At a glance
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Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer
In Brief
A clinical study evaluating KIBUR MICRODEVICE and anthracycline and taxane based chemotherapy for Breast Cancer. Completed, enrolled 11 participants across 6 sites.
Detailed Summary
The purpose of this study is to test the safety and feasibility of placing and removing a small device that contains anti-cancer drugs in a breast tumor of patients who plan on having breast surgery without treatment prior or patients who plan on receiving standard preoperative chemotherapy prior to their breast surgery. This device may be able to predict what types of treatment work best against an individual's breast cancer. With this device, the investigators hope to be able to personalize treatment choices based on an individual's type of breast cancer.
Study Details
Timeline
Interventions
This device contains 16 reservoirs, each with a unique single agent or drug combination in microdose amounts of less than one millionth of a systemic patient dose. The device is implanted directly into the tumor during a biopsy procedure, and remains in situ for \~24 hours.
Conventional, standard of care neoadjuvant chemotherapy delivered irrespective of device readout