A Phase 2 Clinical Trial Assessing the Correlation of Early Changes in Standardized Uptake Value (SUV) on Positron Emission Tomography (PET) with Pathological Complete Response (pCR) to Pertuzumab and Trastuzumab in Patients with Primary Operable HER2-Positive Breast Cancer
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
This research is being done to determine if changes seen on a PET (Positron Emission Tomography) scan can predict which patients are most likely to respond to the combination treatment of trastuzumab and pertuzumab when given before surgery (preoperatively). PET scans are a non-experimental imaging procedure used frequently in the clinic.Pertuzumab (PerjetaÂ®) and trastuzumab (HerceptinÂ®) are both approved by the Food and Drug Administration (FDA) for the treatment of breast cancer. Pertuzumab is approved for the treatment of metastatic breast cancer, so its use in this study (as a preoperative treatment) is investigational. Trastuzumab is approved for newly diagnosed and metastatic breast cancer. The FDA is allowing the use of pertuzumab in this study.
Patients with newly diagnosed breast cancer that is HER2 positive and estrogen or progesterone receptor (ER/PR) negative (or very low) who are planning preoperative treatment may be eligible for this trial. Participants must be willing to have a biopsy of their tumor prior to and about two weeks after starting treatment.
Before starting treatment in this study, you will need to sign a consent form. You will have a doctor's visit, routine and research blood tests, a baseline PET scan, an EKG and echocardiogram (or MUGA), and a breast biopsy prior to starting. You will receive both pertuzumab and trastuzumab. These drugs are given intravenously in the clinic every 3 weeks for a total of 12 weeks. About 2 weeks after your first treatment, you will have a repeat PET scan, research blood samples, and biopsy of your breast tumor. You will have standard lab work done and see your provider prior to each study treatment.After you complete the study treatment, you will have your breast cancer surgery and receive any additional treatment at the direction of your doctors.
07/01/2016 05:03 AM