Providence studies new therapy for patients with curable breast cancer
October 22, 2013
A new phase III breast cancer trial for women with HER2 overexpressed residual tumor in the breast or axilliary lymph nodes after preoperative treatment
Providence Cancer Center is the only site in Oregon to open the KATHERINE study (NSABP B-50-I), evaluating the efficacy and safety of trastuzumab emtansine (Kadcyla) versus trastuzumab (Herceptin) as adjuvant (postoperative) therapy for breast cancer.
Breast cancer patients who do not achieve a pathologic complete response after preoperative treatment are at an increased risk for recurrence. Trastuzumab emtansine is a novel antibody-drug conjugate, designed specifically for the treatment of HER2-positive breast cancer. It was approved in February 2013 for women with advanced, incurable disease. The trials extends the therapy to patients with early-stage, curable breast cancer.
The trial began enrolling patients in May 2013. Patients must have HER2-positive invasive breast cancer with negative or positive nodes at initial diagnosis. Bilateral disease is allowed if cancers in each breast test as HER2-positive. Surgical margins after mastectomy or breast-conserving surgery must have no residual disease. Surgical removal of all clinically evident disease in lymph nodes is required. Patients with stage IV metastatic disease are not eligible. Patients will be randomized to receive either trastuzumab or trastuzumab emtansine for 14 cycles or 42 weeks.
Official title: A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients with HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy
View NCI full trial information
Principal investigator: Alison Conlin, M.D., medical oncologist, Providence Cancer Center
Sponsor: Hoffmann-La Roche
Contact at Providence Cancer Center:
Nikki Moxon, RN, BSN, OCN, clinical research nurse for breast trials
Providence Cancer Center
4805 NE Glisan St., Suite 2N35
Portland, OR 97213