search
Back to results

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

Primary Purpose

Breast Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
KIBUR MICRODEVICE
anthracycline and taxane based chemotherapy
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Implantable Microdevice, In Vivo Drug Sensitivity Testing, HER2-Positive, Triple Negative, 15-127

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering at Basking Ridge
  • Memorial Sloan Kettering Monmouth
  • Memorial Sloan-Kettering Cancer Center at Commack
  • Memorial Sloan Kettering Westchester
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan-Kettering Cancer Center at Mercy Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Upfront Breast Surgery

Neoadjuvant Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

number of 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.

Secondary Outcome Measures

Full Information

First Posted
August 5, 2015
Last Updated
July 13, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02521363
Brief Title
Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer
Official Title
Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Implantable Microdevice, In Vivo Drug Sensitivity Testing, HER2-Positive, Triple Negative, 15-127

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Upfront Breast Surgery
Arm Type
Experimental
Arm Description
Patients will have the microdevice implanted prior to breast surgery, in the absence of neoadjuvant chemotherapy
Arm Title
Neoadjuvant Therapy
Arm Type
Experimental
Arm Description
Patients will have the device placed and retrieved on a core biopsy the following day, then receive neoadjuvant chemotherapy prior to definitive breast surgery.
Intervention Type
Device
Intervention Name(s)
KIBUR MICRODEVICE
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
anthracycline and taxane based chemotherapy
Intervention Description
Conventional, standard of care neoadjuvant chemotherapy delivered irrespective of device readout
Primary Outcome Measure Information:
Title
number of implantable devices
Description
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.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffany Traina, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering at Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center at Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

We'll reach out to this number within 24 hrs