Comparison of the Breast Tumor Microenvironment

NCT03165487 | Active Not Recruiting DMC

• 1 other identifier: AAAO7708
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Triple Negative Breast Cancer; Hormone Receptor Positive Malignant Neoplasm of Breast

Keywords

Triple Negative Breast Cancer; microenvironment; IORT; Hormone Receptor Positive, HER 2 negative

Outcome Measures

Primary Outcomes (1)

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

  This outcome measure is designed to measure the amount of TILs in newly diagnosed luminal A and Triple Negative Breast Cancer (TNBC) tumors. The mean percent change in TILS in tumor tissue from initial core biopsy samples will be compared with pathology samples from definitive surgery after IORT between the two different breast cancer sub-types.

  Two weeks

Study Arms (2)

Luminal A Breast Cancer

Luminal A Breast cancer subjects will have tissue specimens and blood collected before and after IORT during the Breast conserving surgery.

Other: Breast tissue collection; Other: Blood sample collection

Triple Negative Breast Cancer

Triple Negative breast cancer subjects will have tissue specimens and blood collected before and after IORT during the Breast conserving surgery.

Other: Breast tissue collection; Other: Blood sample collection

Interventions

Breast tissue collection OTHER

During Breast Conservation Surgery, one sample will be collected before and after IORT.

Luminal A Breast Cancer; Triple Negative Breast Cancer

Blood sample collection OTHER

Blood will be collected before and after IORT, and at the two week follow-up.

Luminal A Breast Cancer; Triple Negative Breast Cancer

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects will be recruited from the outpatient Breast Surgery and Radiation Oncology Clinics of Columbia University

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Two specimens will be collected. A shaved margin of the area surrounding the tumor, considered as "normal" tissue, will be collected at two time points. The tissue will be collected prior to intraoperative radiation therapy, and immediately after. Blood will also be collected.

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Eileen Connolly, MD

  Assistant Professor of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 24, 2017
• Study Start: September 28, 2017
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)