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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02521363
Recruitment Status : Active, not recruiting
First Posted : August 13, 2015
Last Update Posted : June 22, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: KIBUR MICRODEVICE Drug: anthracycline and taxane based chemotherapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : July 2015
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Upfront Breast Surgery
Patients will have the microdevice implanted prior to breast surgery, in the absence of neoadjuvant chemotherapy
 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.
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02521363


Locations
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United States, New Jersey
Memorial Sloan-Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
United States, New York
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, United States, 11570
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Tiffany Traina, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02521363    
Other Study ID Numbers: 15-127
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: June 22, 2022
Last Verified: June 2022
Keywords provided by Memorial Sloan Kettering Cancer Center:
Implantable Microdevice
In Vivo Drug Sensitivity Testing
HER2-Positive
Triple Negative
15-127
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Hypersensitivity
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Immune System Diseases
Taxane
Antineoplastic Agents