BRE-08 Phase II Study of CMC Regimen for Early Stage Breast Cancer
NCT06085742 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2025-12-19
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.
Conditions
Interventions
- DRUG
-
825mg/m2 PO BID on days 1-14
- DRUG
-
60mg/m2 PO once a day (21 continuous days)
- DRUG
-
Methotrexate
10mg/m2 PO BID on days 1, 8, and 15
Sponsors & Collaborators
-
University of Illinois at Chicago
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-22
- Primary Completion
- 2034-09-30
- Completion
- 2034-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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