5278S-12: B-49 breast

CTSU B-49: 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

Type of Study
Cancer (Oncology) - Breast
Swedish Cancer Institute
Short Description

Purpose: This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating women with non-metastatic breast cancer.

Open to Enrollment
Principal Investigator
Gary Goodman, M.D.
Eligibility Notes
  • Tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
  • Breast cancer must be HER2-negative
  • All of the following staging criteria must be met according to AJCC criteria:
    • By pathologic evaluation, primary tumor must be pT1-3
    • By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b
    • If pN0, at least one of the following criteria must be met:
      • Estrogen receptor (ER) negative AND progesterone receptor (PgR) negative
      • Pathologic tumor size > 2.0 cm
      • T1c (pathologic tumor size > 1.0 cm but ≤ 2.0 cm) and ER positive (PgR status may be positive or negative) and either grade 3 histology or Oncotype DX® Recurrence Score of ≥ 25
    • No T4 tumors, including inflammatory breast cancer
  • No synchronous or previous contralateral invasive breast cancer (patients with synchronous and/or previous contralateral ductal carcinoma in situ [DCIS] are eligible)
  • No history of ipsilateral invasive breast cancer or ipsilateral DCIS
  • Patients must have undergone either a total mastectomy or breast-conserving surgery (lumpectomy)
  • No previous therapy with anthracyclines or taxanes for any malignancy
  • No chemotherapy administered for the currently diagnosed breast cancer prior to randomization
  • No continued endocrine therapy such as raloxifene or tamoxifen (or other selective estrogen receptor modulator [SERM]) or an aromatase inhibitor
  • No whole breast radiotherapy (RT) prior to randomization or partial breast RT that cannot be completed on or before the date of randomization
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
(206) 215-3086