Clinical trial NCT02521363: Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer
Official title: Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Implantable Microdevice
In Vivo Drug Sensitivity Testing
HER2-Positive
Triple Negative
15-127
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 11
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: number of implantable devices
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan-Kettering at Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan-Kettering Cancer Center at Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Tiffany Traina, MD
role: PRINCIPAL_INVESTIGATOR
References: