Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Immune System Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Hypersensitivity

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Taxane

Patients will have the microdevice implanted prior to breast surgery, in the absence of neoadjuvant chemotherapy

Patients will have the device placed and retrieved on a core biopsy the following day, then receive neoadjuvant chemotherapy prior to definitive breast surgery.

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.

KIBUR MICRODEVICE

Conventional, standard of care neoadjuvant chemotherapy delivered irrespective of device readout

anthracycline and taxane based chemotherapy

Tiffany Traina, MD

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.

Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer

Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer

If we are able to collect data from at least 6 out of the 12 patients, we will deem this study feasible to conduct in a larger cohort of patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer	NCT02521363	Breast Cancer	KIBUR MICRODEVI... anthracycline a...	19 Years -	Memorial Sloan Kettering Cancer Center
Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer	NCT02521363	Breast Cancer	KIBUR MICRODEVI... anthracycline a...	19 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for in vivo drug sensitivity testing