BRE-08 Phase II Study of CMC Regimen for Early Stage Breast Cancer — BRE-08  

Breast Cancer Clinical Trial

Official title: BRE-08: A Phase II Study of an All-Oral Adjuvant Chemotherapy Regimen of Cyclophosphamide, Methotrexate, and Capecitabine (CMC) for Early-Stage Breast Cancer

Status Recruiting

Clinical Trial Summary

This is a non-randomized, single arm phase 2 trial of oral CMC based on conversion of doses that would be delivered with conventional metronomic CMF chemotherapy.

Clinical Trial Description

Participants who require adjuvant radiotherapy for locoregional management may opt to initiate radiotherapy following the fourth cycle of CMC with the final 4 cycles held during radiotherapy. Following completion of radiation therapy, participants may then resume with cycle 5 of CMC. The washout period before and after radiation therapy is a minimum of 2 weeks. Alternatively, patients may receive adjuvant radiotherapy after the completion of the final (8) cycle of CMC. The study team will collect data on cyclophosphamide, methotrexate, and capecitabine compliance at routine clinical visits every 3 weeks. In addition, standard electrolyte, chemistry and liver function laboratory monitoring will be conducted at each clinic visit ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT06085742
• Study type: Interventional
• Source: University of Illinois at Chicago
• Contact: Abiola Ibreeheem, MD
• Phone: 312-413-1581
• Email: abiolai@uic.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: November 22, 2023
• Completion date: September 2034