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

NCT02521363 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-08-22

Study results available
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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.

Conditions

Interventions

DEVICE

KIBUR MICRODEVICE

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.

DRUG

anthracycline and taxane based chemotherapy

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

Sponsors & Collaborators

Principal Investigators

  • Tiffany Traina, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-24
Primary Completion
2024-08-01
Completion
2024-08-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02521363 on ClinicalTrials.gov