Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06085742

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

Led by University of Illinois at Chicago · Updated on 2025-12-19

25

Participants Needed

1

Research Sites

562 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at time of consent
  • ECOG performance status of 0, 1, or 2
  • Histologically confirmed invasive breast cancer
  • Underwent potentially curative surgery for primary breast tumor with no gross residual local-regional disease
  • No evidence of distant metastatic disease
  • No prior systemic therapy for this cancer except pre-operative endocrine therapy
  • Treating oncologist recommends adjuvant chemotherapy without concurrent biologic/targeted therapy
  • Tumor is estrogen receptor-positive (>10%) and/or progesterone receptor-positive (>10%), HER2-negative
  • AJCC pathologic stage pT1-3/pN0-2
  • High risk gene expression profile or clinical high-risk tumor based on age and tumor characteristics
  • Adequate organ function per study requirements
  • Able to provide written informed consent and HIPAA authorization
  • Women of childbearing potential agree to use two forms of contraception and are not pregnant or breastfeeding
  • Ability to understand and comply with study procedures
  • Patients with HIV/AIDS on stable anti-retroviral therapy meeting specific criteria
  • Patients with Hepatitis B or C meeting specific treatment and liver function criteria
  • Patients with synchronous bilateral or multiple ipsilateral primary tumors eligible if CMC is appropriate for all tumors
Not Eligible

You will not qualify if you...

  • Prior cytotoxic chemotherapy for this breast cancer
  • Use of investigational agents during or within 2 weeks prior to start of CMC chemotherapy
  • AJCC stage IIIB-IIIC or stage IV breast cancer
  • Active infection requiring systemic therapy
  • Untreated HIV/AIDS
  • Documented DYPD deficiency
  • Pregnant or nursing
  • Require warfarin anticoagulation (other anticoagulants allowed)
  • Prior or concurrent malignancy interfering with study assessment
  • Mental or medical condition preventing informed consent or participation
  • Major comorbidities affecting safety or efficacy assessment
  • Inability to swallow pills
  • Medical conditions interfering with oral medication absorption
  • Contraindications to any chemotherapy drug in CMC regimen
  • Use of medications altering metabolism or tolerability of CMC drugs
  • Prisoners
  • Unable or unwilling to take large number of oral pills

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Illinois

Chicago, Illinois, United States, 60612

Actively Recruiting

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Research Team

A

Abiola Ibreeheem, MD

CONTACT

P

Prathmika Jha, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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