Full TitlePilot Trial of an Implantable Device for In Vivo Drug Sensitivity Testing in Patients with Early Stage, Triple Negative Breast Cancer
The purpose of this study is to evaluate the safety and feasibility of implanting a small investigational device inside a breast tumor before a patient receives standard presurgical chemotherapy for early-stage triple-negative breast cancer. The device is a small cylinder with pockets that contain low levels of various anticancer drugs that are released to treat nearby tumor tissue.
A day later, the device and a small amount of the surrounding breast tumor are removed and analyzed in a lab to look for signs of the tumor’s response. Doctors hope they can use this information to determine which drugs would be most active against a given tumor, which can help personalize treatment.
After the device is removed, patients in this study will receive standard chemotherapy given before surgery (“neoadjuvant treatment”), followed by surgery to remove the tumor. Researchers will evaluate the response of each patient’s tumor to the standard chemotherapy and compare this response to what the device predicted.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have early-stage triple-negative breast cancer that has not yet been treated.
- Patients’ tumors must be at least 2 cm in size.
- Patients must be candidates for neoadjuvant chemotherapy.
- Patients must be able to walk and do routine activities for more than half of their normal waking hours.
- This study is for patients age 18 and older