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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02521363
• Other study ID #: 15-127
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2015
• Est. completion date: July 2026

Study information

• Verified date: July 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Hypersensitivity
• Triple Negative Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering at Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan-Kettering Cancer Center at Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan-Kettering Cancer Center at Mercy Medical Center	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center