Active — Not RecruitingNot Applicable

Comparison of the Breast Tumor Microenvironment

United States14 participantsStarted 2017-09-28

Plain-language summary

The goal of the project is to identify a molecular signature of tumor stroma from "normal" adjacent breast tissue obtained prospectively at the time of breast conserving surgery before and after receiving intraoperative radiation therapy (IORT) in subjects that have luminal A and triple negative breast cancer. IORT is considered as being standard of care.

Who can participate

Age range50 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female, age greater than or equal to 40 * Core biopsy proven invasive breast carcinoma or ductal carcinoma in situ (DCIS), all subtypes excluding invasive lobular carcinoma due to increased risk for multifocal disease * Human epidermal growth factor receptor 2 (HER2) negative regardless of hormone receptor status * Clinically less than or equal to 3cm unifocal lesion * Clinically node negative * Must have diagnostic mammogram performed within last 6 months * Eastern Cooperative Oncology Group Performance Status (ECOG PS) less than or equal to 1 * Appropriate renal, liver, and hematologic lab values * Ability to give informed consent Exclusion Criteria: * Multifocal disease * Clinically N1 disease at diagnosis * Invasive lobular carcinoma * Metastatic disease * Patients for whom RT would be contraindicated (e.g., connective tissue disorder or prior ipsilateral breast radiation) * Patients with known BRCA1/2 mutations * Pregnant or nursing

What they're measuring

Number of subjects with significant mean percent change in Tumor Infiltrating Lymphocytes (TILs)

Timeframe: Two weeks

Trial details

NCT IDNCT03165487

SponsorColumbia University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-01