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Implantable Microdevice for TNBC - Pilot Study

NCT05774886 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-05-18

No results posted yet for this study

Summary

The goal of this research study is to evaluate the safety and feasibility of implanting and retrieving a microdevice that releases microdoses of a specific drug or combination of drugs as a possible tool to evaluate the effectiveness of several cancer drugs against early stage Triple Negative Breast Cancer (TNBC).

The name of the intervention involved in this study is:

Implantable Microdevice (IMD)

Conditions

Interventions

COMBINATION_PRODUCT

Implantable Microdevice (IMD)

* Small, implantable device with 30 reservoirs for drug and drug combinations. * Placement of 2 microdevices into tumor will be performed via needle, percutaneously, and guided by interventional radiologic techniques. * Drugs include all or a subset of the following: Doxorubicin, Paclitaxel, Carboplatin, Eribulin, Pembrolizumab, Atezolizumab, Tazemetostat, Panobinostat, Olaparib, Capecitabine, Sacituzumab govitecan, Abemaciclib, Venetoclax, Doxorubicin + cyclophosphamide (combination), Doxorubicin + cyclophosphamide + paclitaxel + carboplatin (combination), Carboplatin + paclitaxel (combination), Doxorubicin + cyclophosphamide + pembrolizumab (combination), Doxorubicin + cyclophosphamide + paclitaxel + carboplatin + Pembrolizumab (combination), Paclitaxel + atezolizumab (combination), Paclitaxel + pembrolizumab (combination), Carboplatin + gemcitabine + pembrolizumab (combination), Carboplatin + paclitaxel + pembrolizumab (combination), Trastuzumab deruxtecan

Sponsors & Collaborators

Principal Investigators

  • Ana Garrido-Castro, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2023-09-01
Completion
2028-09-01
FDA Drug
Yes
FDA Device
Yes

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05774886 on ClinicalTrials.gov