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

Sponsor
Canadian Cancer Trials Group
Study ID
NCT05601440
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • RP-6306 — DRUG
    Dose and schedule will be assigned at enrolment
  • Gemcitabine — DRUG
    Dose and schedule will be assigned at enrolment
  • Observation — OTHER
    Monitoring arm
  • Niraparib — DRUG
    Dose and schedule will be assigned at enrolment
  • Fulvestrant — DRUG
    Dose and schedule will be assigned at enrolment
  • RP-3500 — DRUG
    Dose and schedule will be assigned at enrolment
  • CFI-402257 — DRUG
    Dose and schedule will be assigned at enrolment
  • CFI-400945 — DRUG
    Dose and schedule will be assigned at enrolment
  • Sacituzumab govitecan — DRUG
    Dose and schedule will be assigned at enrolment

Study Details

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

Key Dates

Start date
Jun 13, 2023
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
484 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Substudy A - Monitoring
  • Experimental: Substudy B - RP-6306 + Gemcitabine - Arm Permanently Closed
  • Experimental: Substudy C - Niraparib + Fulvestrant
  • Experimental: Substudy D - RP-6306 + RP-3500 - Arm Permanently Closed
  • Experimental: Substudy E - CFI-402257
  • Experimental: Substudy F - CFI-400945
  • Experimental: Substudy G - Sacituzumab Govitecan

Primary Outcome Measure

Evaluate whether biomarker selection improves outcomes as assessed by RECIST 1.1 for overall response rate [ Time Frame: 5 years ]

Central Contacts

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