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Open Clinical Trials

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

 NCT05514054

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

 NCT03562637

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

 NCT05382299

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

NCT05840211

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

NCT03975647

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

 NCT05494918

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

 NCT05266105

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

 NCT05508906

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

NCT06016738

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

NCT02947685

Cancer Type

HER2 Positive, Hormone Receptor Positive

For more information visit the EU Clinical Trials Register

TTAC_06

Status:

Active – Not 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

 NCT04986852

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

 NCT05501886

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.

Download Referral Form

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

Glossary of terms

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This page was updated in March 2024