NSABP-B49

Trial

Clinical Trial Title

NSABP-B49

Trial Status

Open to Enrollment

Start Date

July 10, 2012

Location

Trial Type

Cancer (Oncology)

Specific Condition

Breast Cancer

Description

A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

Eligibility Criteria

  • Patients must have unilateral invasive adenocarcinoma of the breast on histologic exam.
  • Tumor sample must be available for submission.
  • Tumor must be HER2-negative; if equivocal, patients are eligible if there is no plan to administer HER2-directed therapy.
  • Patients must have either a total mastectomy or a lumpectomy; both with margins clear of invasive tumor and DCIS.
  • ER analysis must be performed on the primary tumor prior to randomization. If ER-, PgR status must be assessed.
  • No clinical or radiologic evidence of metastatic disease.
  • No history of ipsilateral invasive cancer or DCIS.
  • No previous therapy with anthracyclines or taxanes for any malignancy.
  • No chemotherapy administered for the currently diagnosed breast cancer prior to randomization.
  • No current endocrine or sex hormonal therapy.

IRB Number

Legacy IRB

Notes

Sponsored by: NSABP

Principal Investigator Name

Jay Andersen, MD

Contact Name

Legacy Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Last Updated: Wednesday, September 18, 2013 01:35:02 PM

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