NCT05067530

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Medical University of Gdansk · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Triple Negative Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Palbociclib	CDK4/6 inhibitor
DRUG	Paclitaxel	Chemotherapy
DRUG	Carboplatin	Chemotherapy

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-01-01
• Completion: 2026-12-06
• First posted: 2021-10-05
• Last updated: 2021-10-05

Locations

6 sites across 1 country: Poland