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

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: KIBUR MICRODEVICE
* Drug: anthracycline and taxane based chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Upfront Breast Surgery<br>Patients will have the microdevice implanted prior to breast surgery, in the absence of neoadjuvant chemotherapy | Device: KIBUR MICRODEVICE<br>* 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.<br>|
| Experimental: Neoadjuvant Therapy<br>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<br>* 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.<br>Drug: anthracycline and taxane based chemotherapy<br>* Conventional, standard of care neoadjuvant chemotherapy delivered irrespective of device readout<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implantable Microdevice, In Vivo Drug Sensitivity Testing, HER2-Positive, Triple Negative, 15-127