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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv24
  2. Interventions: Fulvestrant (Drug), Gemcitabine (Drug), Niraparib (Drug), Observation (Other), RP-3500 (Drug), RP-6306 (Drug) to CFI-400945 (Drug), CFI-402257 (Drug), Fulvestrant (Drug), Gemcitabine (Drug), Niraparib (Drug), Observation (Other), RP-3500 (Drug)…
    • Eligibility criteria expanded, about 90 words
    • Study description shortened, about 9 words
    • Study arms: 4 to 7
    v23
  3. 3 versions Re-verified since Jan 29, 2026, no change to tracked fieldsv20-v22
  4. Study sites revised (10)v19
  5. 2 versions Re-verified since Dec 9, 2024, no change to tracked fieldsv17-v18
Show 15 earlier versionsHide 15 earlier versions
  1. Interventions: Fulvestrant (Drug), Gemcitabine (Drug), Niraparib (Drug), Observation (Other), RP-6306 (Drug) to Fulvestrant (Drug), Gemcitabine (Drug), Niraparib (Drug), Observation (Other), RP-3500 (Drug), RP-6306 (Drug)
    • Eligibility criteria expanded, about 137 words
    • Study arms: 3 to 4
    v16
  2. Study sites: 9 to 10v15
  3. Study sites: 8 to 9v14
  4. Study sites: 6 to 8v13
  5. Primary completion date: Dec 2027 to Dec 31, 2027
    • Study completion date: Jun 2028 to Jun 30, 2028
    v12
  6. Study sites: 5 to 6v11
  7. Start date: Jan 27, 2023 to Jun 13, 2023v10
  8. Study sites: 4 to 5v9
  9. Study sites: 3 to 4v8
  10. Study sites: 1 to 3v7
  11. Interventions: CFI-400945 (Drug), CFI-402257 (Drug), Fulvestrant (Drug), Gemcitabine (Drug), Niraparib (Drug), Observation (Other), RP-6306 (Drug) to Fulvestrant (Drug), Gemcitabine (Drug), Niraparib (Drug), Observation (Other), RP-6306 (Drug)
    • Study arms: 5 to 3
    v6
  12. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 2023 to Jan 27, 2023
    v5
  13. Interventions: Gemcitabine (Drug), Observation (Other), RP-6306 (Drug) to CFI-400945 (Drug), CFI-402257 (Drug), Fulvestrant (Drug), Gemcitabine (Drug), Niraparib (Drug), Observation (Other), RP-6306 (Drug)
    • Eligibility criteria revised
    • Study arms: 2 to 5
    v4
  14. Start date: Dec 2022 to Jan 2023v3
  15. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Number NCT05601440
Lead Sponsor Canadian Cancer Trials Group
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 484 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov