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

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 Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: KIBUR MICRODEVICE; Drug: anthracycline and taxane based chemotherapy

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan-Kettering at Basking Ridge
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Monmouth
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan-Kettering Cancer Center at Commack
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • Rockville Centre, New York, United States, 11570
      • Memorial Sloan-Kettering Cancer Center at Mercy Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with histologically confirmed invasive breast cancer that is: Triple negative (ER<10%, PR<10%, and HER2 0/1+ or 2+/FISH not amplified)
• Tumor size 2cm or greater; N any; M0
• Tumor size 1cm or greater; N any; M0 (Cohort 1)
• Tumor size 2cm or greater; N any; M0 (Cohort 2)
• Candidate for curative breast cancer surgery (Cohort 1 or 2)
• Candidate for neoadjuvant chemotherapy with a standard of care, anthracycline-based regimen (Cohort 2 preferred over Cohort 1)
• Age >18 years of age
• ECOG performance status of ≤2
• Serum or urine pregnancy test negative within 2 weeks for women of childbearing potential.
• Willing and able to provide informed consent

Exclusion Criteria:

• Prior treatment including surgery, chemotherapy or radiation therapy for the current primary breast cancer.
• Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational device administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Upfront Breast Surgery; Patients will have the microdevice implanted prior to breast surgery, in the absence of neoadjuvant chemotherapy	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.
Experimental: Neoadjuvant Therapy; Patients will have the device placed and retrieved on a core biopsy the following day, then receive neoadjuvant chemotherapy prior to definitive breast surgery.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Implantable Devices	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.	Up to 1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Tiffany Traina, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2015
• Primary Completion (Actual): August 1, 2024
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: August 5, 2015
• First Submitted That Met QC Criteria: August 10, 2015
• First Posted (Estimated): August 13, 2015

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Triple Negative; Implantable Microdevice; In Vivo Drug Sensitivity Testing; HER2-Positive; 15-127
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Immune System Diseases; Skin Diseases; Breast Diseases; Hypersensitivity; Breast Neoplasms; Triple Negative Breast Neoplasms; Antineoplastic Agents; Taxane
• Other Study ID Numbers: 15-127