Liquid Biopsy-Informed Therapy for Breast Cancer
Trial Summary
What is the purpose of this trial?
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
Will I have to stop taking my current medications?
The trial protocol does not clearly specify if you must stop taking your current medications. However, it mentions that certain medications are not permitted during the study, and there is a washout period (time without taking certain medications) required for some prior therapies. It's best to discuss your specific medications with the trial coordinators.
Is the treatment generally safe for humans?
What makes the drug combination of Fulvestrant, Gemcitabine, Niraparib, and RP-6306 unique for breast cancer treatment?
This drug combination is unique because it uses a liquid biopsy to inform therapy, potentially allowing for more personalized treatment. Additionally, it combines Fulvestrant, a hormone therapy, with Niraparib, a PARP inhibitor, and other agents, which may offer a novel approach compared to standard treatments that typically do not use this combination.12678
Research Team
David Cescon
Principal Investigator
University Health Network, Princess Margaret Hospital, Toronto ON Canada
Nathalie Levasseur
Principal Investigator
BCCA - Vancouver Cancer Centre
Stephen Chia
Principal Investigator
BCCA - Vancouver Cancer Centre
John Hilton
Principal Investigator
Ottawa Hospital Research Institute
Moira Rushton
Principal Investigator
Ottawa Hospital Research Institute
Eligibility Criteria
This trial is for adults with ER+/HER2- metastatic breast cancer that has worsened after CDK4/6 inhibitor therapy. Participants must have a life expectancy of at least 3 months, be able to receive treatment and follow-up at the center, and not have had certain treatments or conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive investigational drugs/drug combinations based on biomarker testing
Monitoring
Participants are monitored for progression and molecular changes in CDK4/6i resistance
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- CFI-400945
- CFI-402257
- Fulvestrant
- Gemcitabine
- Niraparib
- Observation
- RP-6306
Fulvestrant is already approved in European Union, United States, Canada, Japan for the following indications:
- Hormone receptor-positive metastatic breast cancer
- Locally advanced breast cancer
- Hormone receptor-positive metastatic breast cancer
- Locally advanced breast cancer
- Hormone receptor-positive metastatic breast cancer
- Locally advanced breast cancer
- Hormone receptor-positive metastatic breast cancer
- Locally advanced breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Canadian Cancer Trials Group
Lead Sponsor