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

NCT06085742 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2023-0429
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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%

  Number of participants that have RDI of the CMC regimen is equal to or greater than 85%

  1 year

Secondary Outcomes (10)

• Safety of oral CMC regime per the number of participants experiencing adverse events

  1 year

• Invasive Disease Free Survival (iDFS)

  10 years

• Distant Disease Free Survival (DDFS)

  10 years

• Overall Survival (OS)

  10 years

• Participant outcomes using the Quality of Life (QOL) and EORTC QOL-C30 questionnaires

  10 years

Study Arms (1)

CMC orally

OTHER

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

Drug: Cyclophosphamide; Drug: Methotrexate; Drug: Capecitabine

Interventions

Cyclophosphamide DRUG

60mg/m2 PO once a day (21 continuous days)

CMC orally

Methotrexate DRUG

10mg/m2 PO BID on days 1, 8, and 15

CMC orally

Capecitabine DRUG

825mg/m2 PO BID on days 1-14

CMC orally

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 pre-operative endocrine therapy
• Treating Oncologist recommends adjuvant chemotherapy without concurrent biologic/targeted therapy. Patients may receive a CDK4/6 inhibitor after completion of all study treatment, concurrently with adjuvant endocrine therapy. Patients with a germline pathogenic/likely pathogenic variant in a DNA homologous repair gene (e.g. BRCA1, BRCA2, PALB2) may receive adjuvant PARP inhibitor therapy after completion of all study treatment.
• Tumor is estrogen receptor (ER)-positive (\> 10% by IHC) and/or progesterone receptor (PR)-positive (\> 10% by IHC), HER2-negative by IHC or FISH according to 2018 ASCO-CAP guidelines.
• AJCC pathologic stage:
• o pT1-3/pN0-2 based on sentinel lymph node biopsy or axillary dissection
• High risk gene expression profile (either luminal B on MammaPrint/BluePrint, or Recurrence Score \> 25 on Oncotype Dx). Study participants are not required to have a high-risk gene expression profile if they have a clinical high-risk tumor, defined as:
• Age \< 50 and any of the following:
• Involvement of 1-3 axillary lymph nodes with metastatic carcinoma (pN1mic/N1)
• grade 1 tumor \> 3 cm; or grade 2 tumor \> 2 cm; or grade 3 tumors \> 1 cm (size based on pathological assessment of the maximal dimension of the invasive component of the tumor)
• pT1c-T2 and Ki-67 \> 20%

You may not qualify if:

• Subjects meeting any of the criteria below are ineligible for this study:
• Prior cytotoxic chemotherapy for this breast cancer
• Any investigational agents administered during or within 2 weeks prior to start of CMC chemotherapy
• AJCC stage IIIB-IIIC or stage IV
• Active infection requiring systemic therapy
• Untreated HIV/AIDS
• Documented DYPD deficiency
• Pregnant or nursing
• Require anticoagulation with warfarin. Anticoagulation with low molecular weight heparins, heparin, or direct oral anticoagulants (DOACs) is permitted.
• Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.
• Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.
• Other major comorbidity (e.g. advanced cardiopulmonary disease, uncontrolled diabetes mellitus) that may affect the safety or efficacy assessment of this investigational regimen, as determined by study PI
• Inability to swallow pills
• Any medical condition interfering with absorption of oral medications
• Any contraindication for any chemotherapy drug used in the CMC regimen

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Methotrexate; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Abiola Ibreeheem, MD

CONTACT

312-413-1581; abiolai@uic.edu

Prathmika Jha, BS

CONTACT

312-413-2746; pjha7@uic.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 17, 2023
• Study Start: November 22, 2023
• Primary Completion (Estimated): September 1, 2034
• Study Completion (Estimated): September 1, 2034
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

US (1)