Clinical Trials /

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

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:

Recruiting

Phase:

N/A

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

DrugSynonymsArms
anthracycline and taxane based chemotherapyNeoadjuvant Therapy

Purpose

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 Arms

NameTypeDescriptionInterventions
Upfront Breast SurgeryExperimentalPatients will have the microdevice implanted prior to breast surgery, in the absence of neoadjuvant chemotherapy
    Neoadjuvant TherapyExperimentalPatients 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: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

    November 22, 2017