RecruitingPhase 2NCT06085742

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


Sponsor

University of Illinois at Chicago

Enrollment

25 participants

Start Date

Nov 22, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a chemotherapy combination called CMC (cyclophosphamide, methotrexate, and capecitabine) as a treatment after surgery for early-stage breast cancer. Researchers want to find out if this regimen is effective for people who need additional treatment after their tumor has been removed. **You may be eligible if...** - You are 18 or older - You have been diagnosed with invasive breast cancer confirmed by biopsy - You had surgery to remove your breast tumor within the last 90 days - Your cancer has not spread to distant organs - Your doctor recommends chemotherapy after surgery (without concurrent targeted therapy) - You have not had prior chemotherapy or targeted therapy for this cancer **You may NOT be eligible if...** - Your cancer has spread to other parts of the body - You had prior systemic treatment other than endocrine (hormone) therapy before surgery - You are pregnant or breastfeeding - You have significant heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

University of Illinois

Chicago, Illinois, United States

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NCT06085742


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