At BCRC-WA, our dedicated Breast Clinical Trials Unit (BCTU) performs many clinical trials including those designed to evaluate new treatments versus current (approved) treatments, evaluate approved treatments in new settings, evaluate ways of reducing side effects of treatment, expand the understanding of the biological behavior of breast cancer and investigate the social and emotional impact of breast cancer on patients and their families.
Early Breast Cancer
EMBER-4
Status:
Active – Recruiting
Title:
EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence
Trial ID
Type
Adjuvant
Cancer Type
Hormone positive
For full inclusion / exclusion criteria you can visit the Australian Cancer Clinical Trials Registry
GLORIA
Status:
Active – Recruiting
Title:
The GLORIA Study: A Phase 3, Randomized, Open-Label Study of the Anti-Globo H Vaccine Adagloxad Simolenin (OBI 822)/OBI 821 in the Adjuvant Treatment of Patients with High Risk, Early- Stage Globo H-Positive Triple Negative Breast Cancer
Trial ID
Type
Adjuvant
Cancer Type
H-Positive Triple Negative Breast Cancer
For full inclusion / exclusion criteria you can visit the Australian Cancer Clinical Trials Registry
Metastatic Breast Cancer
ASCENT-03
Status:
Active – Recruiting
Title:
A Randomized, Open-Label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated with Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1.
Trial ID
Type
1st Line
Cancer Type
Triple Negative
For full inclusion / exclusion criteria you can visit the Australian Cancer Clinical Trials Registry
ASCENT-07
Status:
Active – Recruiting
Title:
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2−) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH−]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy
Trial ID
Type
Patients must have received prior hormone therapy with or without CDK 4/6 inhibitor but no prior chemotherapy in the advanced or locally advanced setting
Cancer Type
HR+/HER2-
HER2CLIMB-02
Status:
Active – Not recruiting
Title:
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)
Trial ID
Type
Cancer Type
HR+/HER2-
For full inclusion / exclusion criteria you can visit the EU Clinical Trials Registry
JSKN003
Status:
Active – Not Recruiting
Title:
JSKN003-101: A Phase I, Multi-center, Open-label, Dose Escalation, First-In-Human Study to Assess the Safety, Tolerability and Pharmacokinetics of JSKN003 in Subjects with Advanced or Metastatic Solid Malignant Tumors.
Trial ID
Type
> 2nd Line
Cancer Type
HER2 ≥ 1 Positive
Olema-02
Status:
Active – Not Recruiting
Title:
A Phase 1 Dose Escalation and Dose Expansion Open-label, Multicenter, Study of OP-1250 in Combination with the CDK4/6 Inhibitor Palbociclib in Adult Subjects with Advanced or Metastatic HR-positive, HER2-negative Breast Cancer.
Trial ID
Type
> 1st Line
Cancer Type
HR Positive, HER2 Negative
For full inclusion / exclusion criteria you can visit the Australian Cancer Clinical Trials Registry
OP3
Status:
Active – Recruiting
Title:
A Phase 1b Open-Label Multicenter Study of OP-1250 in Combination with the CDK4/6 Inhibitor Ribociclib or with the PI3K Inhibitor Alpelisib in Adult Subjects with Advanced and/or Metastatic HR Positive, HER2 Negative Breast Cancer.
Trial ID
Type
1st to 3rd Line
Cancer Type
HR Positive, HER2 Negative
For full inclusion / exclusion criteria you can visit the Australian Cancer Clinical Trials Registry
OPERA-01
Status:
Active – Recruiting
Title:
A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)
Trial ID
Type
2nd or 3rd line
Cancer Type
ER positive, HER2 negative
For full inclusion / exclusion criteria you can visit the Australian Cancer Clinical Trials Registry
PATINA
Status:
Active – Not Recruiting
Title:
A Randomized, 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
Trial ID
Cancer Type
HER2 Positive, Hormone Receptor Positive
For more information visit the EU Clinical Trials Register
TTAC_06
Status:
Active – Recruiting
Title:
A Phase II, Open-Label, Multicenter Study of Olinvacimab in Combination with Pembrolizumab in Patients with Metastatic Triple-Negative Breast Cancer.
Trial ID
Type
2nd Line
Cancer Type
Triple Negative Breast Cancer
For full inclusion / exclusion criteria you can visit the Australian Cancer Clinical Trials Registry
VIKTORIA-1
Status:
Active – Recruiting
Title:
A Phase 3, Open-Label, Randomized, Two-Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard-of-Care Therapies in Patients with HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy (VIKTORIA-1).
Trial ID
Type
2nd Line
Cancer Type
HR Positive, HER2 Negative
For full inclusion / exclusion criteria you can visit the Australian Cancer Clinical Trials Registry
Referrals
If you would like to be considered for a clinical trial you will require a referral from your current treating team. Visit our referrals page for referral information.
For more information on clinical trials, get in contact with our Breast Clinical Trial Unit:
Breast Clinical Trials Unit (BCTU)
Business hours, Mon to Friday between 9am – 5pm
Email: BCTU@bcrc-wa.com.au
Phone: (08) 6500 5575
This page was updated in March 2024