group of world-leading breast cancer doctors and researchers based in Australia and New Zealand. The group has been conducting clinical trials research for the treatment and prevention of breast cancer in Australia and New Zealand for 40 years. Find out more about some of the ground-breaking outcomes of their research.
Current Clinical Trials
This international trial is looking at whether a new way of delivering lidocaine, a commonly used local anaesthetic drug, will help reduce the occurrence of moderate or severe chronic post-surgical pain for women undergoing breast cancer surgery. Waikato, Auckland and Middlemore Hospitals are the New Zealand trial sites, although Middlemore has not yet started recruiting.
This clinical trial is investigating the efficacy and safety of adjuvant atezolizumab (Tecentriq) or placebo and trastuzumab emtansine (Kadcyla) for HER2-positive breast cancer at high risk of recurrence following preoperative therapy. New Zealand sites for this trials are: Auckland City Hospital and Tauranga Hospital (now closed - no longer recruiting).
This is a randomised phase III trial of adjuvant radiation therapy versus observation following breast conserving surgery and endocrine therapy in patients with molecularly characterised luminal A early breast cancer. The purpose of this study is to see whether a specialised laboratory test (Prosigna (PAM50) Assay) of breast cancer tissue can be used to choose women who can safely avoid radiation therapy because there is a low risk of the cancer coming back. New Zealand sites are Waikato Hospital, Christchurch Hospital, Wellington Hospital and Palmerston North Hospital.
A phase III, open, randomised, multicentre trial comparing standard axillary treatment (either axillary lymph node dissection (ALND) or axillary radiotherapy (ART)) with no axillary treatment post-surgery, in early stage (T1-3N1M0) breast cancer patients. The only New Zealand trial site is Wellington Hospital.
ctDNA Breast Study
This is an in-house study at Christchurch Hospital collecting ctDNA alongside clinical care. Circulating tumour DNA (ctDNA) is DNA released by a tumour into the bloodstream; it can be detected in a blood test to provide information about the state of a person's cancer. In breast cancer, it is used mainly in research or in clinical trials, but it will likely be used in routine clinical practice once certain issues have been worked out and methods of analysis have been improved and standardized.
The purpose of this study is to see whether a specialised laboratory test (Prosigna (PAM50) Assay) of breast cancer tissue can be used to choose women with early ER-positive HER2-negative breast cancer who can safely avoid chemotherapy because there is a low risk of the cancer coming back. New Zealand sites will be Waikato Hospital (lead site), Tauranga Hospital, Wellington Hospital and Palmerston North Hospital.
Cambria-2 (pending activation)
This is a Phase II open-label study to assess the efficacy and safety of camizestrant (a next-generation oral selective oestrogen receptor degrader - SERD) compared to standard endocrine therapy (aromatase inhibitor or tamoxifen) for patients with early ER-positive HER2-negative breast cancer and an intermediate-to-high or high risk of recurrence and who have completed definitive locoregional treatment and have no evidence of disease. New Zealand trial sites will be Auckland Hospital, Waikato Hospital and Palmerston North Hospital.
This is a Phase III, randomized, open-label multicentre study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with ER-positive HER2-negative advanced breast cancer who have developed resistance to adjuvant endocrine therapy. New Zealand trial sites are Palmerston North (now recruiting - July 2024), a second North Island site (not yet recruiting) and potentially a South Island site as well.
INAVO120 Trial (recruiting completed, trial participants in follow-up)
This study aims to evaluate the efficacy and safety of Inavolisib in combination with palbociclib and fulvestrant in patients with PIK3CA-mutant, hormone receptor positive, HER2-negative, locally advanced or metastatic breast cancer. Palmerston North Hospital was the only New Zealand site for this trial.
FINER Trial (recruitment completed, trial participants in follow-up)
This clinical trial aims to find out if a new drug, ipatasertib (an AKT inhibitor) can slow the growth of advanced ER-positive, HER2-negative breast cancer when added to standard therapy (fulvestrant). New Zealand sites for this trial are: Auckland City Hospital and Wellington Hospital.
NeoN Trial (recruitment closed and in follow-up)
The NeoN trial is coordinated through Breast Cancer Trials and investigates if using an immunotherapy drug alone prior to the combination of immunotherapy and standard chemotherapy is safe and effective in treating breast cancer before surgery. This trial was open to both women and men diagnosed with unilateral triple negative early breast cancer. Early results from this trial were announced in December 2023; read more here. Waikato Hospital is the New Zealand site for this trial. In April 2024, NZ researchers reported that they were waiting for the 3rd arm of this trial to open, so potentially there could be more recruitment to this trial.
STARS Trial (active but not currently recruiting)
This clinical trial compares the order of treatments for women who have oestrogen and/or progesterone receptor positive breast cancer and need both radiation treatment and hormone medication (anastrozole) to control the breast cancer following surgery. In New Zealand the trial is open in Auckland, Palmerston North and Christchurch.
PersevERA Trial (recruitment completed, trial participants in follow-up)
This clinical trial is investigating the efficacy and safety of GDC-9545 combined with palbociclib compared with Letrozole combined with palbociclib in patients with oestrogen receptor positive, HER2-negative, locally advanced or metastatic breast cancer. New Zealand sites for this trial are Auckland City Hospital and Waikato Hospital.
POSNOC Trial (recruitment completed, trial participants in follow-up)
POSNOC - POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus axillary clearance or axillary radiotherapy. A randomised controlled trial of axillary treatment in women with early stage breast cancer who have metastases in one or two sentinel nodes.
This phase II, pragmatic, randomised controlled trial will compare lymph node grafting, in addition to standard lymphoedema therapy; against standard lymphoedema therapy alone. Study participants will be those with residual stage one to two breast-cancer related lymphoedema, despite initial treatment with standard lymphoedema therapy.
PATINA Trial (active, but not recuiting)
This is a randomised, open label, Phase III Trial to evaluate the efficacy and safety of palbociclib + anti-HER2 therapy + endocrine therapy vs. anti-HER2 therapy + endocrine therapy after induction treatment for hormone receptor positive (HR+)/HER2-positive metastatic breast cancer. It is open to people diagnosed with hormone receptor (HR) positive, Human Epidermal Growth Factor Receptor 2 (HER-2) positive metastatic breast cancer.
MonarchE Trial (recruitment closed and in follow-up)
A randomised, open label, Phase III study of abemaciclib combined with standard adjuvant endocrine therapy alone in patients with high risk, node positive, early stage, hormone receptor positive, HER2 negative breast cancer. The aim of this study, MonarchE, is to evaluate whether the combination of abemaciclib plus standard adjuvant endocrine therapy improves outcomes in participants with a certain type of breast cancer compared to adjuvant endocrine therapy alone. This study is now closed; no new patients will be recruited but those already in the study will continue to be followed up. Results published so far have shown that adding abemaciclib to endocrine therapy significantly reduces the risk of recurrence in these patients.
IBCSG 24-02/BIG 2-02: SOFT (recruitment closed and in follow-up)
Suppression of Ovarian Function Trial. A phase III trial evaluating the role of ovarian function suppression and the role of exemestane as adjuvant therapies for premenopausal women with endocrine responsive breast cancer. New Zealand sites are Waikato Hospital, Christchurch Hospital, Palmerston North Hospital and Auckland Hospital.
SNAC-2 Trial (closed, results being analysed)
This trial, which began in 2006, has compared two operations for detecting cancer cells in the lymph nodes of women with early breast cancer - sentinal node biopsy versus auxillary clearance. It followed on from an earlier trial, SNAC-1, and aimed to extend its findings by recruiting women with larger tumours and multiple tumours. A fact sheet about the SNAC trials can be seen here. SNAC-2 follow-up was completed in January 2023 and analysis of the results is currently under way.
TROG Trial (recruitment closed and in follow-up)
This trial was for women who have ductal carcinoma in situ (DCIS) of the breast. It aimed to see whether improvements could be made to radiation treatment after surgery by giving women an extra treatment 'boost' dose, and also whether a shorter course of whole breast irradiation was as effective as a long one. In a recent study summary, the researchers concluded that the boost treatment reduced the risk of recurrence and that the shorter course of whole breast irradiation (16 treatments) was as effective as the longer course. A final analysis of all results is planned for 2024.
Will an adapted Mediterranean diet (BC-MED) improve health in breast cancer survivors? (completed)
This trial investigated whether an adapted Mediterranean diet improves health outcomes for women who have been treated for early stage breast cancer. Study participants were divided into three groups: one group followed an adapted Mediterranean diet, another followed a low-fat diet, and the third (control) group ate their normal diet. Compared to the control group, both the 'diet' groups lost weight, with significant decreases in body mass index (BMI) and waist circumference, and had improved blood biomarkers, such as blood lipids and blood glucose. Both diet groups showed satisfactory adherence to their diets. The researchers concluded that nutritional education and group support appears to exert beneficial effects on health in breast cancer survivors; of lesser importance is the type of diet that forms the basis of the education.
The published results of this study can be seen here.
PantoCIN (early breast cancer trial for ER+) (completed)
The PantoCIN trial aimed to test the ability of a cheap, widely available drug to prevent two of chemotherapy's most unpleasant side-effects: delayed nausea and vomiting. These can occur after breast cancer chemotherapy, affecting the quality of life. A potential cause of these delayed side effects is that the chemotherapy may cause stomach irritation. Pantoprazole is commonly used to treat stomach irritation by reducing stomach acid, which may, in turn, improve nausea and/or vomiting. This study has explored whether this medication can help prevent these side effects from chemotherapy for early breast cancer. This trial has now been completed and has shown that pantoprazole is an effective treatment. Find out more.
Hot Flush Trial - Phase II (completed)
QUE Oncology has completed a Phase II trial at several sites in New Zealand for its novel non-hormonal therapy for women with breast cancer suffering hot flushes and night sweats. After a breast cancer diagnosis, women are routinely prescribed drugs such as tamoxifen or aromatase inhibitors (known as endocrine therapy) for up to 10 years post-diagnosis. These drugs are known to reduce the recurrence of breast cancer by reducing or blocking the action of estrogen, a hormone known to stimulate the growth of breast cancer. However, the most common side-effect of reducing estrogen is an increased likelihood of hot flushes and night sweats. These symptoms can severely impact a woman's quality of life and often cause them to stop taking their breast cancer treatment. QUE Oncology is looking to develop a therapy to address these symptoms. Find out more about the trial here.
The final results of MARIANNE were published in 2019. They showed that trastuzumab emtansine (T-DM1) with or without pertuzumab showed noninferior progression-free survival and better tolerability than trastuzumab plus a taxane for the treatment of HER2-positive advanced breast cancer. The researchers concluded that the results supported the use of trastuzumab emtansine as a first-line treatment for patients with HER2-positive metastatic breast cancer who are deemed unsuitable for taxane-based therapy.
