Clinical Trials

Clinical trials provide opportunities to investigate possible new treatments for breast cancer and supportive care. Dr Forster can provide more information on clinical trials and discuss whether this is an option for you.

Why do we have clinical trials?

Clinical trials are necessary to investigate if new treatments for breast cancer or supportive care are more effective than existing treatments that are already established as the standard of care. 

Dr Ben Forster is an active member of Breast Cancer Trials (formerly the ANZBCTG) and has been a principal investigator or sub-investigator for many trials, including trials run by BCT and pharmaceutical sponsored trials.

Should I participate in a breast cancer clinical trial?

People choose to participate in clinical trials for many reasons. Some of the main reasons include:

• Being able to access new treatments before they are available as standard treatment in Australia.

• Wanting to contribute to research to advance the understanding of breast cancer and improve outcomes which can be gratifying and rewarding.

• Being more closely monitored than people who receive standard treatment (even if they are not receiving the new intervention or treatment being studied) which can sometimes lead to better outcomes.

There can be downsides to participating in clinical trials, including the need for more frequent investigations, medical appointments or less flexible treatment logistics, so they are not for everyone.

If you would like more information about the benefits of clinical trials in breast cancer, please visit Breast Cancer Trials for more information.

Current trials at the Patricia Ritchie Centre

The following clinical trials are open for accrual at the Patricia Ritchie Centre, Mater Hospital, North Sydney:

• BCT 1901 (CAPTURE): A phase II randomised study to evaluate alpelisib plus fulvestrant versus capecitabine in oestrogen receptor positive, HER2-negative advanced breast cancer patients with PIK3CA mutant circulating DNA.

• A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)

• Efficacy Comparison of Niraparib to Placebo in Participants with HER2-Neg BRCAmut or Triple-Negative Breast Cancer with Molecular Disease Based on Presence of ctDNA

• De-escalation Adjuvant Chemo in HER2+/ER-/Node-neg Early BC Patients Who Achieved pCR After Neoadjuvant Chemo & Dual HER2 Blockade (Decrescendo)

• Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer (ASCENT-03)

• Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer (ASCENT-04)

Trials coming soon

Trials closed for accrual (in follow up)

• A Randomized, Multicentre, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in the Treatment of High-risk, Oestrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer (CheckMate 7FL)

• Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Subjects With Unresectable Locally-advanced or Metastatic HER2+ Breast Cancer (HER2CLIMB-02)

• WO42312 ACELERA: A Phase Ii, Randomized, Open-Label, Multicenter Study Evaluating The  Efficacy And Safety Of GDC-9545 Compared With Physician's Choice Of Endocrine Monotherapy In Patients With Previously Treated ER+ , Her2-Negative Locally Advanced Or Metastatic Breast Cancer

• CAPItello-291: A Phase III Double-blind Randomised Study Assessing the Efficacy and  Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as  Treatment for Locally Advanced (Inoperable) or Metastatic Hormone  Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative  (HR+/HER2−) Breast Cancer Following Recurrence or Progression On or  After Treatment with an Aromatase Inhibitor

• BCT 1702 (CHARIOT): A phase II study evaluating efficacy and safety of Ipilimumab and Nivolumab with neoadjuvant weekly paclitaxel after anthracycline based chemotherapy in high-risk primary triple negative breast cancer, followed by definitive surgery and one year total duration of Nivolumab

• Roche WO40181 study - A Phase II Study Comparing The Efficacy Of Venetoclax + Fulvestrant Vs. Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy

• monarchE - A Study to Compare Treatment After Surgery of Abemaciclib (LY2835219) Combined With Standard Endocrine Therapy Versus Endocrine Therapy Alone in Participants With Breast Cancer

• A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer

• HER2CLIMB - Phase 2 Study of Tucatinib vs Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer

• Cognitive rehabilitation for breast cancer survivors with perceived cognitive impairment

If you are receiving treatment for breast cancer, discuss with your medical team if a participating in a clinical trial is an option for you.