Clinical Trial: NCT02521363 - My Cancer Genome

NCT02521363

Description:

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.

Related Conditions:

Breast Carcinoma

Recruiting Status:

Active, not recruiting

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT02521363

Trial Eligibility

Document

Title

Brief Title: 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

Clinical Trial IDs

ORG STUDY ID: 15-127
NCT ID: NCT02521363

Conditions

Breast Cancer

Interventions

Drug	Synonyms	Arms
anthracycline and taxane based chemotherapy		Neoadjuvant Therapy

Purpose

Trial Arms

Name	Type	Description	Interventions
Upfront Breast Surgery	Experimental	Patients will have the microdevice implanted prior to breast surgery, in the absence of neoadjuvant chemotherapy
Neoadjuvant Therapy	Experimental	Patients will have the device placed and retrieved on a core biopsy the following day, then receive neoadjuvant chemotherapy prior to definitive breast surgery.	anthracycline and taxane based chemotherapy

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

Maximum Eligible Age:	N/A
Minimum Eligible Age:	19 Years
Eligible Gender:	Female
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	number of implantable devices
Time Frame:	1 year
Safety Issue:
Description:	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.

Details

Phase:	N/A
Primary Purpose:	Interventional
Overall Status:	Active, not recruiting
Lead Sponsor:	Memorial Sloan Kettering Cancer Center

Trial Keywords

Implantable Microdevice
In Vivo Drug Sensitivity Testing
HER2-Positive
Triple Negative
15-127

Last Updated

June 21, 2021

Clinical Trials /

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