Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer

This study is being done to answer the following question: Can testing breast cancer for DNA abnormalities or "biomarkers" help predict which patients are most likely to be helped by certain treatments? The pre-study screening is being done to test a sample of blood (or tumour tissue) for biomarkers to see if patients can participate in the study

Trial Details

NCT ID

NCT05601440

Phase

PHASE2

Sponsor

Canadian Cancer Trials Group

Status

RECRUITING

Cancer Type

Breast Cancer

Interventions

RP-6306
Gemcitabine
Observation
Niraparib
Fulvestrant
RP-3500

Locations (sample)

Calgary, Alberta, Canada|51.05011,-114.08529
Kelowna, British Columbia, Canada|49.88307,-119.48568
Vancouver, British Columbia, Canada|49.24966,-123.11934
Halifax, Nova Scotia, Canada|44.64269,-63.57688
Hamilton, Ontario, Canada|43.25011,-79.84963

Key Eligibility Criteria

Patients must have histologically and/or cytologically confirmed, advanced / metastatic breast cancer, ER \>10% and not HER2 overexpressing/amplifi…
All patients must have a formalin fixed paraffin embedded tissue block (from primary or metastatic tumour) available and must have provided informe…
Patients must have had objective disease progression demonstrated on (defined as while taking or within 8 weeks of the last dose) first line CDK4/6…
Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 21 days prior to enrollment (within…

For full eligibility, visit ClinicalTrials.gov.

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