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CONCEPT: Capecitabine and Aromatase Inhibitor in HR+ Metastatic Breast Cancer
NCT04012918Phase 2
Key facts
- Status
- Unknown
- Start
- Aug 2018
- Primary completion
- Aug 2020
- Countries
- 1
- Sponsor
- Ain Shams University
- Modality
- DNA Intercalators/Alkylators, Irreversible Covalent Inhibitors, RNA-Targeting Small Molecules
- Drugs
- capecitabine
- Conditions
- breast cancer
01
Overview
Phase 2, randomised, open-label trial of capecitabine in breast cancer (2 arms), sponsored by Ain Shams University. Primary endpoint: Progression-Free Survival at 24 months. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
A.I. + Capecitabine
Experimental arm receiving combination of oral chemotherapy and hormonal therapy.
A.I
Control arm receiving standard-of-care hormonal therapy.
03
Who it enrols
Adult women with hormone receptor-positive (ER+ and/or PR+) metastatic or recurrent breast cancer who have not received prior systemic therapy for advanced disease and have an ECOG status of 0-2.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Adverse events
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