5128S-11: B-47 breast

CTSU B-47: A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of TC or Four Cycles of AC Followed by Four Cycles of Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-N

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

Purpose: This randomized phase III clinical trial is studying chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer.

Status
Open to Enrollment
Principal Investigator
Gary Goodman, M.D.
Eligibility Notes
  • Unilateral invasive adenocarcinoma of the breast on histologic examination
  • Primary tumor must be pT1-3
  • Ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN2b, pN3a, or pN3b
    • If pN0, one of the following criteria must be met:
      • pT2 and estrogen receptor (ER) negative and progesterone receptor (PgR) negative
      • pT2 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 definitive clinical or radiologic evidence of metastatic disease
  • No synchronous or previous contralateral invasive breast cancer (patients with synchronous and/or previous contralateral DCIS or LCIS are eligible)
  • No previous ipsilateral invasive breast cancer or ipsilateral DCIS (patients with synchronous or previous ipsilateral LCIS are eligible)
  • No previous therapy with anthracyclines, taxanes, or trastuzumab for any malignancy
  • No chemotherapy or HER2-targeted therapy administered for the currently diagnosed breast cancer prior to randomization
  • No whole-breast RT prior to randomization or partial-breast RT that cannot be completed on or before the date of randomization
  • No continued endocrine therapy such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor (patients are eligible if these medications are discontinued prior to randomization)
  • No continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy (patients are eligible if these medications are discontinued prior to 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.
Phone
(206) 215-3086
Email
CancerResearch@swedish.org