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Oral Chemotherapy for Early Stage Breast Cancer (BRE-08 Trial)

Phase 2

Recruiting

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years of age at time of consent

ECOG performance status 0, 1, or 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

BRE-08 Trial Summary

This trial tests if a new type of oral chemotherapy can help treat cancer.

Who is the study for?

This trial is for adults with invasive breast cancer that's been surgically removed, without signs of distant spread. It's specifically for those with high-risk gene profiles or clinical features, and normal organ function. Participants must not be pregnant, able to take oral medication, and willing to use two forms of birth control if applicable.Check my eligibility

What is being tested?

The BRE-08 Phase II study tests a chemotherapy combination called CMC (Capecitabine, Cyclophosphamide, Methotrexate) given orally in a non-randomized setting to see its effectiveness in early-stage breast cancer patients who have undergone surgery.See study design

What are the potential side effects?

Potential side effects from the CMC regimen may include nausea, vomiting, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems, fatigue and mouth sores. Each patient may experience side effects differently.

BRE-08 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself and perform daily activities.

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My breast cancer was confirmed by a biopsy or surgery.

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My cancer has not spread to distant parts of my body.

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My tumor is positive for estrogen or progesterone receptors and negative for HER2.

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My kidney function, measured by creatinine levels, is within the normal range.

BRE-08 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome 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%

Secondary outcome measures

Discontinuation of protocol therapy

Distant Disease Free Survival (DDFS)

Invasive Disease Free Survival (iDFS)

+7 more

BRE-08 Trial Design

1Treatment groups

Experimental Treatment

Group I: CMC orallyExperimental Treatment3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Methotrexate

2013

Completed Phase 4

~3800

Capecitabine

2013

Completed Phase 3

~3420

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor

609 Previous Clinical Trials

1,559,284 Total Patients Enrolled

10 Trials studying Breast Cancer

1,342,331 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies in this clinical trial?

"Confirmed. The trial, which opened its recruitment on October 1st 2023 is currently still recruiting patients according to clinicaltrials.gov's latest update from October 9th of this year."

Answered by AI

Is the Single Arm protocol recognized by the FDA?

"There is some evidence that Single Arm is safe, leading to it receiving a score of 2 on our scale from 1-3. This drug has only undergone Phase 2 trials so far and no data yet exists supporting its efficacy in humans."

Answered by AI

How many participants are being accepted to take part in this research?

"Affirmative. According to clinicaltrials.gov , this research project is still actively recruiting participants, with the initial posting dating back to October 1st 2023 and a recent update on October 9th of that same year. 25 people are needed from one medical centre for the study's completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Abiola Ibraheem 2023. "BRE-08 Phase II Study of CMC Regimen for Early Stage Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06085742.