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Breast CancerPhase 2BRE-08NCT06085742

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

A Phase 2 study testing Cyclophosphamide, Methotrexate and Capecitabine in people with Breast Cancer, run by University of Illinois Chicago at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Cyclophosphamide, Methotrexate and Capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
22 Nov 2023to Sep 2034
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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%
  • Presence of lymphovascular invasion stage IIIA (pT3/pN1 or pT1-3/pN2)
  • Age > 50 and any of the following:
  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Abiola Ibreeheem, MD contact

312-413-1581

abiolai@uic.edu

Prathmika Jha, BS contact

312-413-2746

pjha7@uic.edu

United States1 site, 1 recruiting

  • University of Illinois

    Chicago, Illinois, 60612

    Abiola R Ibreeheem, MD, 312-413-1581, abiolai@uic.edu

    Prathmika Jha, BS, 312-413-2746, pjha7@uic.edu

    Recruiting

Other trials in United States

About this study

Official title: BRE-08: A Phase II Study of an All-Oral Adjuvant Chemotherapy Regimen of Cyclophosphamide, Methotrexate, and Capecitabine (CMC) for Early-Stage Breast Cancer

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.

Read the detailed description

Participants who require adjuvant radiotherapy for locoregional management may opt to initiate radiotherapy following the fourth cycle of CMC with the final 4 cycles held during radiotherapy. Following completion of radiation therapy, participants may then resume with cycle 5 of CMC. The washout period before and after radiation therapy is a minimum of 2 weeks. Alternatively, patients may receive adjuvant radiotherapy after the completion of the final (8) cycle of CMC.

The study team will collect data on cyclophosphamide, methotrexate, and capecitabine compliance at routine clinical visits every 3 weeks. In addition, standard electrolyte, chemistry and liver function laboratory monitoring will be conducted at each clinic visit

Conditions
Breast Cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06085742
Study groupRoleWhat they receive
CMC orallyOtherAll 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
Receives: Drug: Cyclophosphamide; Drug: Methotrexate; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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%

    Measured: 1 year

Secondary outcomes (10)

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

    Number of participants having adverse event using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5

    Measured: 1 year

  2. Invasive Disease Free Survival (iDFS)

    Number of participants that have iDFS, defined as the time from enrollment to

    documentation of the first of the following: invasive cancer in the ipsilateral breast/chest wall or regional nodes, contralateral invasive breast or regional nodes, distant metastases, or death from any cause

    Measured: 10 years

  3. Distant Disease Free Survival (DDFS)

    Number of participants that have DDFS defined as the time from enrollment to documentation of distant metastases or death from any cause.

    Measured: 10 years

  4. Overall Survival (OS)

    Number of participants that have OS defined as the time from study enrollment to the date of the subject's death

    Measured: 10 years

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

    Number of participants having good outcome versus low outcomes. High score means worse health outcomes and low score means better health outcomes

    Measured: 10 years

  6. Protocol therapy interruption

    Number of participants that have protocol therapy interruption

    Measured: 10 years

  7. Discontinuation of protocol therapy

    Number of participants that have discontinuation of protocol therapy

    Measured: 10 years

  8. Rates of dose reduction of cyclophosphamide

    Number of participants that have dose reduction of cyclophosphamide

    Measured: 10 years

  9. Rates of dose reduction of methotrexate

    Number of participants that have dose reduction of methotrexate

    Measured: 10 years

  10. Rates of dose reduction of capecitabine

    Number of participants that have dose reduction of capecitabine

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2023
  2. Study start22 Nov 2023
  3. Primary completionSep 2034 (estimated)
  4. Study completionSep 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06085742
Sponsor's protocol ID
2023-0429
Acronym
BRE-08
Status last verified
Dec 2025
First submitted
9 Oct 2023
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cyclophosphamide, Methotrexate and Capecitabine in people with Breast Cancer, run by University of Illinois Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Abiola Ibreeheem, MD (312-413-1581, abiolai@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06085742.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.

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