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CLOVER: 4 vs 6 Cycles of TC Adjuvant Chemotherapy for Early Breast Cancer
NCT03926091Phase 3
Key facts
- Status
- Unknown
- Start
- Apr 2019
- Primary completion
- Nov 2024
- Countries
- 1
- Sponsor
- Fudan University
- Modality
- Small Molecules
- Conditions
- breast cancer
01
Overview
Phase 3, randomised, open-label trial of docetaxel and cyclophosphamide in breast cancer (2 arms), sponsored by Fudan University. Primary endpoint: Invasive Disease Free Survival at 5 years. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
4 cycles of TC adjuvant chemotherapy
4 cycles of TC (Docetaxel 75 mg/m^2 ivgtt d1+Cyclophosphamide 600 mg/m^2 iv d1, 21 days per cycle).
6 cycles of TC adjuvant chemotherapy
6 cycles of TC (Docetaxel 75 mg/m^2 ivgtt d1+Cyclophosphamide 600 mg/m^2 iv d1, 21 days per cycle).
03
Who it enrols
Women aged 18-70 with localized invasive ER+/HER2- breast cancer with 1-3 positive lymph nodes, meeting specific risk criteria (e.g., grade III, high Ki67, low PR, age <35, high RS), adequate organ function, and no prior neoadjuvant therapy.
04
Endpoints
Primary
Invasive Disease Free Survival
Secondary
Disease Free Survival
Distant Disease Free Survival
Overall Survival
Adverse Effects
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