Comparison of the Breast Tumor Microenvironment

Differential Comparison of the Breast Tumor Microenvironment Between Luminal A and Triple Negative Breast Cancer With and Without Radiation Treatment

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.

Study Overview

• Status: Recruiting
• Conditions: Triple Negative Breast Cancer; Hormone Receptor Positive Malignant Neoplasm of Breast
• Intervention / Treatment: Other: Breast tissue collection; Other: Blood sample collection

Detailed Description

There is evidence that the normal tissue around a tumor plays a role in determining how the tumor behaves, including how it will respond to treatments and how likely it is to recur. In breast cancer, radiation is used to decrease the chance of recurrence in the area where the tumor is removed. This risk of recurrence varies between different types of breast cancer. The investigators seek to study the proteins produced in normal tissue surrounding breast tumors. The tissue will be taken from women who are receiving radiation to the breast at the time of their surgery (known as intraoperative radiation), one specimen taken before radiation and one after. A new process will be used to stabilize the tissue rapidly and allow the proteins to be identified before they break down. This will allow us to identify differences in the proteins produced by cells before and after radiation and between two types of breast cancers, luminal A (less likely to recur) and triple negative (more likely to recur). Identifying these differences in proteins may allow them to be used in the future as markers to predict the likelihood of tumors recurring.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; During Breast Conservation Surgery, one sample will be collected before and after IORT.; Other: Blood sample collection; Blood will be collected before and after IORT, and at the two week follow-up.
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; During Breast Conservation Surgery, one sample will be collected before and after IORT.; Other: Blood sample collection; Blood will be collected before and after IORT, and at the two week follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2017
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: May 22, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Triple Negative Breast Cancer; IORT; microenvironment; Hormone Receptor Positive, HER 2 negative
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Site; Breast Diseases; Neoplasms; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: AAAO7708

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No