Phase 2 Study of CMC Regimen for Early Stage Breast Cancer
This study is testing a combination of three oral medications – Cyclophosphamide, Methotrexate, and Capecitabine (CMC regimen) – for people with early-stage breast cancer. The goal is to see how well patients can stick to the treatment plan over time. You may be able to join if you are 18 or older, have been diagnosed with invasive breast cancer, and have had surgery to remove the tumor. The study will measure the "Relative Dose Intensity" (RDI), which means how much of the medication you actually receive compared to the planned amount, specifically looking for at least 85% of the planned dose at one year. The current status of this study is unclear, and it plans to enroll 25 participants.
- Study design
- This is a Phase 2 study, meaning it's an early-stage trial looking at safety and effectiveness. It's a single-arm study, so all 25 participants will receive the same CMC regimen.
- What's involved
- You will take oral medications daily or on specific days, and have routine clinic visits every 3 weeks for blood tests and to check medication compliance.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goal is measured at 1 year, indicating follow-up for at least that duration.
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NCT06085742
BRE-08 Phase II Study of CMC Regimen for Early Stage Breast Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of Illinois at ChicagoInvestigator-initiated
~25 participants
Updated 2025-12-19 on ClinicalTrials.gov
What's tested:CyclophosphamideMethotrexateCapecitabine
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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%
Measured over 1 year
Conditions
Where it's being run
1 sites across 1 statesIllinois1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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:
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:
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%
Presence of lymphovascular invasion stage IIIA (pT3/pN1 or pT1-3/pN2)
Primary tumor \> 5 cm (pT3)
stage IIIA (pT3/pN1 or pT1-3/pN2)
Adequate organ function as defined in Table 1. All screening labs to be obtained within 30 days prior to registration.
Patients with synchronous bilateral primary breast tumors or multiple ipsilateral primary breast tumors are eligible if the treating Oncologist determines that the CMC regimen is appropriate therapy for all primary tumors requiring chemotherapy.
Able to provide written informed consent and HIPAA authorization for release of personal health information.
Women of childbearing potential must agree to use 2 methods of birth control, at least one being a barrier form of contraception if they are sexually active with a male partner unless they are considered highly unlikely to conceive as defined in section 8.6, and cannot be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.
As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
Patients with history of HIV/AIDS (acquired immunodeficiency syndrome) are eligible for this study if they are receiving anti-retroviral therapy and it does not include any medications known to alter metabolism or tolerability of component drugs in the CMC regimen (see Appendix), and either of the following criteria are met:
Patients without a history of AIDS-defining opportunistic infections.
Patients with a history of AIDS-defining opportunistic infections, but they have not had an opportunistic infection within the past 12 months.
Patients with Hepatitis B (HBV): chronic carriers of HBV infection (HBsAg-positive) or individuals who have serologic evidence of a resolved prior HBV infection (i.e., HBsAg-negative and anti-HBc-positive) are eligible if they are receiving appropriate suppressive antiviral therapy that does not include medications known to alter metabolism or tolerability of component drugs in CMC (see Appendix) prior to initiation of cancer therapy, and liver function tests meet study eligibility criteria.
Patients with Hepatitis C (HCV): patients with a history of HCV infection who have completed curative antiviral treatment are eligible if the HCV RNA viral load is below the limit of quantification within 90 days of study enrollment. Patients on concurrent HCV treatment must have HCV RNA viral load below the limit of quantification within 30 days of study enrollment. Patients must also meet liver function test eligibility requirements and antiviral therapy does not include medications known to alter metabolism or tolerability of component drugs in CMC.
Exclusion
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
Active and ongoing use of medicines known to alter metabolism or tolerability of component drugs in CMC.
Prisoners
Unable or unwilling to take a large number of oral pills
What this trial measures
- 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%1 year
Number of participants that have RDI of the CMC regimen is equal to or greater than 85%