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

NCT05601440 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 484

Last updated 2026-05-07

No results posted yet for this study

Summary

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

Interventions

DRUG

RP-6306

Dose and schedule will be assigned at enrolment

DRUG

Gemcitabine

Dose and schedule will be assigned at enrolment

OTHER

Observation

Monitoring arm

DRUG

Niraparib

Dose and schedule will be assigned at enrolment

DRUG

Fulvestrant

Dose and schedule will be assigned at enrolment

DRUG

RP-3500

Dose and schedule will be assigned at enrolment

DRUG

CFI-402257

Dose and schedule will be assigned at enrolment

DRUG

CFI-400945

Dose and schedule will be assigned at enrolment

DRUG

Sacituzumab govitecan

Dose and schedule will be assigned at enrolment

Sponsors & Collaborators

  • Canadian Cancer Trials Group

    lead NETWORK

Principal Investigators

  • David Cescon · University Health Network, Princess Margaret Hospital, Toronto ON Canada

  • John Hilton · Ottawa Hospital Research Institute

  • Nathalie Levasseur · BCCA - Vancouver Cancer Centre

  • Stephen Chia · BCCA - Vancouver Cancer Centre

  • Moira Rushton · Ottawa Hospital Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-13
Primary Completion
2027-12-31
Completion
2028-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05601440 on ClinicalTrials.gov