5303S-12: B-43 breast

CTSU B-43: A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy

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

Purpose: This randomized phase III trial is studying radiation therapy to see how well it works compared with or without trastuzumab in treating women with ductal carcinoma in situ who have undergone lumpectomy.


Open to Enrollment
Principal Investigator
Gary Goodman, M.D.
Eligibility Notes
  • Histologically confirmed ductal carcinoma in situ (DCIS)


    • Mixed DCIS and lobular carcinoma in situ (LCIS) allowed



  • HER2 receptor-positive



  • Must have undergone resection by lumpectomy



  • None of the following allowed:



    • Patients who require mastectomy



    • Invasive (including microinvasion staged as T1mic) breast cancer (DCIS "suspicious" for microinvasion, but not confirmed, allowed)



    • Nodal staging of pN1 (including pN1mi) (axillary staging not required)



    • DCIS present in more than one quadrant (multicentric)



    • Masses or clusters of calcification that are clinically or mammographically suspicious unless biopsied and proven to be benign



    • Contralateral breast cancer (including DCIS)



    • History of breast cancer, including DCIS (history of LCIS allowed)



  • Estrogen receptor and/or progesterone receptor-positive or -negative



  • No prior whole or partial breast irradiation

  • No prior anthracycline chemotherapy for any malignancy

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