NCT02521363Completed
Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer
Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer
Source: ClinicalTrials.gov · Last updated 22 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 11 (actual)
- First submitted
- 5 Aug 2015
- Start date
- 24 Jul 2015
- Primary completion date
- 1 Aug 2024
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT02521363
What you commit to
- Study type: Interventional
- Participants enrolled: 11
- From 24 Jul 2015 to the primary completion date, 1 Aug 2024
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment including surgery, chemotherapy or radiation therapy for the current primary breast cancer.
Lab values
- 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
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: Female · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center at Commack Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Memorial Sloan Kettering Westchester Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Memorial Sloan Kettering Monmouth Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center at Mercy Medical Center Coordinator of this site? Confirm its status | Rockville Centre | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.