Clinical Trials Search
Clinical Trial 18079
Cancer Type: Breast
Interventions:E75; GM-CSF; Herceptin (Trastuzumab); Leukine (GM-CSF); Placebo; sargramostatin (GM-CSF)
Study Type: Treatment
Phase of Study: Phase II
- Hatem Soliman
Combination Immunotherapy with Herceptin and the HER2 Vaccine E75 in Low and Intermediate HER2-expressing Breast Cancer Patients to Prevent Recurrence
The purpose of this study is to (1) test the HER2/neu peptide (piece of the protein) E75 as a vaccine in combination with Herceptin (trastuzumab) to determine if it can prevent breast cancer recurrence; (2) to look at the immune system's response to the vaccine in combination with Herceptin; (3) to collect information on the vaccine in combination with Herceptin's safety and dosing.
In this study, we intend to assess the ability of the combination of Herceptin and the HER2 vaccine E75 (administered with the immunoadjuvant GM-CSF) given in the adjuvant setting to prevent recurrences in NP (or NN if negative for both estrogen (ER) and progesterone (PR) receptors) breast cancer patients with tumors that express low (1+) or intermediate (2+) levels of HER2. Enrolled patients will be randomized to receive Herceptin and E75 + GM-CSF or Herceptin with GM-CSF alone (no E75). The safety of the combination therapy will be documented, specifically to ensure that no additive cardiac toxicity results from combination HER2-directed therapy. Efficacy will be documented by comparing the DFS and immunological responses between treatment groups. Primary Objectives: The primary efficacy endpoint is to compare DFS at 24 months between treatment groups. The primary safety issue is to prove there is no additive cardiac toxicity with combination HER2-directed therapy. Secondary Objectives: A secondary endpoint of the trial is to compare DFS at 36 months. Immunologic responses to the vaccine will also be documented and correlated to clinical benefit.