Protocol
12-115
Full Title
A Randomized Multicenter, Double-blind, Placebo-controlled Comparison of Chemotherapy plus Trastuzumab plus Placebo versus Chemotherapy plus Trastuzumab plus Pertuzumab as Adjuvant Therapy in Patients with Operable HER2-positive Primary Breast Cancer
Purpose
Trastuzumab (Herceptin) is a drug widely used to treat women with breast cancers that produce high levels of the HER2 protein. It is very effective, but in some women the cancer returns. In this study, researchers are evaluating the addition of pertuzumab (Perjeta), another drug that targets HER2, to treatment with chemotherapy and trastuzumab in women with HER2-positive breast cancer when given after surgery, to see if this combination is more effective than chemotherapy and trastuzumab alone for slowing cancer growth and improving survival.
Patients in this study will be randomly assigned to receive chemotherapy, trastuzumab, and pertuzumab or chemotherapy, trastuzumab, and a placebo. The treatment is given intravenously (by vein).
Investigator
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patient must have stage I-III breast cancer (has not metastasized) which is positive for the HER2 protein.
- Patients must have surgery to remove the breast cancer within 3 to 7 weeks of enrollment in the study.
- Patients may not have had prior chemotherapy or radiation therapy.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- Patients must be age 18 or older.
For more information about this study and to inquire about eligibility, please contact Dr. Chau Dang at 646-888-5426.
Disease(s)
Breast Cancer
Locations
Related Diseases
