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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: anthracycline and taxane based chemotherapy; Device: KIBUR MICRODEVICE

Study type: Interventional

Funder types: Other

Identifiers

NCT02521363

15-127

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: Female

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Upfront Breast Surgery

Experimental group

Description:

Patients will have the microdevice implanted prior to breast surgery, in the absence of neoadjuvant chemotherapy

Treatment:

Device: KIBUR MICRODEVICE

Neoadjuvant Therapy

Experimental group

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.

Treatment:

Device: KIBUR MICRODEVICE

Drug: anthracycline and taxane based chemotherapy