Breast Cancer Clinical Trial

Comparison of the Breast Tumor Microenvironment

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.

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Full 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.

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Eligibility Criteria

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 is for people with:

Breast Cancer

Estimated Enrollment:

30

Study ID:

NCT03165487

Recruitment Status:

Recruiting

Sponsor:

Columbia University

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There is 1 Location for this study

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Columbia University Irving Medical Center
New York New York, 10032, United States More Info
Eileen Conolly, MD
Contact
212-305-5050
[email protected]
Mariamne Reyna
Contact
646-317-4244
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

30

Study ID:

NCT03165487

Recruitment Status:

Recruiting

Sponsor:


Columbia University

How clear is this clinincal trial information?

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