Clinical Trial

Cyclin dEpendent Kinase in tRiple nEGatIVe brEast canceR - a "Window of Opportunity" Study

Study acronym: CAREGIVER
Not Yet Recruiting Phase 2
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Record status
This record was last updated October 5, 2021 (before its estimated January 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
CAREGIVER is a prospective, randomized, multicenter, open, five-arm study with unequal allocation ratios of 1:1:2:1:2 (palbociclib : paclitaxel : palbociclib + paclitaxel : carboplatin : carboplatin + paclitaxel). Study will be performed in untreated patients with triple-negative breast cancer (TNBC). Potential candidates without previously established diagnosis of TNBC will be included in a Pre-screening Phase, when a biopsy of breast tumor will be taken to confirm the diagnosis of cancer, select patients with TNBC and collect tissue for translational research.
Trial Details
NCT Number NCT05067530
Lead Sponsor Medical University of Gdansk
Conditions Triple Negative Breast Neoplasms
Enrollment 126 participants
Start Date 2022-01-01
Primary Completion 2025-01-01 (estimated)
Study Completion 2026-12-06 (estimated)
Updated on ClinicalTrials.gov 2021-10-05