Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Hormones

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

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

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

Breast tissue collection

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

Blood sample collection

Eileen Connolly, MD

Mariamne Reyna

Eileen Conolly, MD

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.

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.

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.

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

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.

Columbia University

Assistant Professor

Blood and Lymph Conditions

Bone Marrow Neoplasms

Hematologic Neoplasms

Bone Marrow Diseases

Hematologic Diseases

* Undergo neoadjuvant systemic therapy

  * initial surgery for sentinel lymph node biopsy/portacath placement
  * definitive cancer surgery (if applicable)
  * when portacath is removed (1 year, if available)
  * if metastatic disease develops or is present in accessible sites, a sample may be collected at the time of specimen collection for diagnosis
* Undergo Adjuvant Systemic Therapy

  * initial surgery for a sentinel lymph node biopsy/portacath placement
  * when portacath is removed (1 year, if available)
  * If metastatic disease develops or is present in accessible sites, a sample may be collected at the time of specimen collection for diagnosis.
* Undergone neoadjuvant systemic therapy

  * during definitive cancer surgery/portacath removal (if available)
  * if metastatic disease develops or is present in accessible sites, a sample may be collected at the time of specimen collection for diagnosis

Peripheral blood draw

Bone marrow biopsy

Rebecca Aft, MD, PhD

Tracey Guthrie

Mark Watson, MD, PhD

William Gillanders, MD

Timothy Eberlein, MD

Katherine Weilbaecher, MD

Michael Naughton, MD

Shunqiang Li, MD

Julie Margenthaler, MD

Cynthia Ma, MD

Katherine Glover-Collins, MD, PhD

Caron Rigden, MD

Rama Suresh, MD

Gregory Longmore, MD

Ashley Frith, MD

Foluso Ademuyiwa, MD

Peter Oppelt, MD

Haeseong Park, MD

Ron Bose, MD, PhD

Leonel Hernandez Aya, MD

Mathew Cherian, MD

Lindsay Peterson, MD

Cara Cipriano, MD

Rebecca Aft, M.D., Ph.D.

The main purpose of this study is to compare genetic markers present on tumor cells before and after chemotherapy.

In this study, the investigators propose that persistent disseminated tumor cells (DTC) present after systemic therapy represent a unique subpopulation of all DTC, are predictors of a poor response to systemic therapy and correlate with poor clinical outcome. The investigators hypothesize that systemic therapy-resistant DTC can be identified by their expression of a unique constellation of tumor marker proteins which may be similar to those expressed by breast cancer stem cells. In this research, the investigators' specific aims are : 1) to characterize tumor markers expressed by DTC which are present after systemic therapy, 2) to compare the expression of these markers to that on DTC detected prior to systemic therapy, 3) to correlate expression of the defined tumor markers on DTC with clinical outcome of breast cancer patients to identify those markers that are predictive of disease recurrence, 4) to utilize biomarkers identified in Specific Aims 1 and 2 to isolate purified DTC for further molecular analysis.

Breast cancer tissue, peripheral blood, and bone marrow

Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells

Washington University School of Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Comparison of the Breast Tumor Microenvironment	NCT03165487	Triple Negative... Hormone Recepto...	Breast tissue c... Blood sample co...	50 Years -	Columbia University
Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells	NCT00353483	Breast Neoplasm...	Peripheral bloo... Breast tissue c... Bone marrow bio...	18 Years -	Washington University School of Medicine

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