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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

DESTINY-05

Status:

Active – Recruiting

Title:

A phase 3, multicenter, randomized, open-label, active-controlled study of trastuzumab deruxtecan (t-dxd) versus trastuzumab emtansine (t-dm1) in subjects with high-risk her2-positive primary breast cancer who have residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy.

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

JSKN003

Status:

Active – 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 – 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

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

 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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