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IMD Placement and Retrieval for Breast Cancer

Phase 1
Waitlist Available
Led By Ana Garrido-Castro, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial will evaluate the safety and feasibility of implanting a microdevice to deliver microdoses of cancer drugs to assess effectiveness against TNBC.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Adverse Events
Number of Participants with Successful Procedure
Secondary outcome measures
Invasive disease-free survival
Local Intratumoral Response (per Apoptosis)
Local Intratumoral Response (per Proliferation)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: IMD Placement and RetrievalExperimental Treatment1 Intervention
Participants with confirmed anatomic stage II-III TNBC whose planned treatment includes neoadjuvant systemic therapy with the intention to undergo surgery, including breast and/or axillary surgery, will be selected for study participation. Participants will undergo image-guided placement of 2 microdevices within a single lesion. Participants will undergo image-guided retrieval of the microdevices (and surrounding tissue) approximately 72 hours after placement. Participants will be monitored for safety endpoints and clinical data will be collected for the duration of the study.

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Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,948 Total Patients Enrolled
141 Trials studying Breast Cancer
22,617 Patients Enrolled for Breast Cancer
Ana Garrido-Castro, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
110 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacant opportunities for people to participate in this research project?

"According to clinicaltrials.gov, recruitment for this trial has ceased since the last update on March 8th 2023. However, there are currently 4934 other medical trials looking for participants."

Answered by AI

What adverse effects could arise from IMD Placement and Retrieval?

"Due to the preliminary nature of this clinical trial, our team at Power rated IMD Placement and Retrieval's safety a 1 out of 3. At present, there is only limited data supporting its efficacy and safety profiles."

Answered by AI

What objectives are researchers trying to achieve with this research endeavor?

"This trial will last up to 80 hours and the primary objective is to track how many participants have a successful procedure. Secondly, there are two additional objectives: correlating local intratumoral response with the microdevice and systemic neoadjuvant therapy (RCB Class) using descriptive statistics; as well as tracking response to systemic neoadjuvant therapy through RCB Score."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Dana Farber Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Implantable Microdevice for TNBC - Pilot Study
Ana C Garrido-Castro, MD 2023. "Implantable Microdevice for TNBC - Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05774886.
~0 spots leftby Apr 2025
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