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

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02521363

Run by

Memorial Sloan Kettering Cancer Center

People needed

11

Starts

2015-07-24

Expected to finish

2024-08-01

Last updated by the study team

2025-08-22

Who can join

Age: 19 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Memorial Sloan-Kettering at Basking Ridge — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth — Middletown, 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 Cancer Center — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center at Mercy Medical Center — Rockville Centre, New York, United States

Full record on ClinicalTrials.gov

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