Actively Recruiting
Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer
Led by Canadian Cancer Trials Group · Updated on 2026-05-07
484
Participants Needed
10
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced/metastatic breast cancer with ER >10% and not HER2 overexpressing/amplified
- Availability of formalin fixed paraffin embedded tissue block from primary or metastatic tumor
- Objective disease progression on or within 8 weeks of last dose of first line CDK4/6 inhibitor plus endocrine therapy, with at least 24 weeks of such therapy
- Clinically and/or radiologically documented disease with measurable lesions per RECIST 1.1
- Age 18 years or older
- ECOG performance status 0 or 1
- Life expectancy of at least 3 months
- Hemoglobin ≥90 g/L
- Absolute neutrophils ≥1.5 x 10^9/L
- Platelets ≥100 x 10^9/L
- Bilirubin ≤1.5 x upper limit of normal
- AST and ALT ≤2.5 x upper limit of normal, or ≤5 x ULN if liver metastases present
- Serum creatinine ≤1.5 x upper limit of normal, creatinine clearance ≥50 mL/min
- Prior treatments allowed as specified, including certain endocrine therapies and targeted agents
- No recent transfusions or colony stimulating factors within 4 weeks prior to study treatment
- At least 28 days since major surgery or radiation therapy
- Consent for blood sample collection and study participation
- Accessibility for treatment and follow-up at study center
- Women/men of childbearing potential must agree to use highly effective contraception
You will not qualify if you...
- History of other malignancies except certain treated cancers without evidence of disease for at least 2 years
- Active or uncontrolled infections including HIV with detectable viral load, hepatitis B or C, or pneumonitis requiring steroids
- Receipt of live attenuated vaccine within 30 days before study therapy
- Known primary immunodeficiency
- Recent significant cardiac disease or heart failure
- Left ventricular ejection fraction below 50%
- HER2 positive breast cancer
- Hypersensitivity to study drugs
- Concurrent anti-cancer therapies apart from stable bone-targeted therapy
- Prior allogenic bone marrow or double umbilical cord blood transplant
- Pregnant or breastfeeding women
- History of untreated or unstable central nervous system metastases
- Inability to swallow oral medications or significant gastrointestinal disorders affecting drug absorption unless approved
- History of non-compliance with medical regimens
- Use of certain prohibited medications
- Caution advised with oral anticoagulants; warfarin use should be avoided if history of thrombosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
2
BCCA - Kelowna
Kelowna, British Columbia, Canada, V1Y 5L3
Actively Recruiting
3
BCCA - Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
4
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Actively Recruiting
5
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Actively Recruiting
6
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Actively Recruiting
7
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
8
Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Suspended
9
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
10
The Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
Research Team
L
Lesley Seymour
CONTACT
L
Laura Pearce
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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