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



Status:Recruiting
Conditions:Breast Cancer, Cancer, Neurology
Therapuetic Areas:Neurology, Oncology
Healthy:No
Age Range:19 - Any
Updated:8/4/2018
Start Date:July 2015
End Date:July 2020
Contact:Tiffany Traina, MD
Phone:646-888-5209

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

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.


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
We found this trial at
6
sites
Basking Ridge, New Jersey 07920
Phone: 646-888-5209
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650 Commack Rd
Commack, New York 11725
(631) 623-4000
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Memorial Sloan-Kettering Cancer Center at Commack Memorial Sloan Kettering Cancer Center - the world's oldest...
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500 Westchester Avenue
Harrison, New York 10604
Phone: 646-888-5209
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Harrison, NY
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Middletown, New Jersey 07748
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-888-5209
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Rockville Centre, New York 11570
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Rockville Centre, NY
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