NCT06085742

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	60mg/m2 PO once a day (21 continuous days)
DRUG	Methotrexate	10mg/m2 PO BID on days 1, 8, and 15
DRUG	Capecitabine	825mg/m2 PO BID on days 1-14

Timeline

• Start date: 2023-11-22
• Primary completion: 2034-09-01
• Completion: 2034-09-01
• First posted: 2023-10-17
• Last updated: 2025-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study