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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: KIBUR MICRODEVICE; Drug: anthracycline and taxane based chemotherapy

• Registration Number: NCT02521363
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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 available

Study Timeline

• Study Start: 2015-07-24
• Study First Submitted: 2015-08-05
• Study First Submitted QC: 2015-08-10
• Study First Posted: 2015-08-13
• Status Verified: 2024-08
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
number of implantable devices	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.

Trial Locations

Locations (6)

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan-Kettering at Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan-Kettering Cancer Center at Commack; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan-Kettering Cancer Center at Mercy Medical Center; 🇺🇸 Rockville Centre, New York, United States