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

• ClinicalTrials.gov Identifier: NCT02521363
• Recruitment Status: Active, not recruiting
• First Posted: August 13, 2015
• Last Update Posted: June 22, 2022
• Sponsor: Memorial Sloan Kettering Cancer Center
• Information provided by (Responsible Party): Memorial Sloan Kettering Cancer Center

Tracking Information

• First Submitted Date: August 5, 2015
• First Posted Date: August 13, 2015
• Last Update Posted Date: June 22, 2022
• Study Start Date: July 2015
• Estimated Primary Completion Date: July 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 10, 2015)

number of implantable devices [ Time Frame: 1 year ]

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Breast Cancer

Intervention

• Device: KIBUR MICRODEVICE
  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.
• Drug: anthracycline and taxane based chemotherapy
  Conventional, standard of care neoadjuvant chemotherapy delivered irrespective of device readout

Study Arms

• Experimental: Upfront Breast Surgery
  Patients will have the microdevice implanted prior to breast surgery, in the absence of neoadjuvant chemotherapy
  Intervention: Device: KIBUR MICRODEVICE
• Experimental: Neoadjuvant Therapy
  Patients will have the device placed and retrieved on a core biopsy the following day, then receive neoadjuvant chemotherapy prior to definitive breast surgery.
  Interventions:

  • Device: KIBUR MICRODEVICE
  • Drug: anthracycline and taxane based chemotherapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: June 17, 2019): 11
• Original Estimated Enrollment (submitted: August 10, 2015): 12
• Estimated Study Completion Date: July 2023
• Estimated Primary Completion Date: July 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02521363
• Other Study ID Numbers: 15-127
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Memorial Sloan Kettering Cancer Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Memorial Sloan Kettering Cancer Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Tiffany Traina, MD; Memorial Sloan Kettering Cancer Center

• PRS Account: Memorial Sloan Kettering Cancer Center
• Verification Date: June 2022