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

The Washington University

Status: Enrolling

Conditions: Breast Neoplasms

Treatments: Procedure: Peripheral blood draw; Procedure: Bone marrow biopsy; Procedure: Breast tissue collection

Study type: Observational

Funder types: Other

Identifiers

NCT00353483

05-0648 / 201101961

Details and patient eligibility

About

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

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Recently diagnosed with clinical stage II, III, or IV breast cancer
• Planning to undergo neoadjuvant or adjuvant systemic therapy; patients who have already completed neoadjuvant systemic therapy are also eligible
• Must be >= 18 years of age
• If female, must not be pregnant
• Must not have Hepatitis B, C, or HIV
• Must be willing and able to sign informed consent document

Trial design

300 participants in 1 patient group

Tissue, blood, and bone marrow (optional) collection

Description:

* 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

Treatment:

Procedure: Breast tissue collection

Procedure: Bone marrow biopsy

Procedure: Peripheral blood draw