NCT05774886

Implantable Microdevice for TNBC - Pilot Study

Pilot Study of an Implantable Microdevice to Evaluate Drug Responses in Situ in Early-stage Triple-negative Breast Cancer

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

This is a single-arm, pilot research study to evaluate the safety and feasibility of using an implantable microdevice to measure local intratumoral response to chemotherapy and other clinically relevant drugs in triple-negative breast cancer (TNBC). A pilot study means that this is the first time investigators are examining this study intervention in TNBC. Participants selected for this study must have a diagnosis of Stage II-III TNBC and are scheduled to undergo neoadjuvant systemic therapy. This study involves implanting 2 microdevices, each small enough to fit inside the tip of a needle, into a tumor. The microdevices will release microdoses of up to 30 different cancer drugs via passive diffusion. The drugs will only penetrate the local tumor tissues. After approximately 72 hours, the microdevices and small regions of surrounding tissue will be removed and studied. The U.S. Food and Drug Administration (FDA) has not approved the microdevice as treatment for any disease. For this study, the drugs used are agents approved by the U.S. FDA for the treatment of different types of cancer. The research study procedures include screening for eligibility, study treatment with evaluations, radiology scans of tumors, blood tests, tumor biopsies, mammograms, and follow-up visits. It is expected that about 24 people will take part in this research study. Participants will be followed on this study for up to 3 years.

Conditions

• Triple Negative Breast Cancer
• Breast Cancer Stage II
• Breast Cancer Stage III
• Breast Cancer
• Early Stage Triple-Negative Breast Carcinoma
• Breast Neoplasms
• Breast Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-09-01
• Completion: 2028-09-01
• First posted: 2023-03-20
• Last updated: 2023-05-18

Regulatory

• FDA-regulated drug study
• FDA-regulated device study