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
1 other identifier
interventional
11
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Jul 2015
Longer than P75 for not_applicable breast-cancer
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 24, 2015
CompletedFirst Submitted
Initial submission to the registry
August 5, 2015
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedResults Posted
Study results publicly available
August 22, 2025
CompletedAugust 22, 2025
August 1, 2024
9 years
August 5, 2015
July 10, 2025
August 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With 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.
Up to 1 year
Study Arms (2)
Upfront Breast Surgery
EXPERIMENTALPatients will have the microdevice implanted prior to breast surgery, in the absence of neoadjuvant chemotherapy
Neoadjuvant Therapy
EXPERIMENTALPatients will have the device placed and retrieved on a core biopsy the following day, then receive neoadjuvant chemotherapy prior to definitive breast surgery.
Interventions
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.
Conventional, standard of care neoadjuvant chemotherapy delivered irrespective of device readout
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Memorial Sloan-Kettering at Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, 11570, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Tiffany Traina, MD
- Organization
- Memorial Sloan Kettering Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Tiffany Traina, MD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2015
First Posted
August 13, 2015
Study Start
July 24, 2015
Primary Completion
August 1, 2024
Study Completion
August 1, 2024
Last Updated
August 22, 2025
Results First Posted
August 22, 2025
Record last verified: 2024-08