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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT06085742
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 22, 2023
Status verified
Dec 2025
Primary completion
Sep 30, 2034
Completion
Sep 30, 2034

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: CMC orally
    All agents in CMC are oral and conform to a 3-week = 1 cycle regimen. All subjects will receive Cyclophosphamide 60mg/m2 PO once a day (21 continuous days) Methotrexate 10mg/m2 PO BID on days 1, 8, and 15 Capecitabine 825mg/m2 PO BID on days 1-14

Primary Outcome Measure

Relative Dose Intensity (RDI) in patients treated with the CMC regimen. RDI is defined as the sum total of delivered drug in mg/m2/week for each drug in the CMC regimen per the number of participants that have equal to or greater than 85% [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of IllinoisChicagoIllinois60612
Abiola R Ibreeheem, MD
[email protected]
312-413-1581
Prathmika Jha, BS
[email protected]
312-413-2746

Find similar trials in Chicago, IL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Illinois· Chicago, IL

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