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Rash & Diarrhea Prophylaxis With Capivasertib

Study acronym: SAFE-CAP
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Recruitment opened
    • Start date: Apr 2026 to Aug 15, 2026
    • Site details revised
    v3
  2. Primary endpoints revised (2)
    • Secondary endpoints revised (8)
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a randomized, multicenter, phase II clinical trial evaluating prophylactic strategies to mitigate common toxicities associated with capivasertib in combination with fulvestrant in participants with hormone receptor-positive (HR+), HER2-negative advanced breast cancer who are eligible for this treatment regimen.
Trial Details
NCT Number NCT07426822
Lead Sponsor Maryam Lustberg
Collaborators: AstraZeneca
Conditions
(from sponsor)		 Metastatic HR+/HER2- Breast Cancer
Related terms Diarrhea, Exanthema
Enrollment 108 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov