Canadian Cancer Trials Group Bulletins

Trial Management Group

Closed to accrual: IND.229

IND.229 A Phase 1b Pharmacodynamic Study of Durvalumab (MEDI4736) in Patients with HER-2 Positive Metastatic Breast Cancer (MBC) Receiving Trastuzumab was closed to further accrual on April 20, 2017.

Primary objective: To determine the recommended phase II dose of durvalumab given to patients with advanced/recurrent HER-2 positive metastatic breast cancer (MBC) who are receiving treatment with trastuzumab.

Secondary objectives:
  1. To describe the toxicities of durvalumab in patients receiving trastuzumab;
  2. To evaluate the response rate and clinical benefit rate of durvalumab (measured by RECIST 1.1/Immune Response Criteria) in patients receiving trastuzumab;
  3. To assess PD-L1 expression in paired biopsies pre and post treatment with durvalumab as a marker of response/benefit.
Please contact the study coordinator if you have questions: Heather Ritter,