BRE-08: A Phase II Study of an All-Oral Adjuvant Chemotherapy Regimen of Cyclophosphamide, Methotrexate, and Capecitabine (CMC) for Early-Stage Breast Cancer
University of Illinois at Chicago
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.
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 ev…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: I• Age ≥ 18 years of age at time of consent * ECOG performance status 0, 1, or 2 * Histologically confirmed invasive breast cancer documented by biopsy or surgical excision. * Underwent potentially curative resection of primary breast tumor(s) with no gross residual local-regional disease (patients with microscopically positive margins are eligible if adjuvant radiotherapy is planned), with most recent breast or axillary surgery \< 90 days prior to date of signed consent. * No evidence of distant metastatic disease * No prior systemic therapy for this cancer other than pr…
Interventions
- DrugCyclophosphamide
60mg/m2 PO once a day (21 continuous days)
- DrugMethotrexate
10mg/m2 PO BID on days 1, 8, and 15
- DrugCapecitabine
825mg/m2 PO BID on days 1-14
Location
- University of IllinoisChicago, Illinois