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Chemotherapy
Implantable Microdevice Drug Sensitivity Test for Breast Cancer
N/A
Waitlist Available
Led By Tiffany Traina, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Tumor size 2cm or greater; N any; M0
Patients with histologically confirmed invasive breast cancer that is: Triple negative (ER<10%, PR<10%, and HER2 0/1+ or 2+/FISH not amplified)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a device that could help predict the best treatment for an individual's breast cancer.
Who is the study for?
This trial is for adults over 18 with early-stage, HER2-positive or triple-negative breast cancer who haven't had surgery, chemo, or radiation yet. They should be fit enough for chemotherapy and curative surgery, have a tumor size of at least 1cm (or 2cm depending on the cohort), and not be pregnant if of childbearing potential.Check my eligibility
What is being tested?
The study tests the safety of using an implantable microdevice in patients' tumors to predict which treatments might work best. Participants will either get this device before standard preoperative chemo or just before their planned breast surgery.See study design
What are the potential side effects?
Potential side effects are not detailed but may include typical reactions to having a foreign device implanted temporarily in the body such as discomfort, infection risk at the site, and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor is at least 2cm big and has not spread to distant parts of my body.
Select...
My breast cancer is triple negative.
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I am older than 18 years.
Select...
My tumor is at least 1cm big, and it hasn't spread to distant parts of my body.
Select...
My tumor is at least 2cm big, and it hasn't spread to distant parts of my body.
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I am eligible for surgery aimed at curing my breast cancer.
Select...
I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
number of implantable devices
Trial Design
2Treatment groups
Experimental Treatment
Group I: Upfront Breast SurgeryExperimental Treatment1 Intervention
Patients will have the microdevice implanted prior to breast surgery, in the absence of neoadjuvant chemotherapy
Group II: Neoadjuvant TherapyExperimental Treatment2 Interventions
Patients will have the device placed and retrieved on a core biopsy the following day, then receive neoadjuvant chemotherapy prior to definitive breast surgery.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,609 Total Patients Enrolled
202 Trials studying Breast Cancer
81,126 Patients Enrolled for Breast Cancer
Tiffany Traina, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
695 Total Patients Enrolled
5 Trials studying Breast Cancer
494 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor is at least 2cm big and has not spread to distant parts of my body.I have had surgery, chemotherapy, or radiation for my current breast cancer.My breast cancer is triple negative.I am older than 18 years.Women who could become pregnant need to have a negative pregnancy test within 2 weeks before joining the study.My tumor is at least 1cm big, and it hasn't spread to distant parts of my body.My tumor is at least 2cm big, and it hasn't spread to distant parts of my body.I am eligible for surgery aimed at curing my breast cancer.I am eligible for initial treatment with a specific chemotherapy before surgery.I can take care of myself but might not be able to do heavy physical work.
Research Study Groups:
This trial has the following groups:- Group 1: Upfront Breast Surgery
- Group 2: Neoadjuvant Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How widely is this clinical investigation being conducted across Canada?
"Currently, 6 clinics are administering this trial. Sites in Rockville Centre, Basking Ridge and Middletown have been identified alongside 3 other locales. Choosing the clinic nearest to you will reduce your time spent travelling if successful enrollment occurs."
Answered by AI
Are any fresh participants being signed up for this experiment at the moment?
"Contrary to what is indicated on clinicaltrials.gov, this medical trial has ceased its recruitment of candidates since June 20th 2022. The study was first posted July 1st 2015 but there are now 2,920 other trials seeking new participants."
Answered by AI
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