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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02521363

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

1.8

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Device: KIBUR MICRODEVICE Drug: anthracycline and taxane based chemotherapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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 Start Date :

Jul 1, 2015

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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

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

Drug: anthracycline and taxane based chemotherapy

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

Outcome Measures

Primary Outcome Measures

number of implantable devices [1 year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan-Kettering at Basking Ridge	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan Kettering Monmouth	Middletown	New Jersey	United States	07748
3	Memorial Sloan-Kettering Cancer Center at Commack	Commack	New York	United States	11725
4	Memorial Sloan Kettering Westchester	Harrison	New York	United States	10604
5	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
6	Memorial Sloan-Kettering Cancer Center at Mercy Medical Center	Rockville Centre	New York	United States	11570