NSABP B-50-I Katherine breast

NSABP B-50-I (Katherine): Trastuzumab Emtansine versus Trastuzumab as Adjuvant Therapy for Patients with HER2+ Primary Breast Cancer Who have Residual Tumor Present Pathologically in the Breast or Axillary lymph Nodes Following Preoperative Therapy

Type of Study
Cancer (Oncology) - Breast
Location
Swedish Cancer Institute
Short Description
Purpose: This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.
Status
Open to Enrollment
Principal Investigator
Tanya Wahl, M.D.
Eligibility Notes
  • HER2-positive breast cancer
  • Clinical stage T1-4/N0-3/M0 at presentation (patients with T1a/bN0 tumors will not be eligible)
  • Completion of preoperative systemic treatment consisting of at least 6 cycles with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab and at least 9 weeks of taxane-based therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • No stage IV (metastatic) breast cancer
  • No history of any prior (ipsi- or contralateral breast cancer except lobular carcinoma in situ
  • No evidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgery
  • No progressive disease during preoperative therapy
  • No patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons
  • No hstory of exposure to the following cumulative doses of anthracyclines:
    • Doxorubicin > 240 mg/m2 Epirubicin > 480 mg/m2 For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m2
  • No prior treatment with trastuzumab emtansine
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