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

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