Implantable Microdevice for TNBC - Pilot Study

NCT05774886 | Withdrawn Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: 22-508
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

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

Keywords

Triple Negative Breast Cancer; Breast Cancer Stage II; Breast Cancer Stage III; Breast Cancer; Early Stage Triple-Negative Breast Carcinoma; Breast Neoplasms; Breast carcinoma

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Adverse Events

  Defined by assessment of adverse events as defined by CTCAE v5.0.

  up to 80 hours

• Number of Participants with Successful Procedure

  Defined as the ability to retrieve two implanted microdevices with sufficient tissue, of sufficient quality, for downstream histopathology analysis and interpretation of at least 67% of the microdevice reservoirs in each device.

  up to 80 hours

Secondary Outcomes (6)

• Local Intratumoral Response (per Apoptosis)

  up to 80 hours

• Local Intratumoral Response (per Proliferation)

  up to 80 hours

• Response to Systemic Neoadjuvant Therapy (RCB Class)

  up to 3 years

• Response to Systemic Neoadjuvant Therapy (RCB Score)

  up to 3 years

• Invasive disease-free survival

  up to 3 years

Study Arms (1)

IMD Placement and Retrieval

EXPERIMENTAL

* 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.

Combination Product: Implantable Microdevice (IMD)

Interventions

Implantable Microdevice (IMD) COMBINATION_PRODUCT

* 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

IMD Placement and Retrieval

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have histologically or cytologically confirmed invasive breast cancer.
• Anatomic stage II-III breast cancer per AJCC 8th edition classification system. Primary breast tumor must be at least 2 cm in size (per imaging and/or physical exam). Participants must be considered candidates for neoadjuvant systemic therapy with the intention to undergo surgery (breast +/- axillary).
• Estrogen-receptor and progesterone-receptor expression both \<10% by immunohistochemistry (IHC), and HER2-negative status as determined by the current ASCO/CAP guidelines.
• Participant must agree to undergo the percutaneous procedures for implantation and removal of the microdevice.
• Participant must be evaluated by a surgeon and/or medical oncologist who will determine the clinically appropriate treatment strategy based on clinical history and extent of disease. Participant must be deemed medically fit to undergo the percutaneous procedures for microdevice implantation and removal.
• Participant must have a primary breast tumor that is considered amenable to percutaneous placement and removal of the microdevice. Participants with history of prior malignancy (invasive or in situ) in the ipsilateral breast are not eligible.
• Patients with multifocal or multicentric disease are eligible, if not known to be HER2-positive. Pathologic confirmation of multifocal or multicentric is at physician´s discretion; however, if pathologic confirmation is obtained, receptor status must be available prior to registration.
• Patients with bilateral breast cancers are eligible, if not known to be HER2-positive. Pathologic confirmation of bilateral breast cancer is at physician´s discretion; however, if pathologic confirmation is obtained, receptor status must be available prior to registration.
• Prior systemic therapy: No prior chemotherapy, biologic therapy, hormonal therapy or investigational therapy for this breast cancer.
• Prior radiation therapy: No prior radiation to the ipsilateral breast.
• Prior surgery: No prior surgery to the ipsilateral breast.
• The subject is ≥ 18 years old.
• ECOG performance status ≤ 2 (Appendix A).
• Participants will undergo laboratory testing within 7 days prior to the microdevice placement. Participants must have normal coagulation and marrow function as defined below:
• Absolute neutrophil count ≥ 1,500/mcL

You may not qualify if:

• Uncontrolled, significant intercurrent or recent illness including, but not limited to, ongoing or active infection, uncontrolled non-malignant systemic disease, uncontrolled seizures, or psychiatric illness/social situation that would limit compliance with study requirements in the opinion of the treating investigator.
• Prior hypersensitivity to any of the study drugs implanted with the device.
• Pregnant women are excluded from this study because of the possible increased dose of radiation from imaging associated with the device placement (e.g., if placement cannot be performed guided by ultrasound or MRI, if additional imaging and/or procedures are required due to potential complication of the device placement or removal).
• Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or percutaneous biopsy procedures.
• Significant risk factors (including, but not limited to, high risk of venous thrombosis, pulmonary embolism, stroke, or myocardial infarction) precluding the safe cessation of anticoagulation medication as per Radiology guidelines. (Patients taking low-dose aspirin only do not need to be excluded.)

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ana Garrido-Castro, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: March 20, 2023
• Study Start: May 1, 2023
• Primary Completion: September 1, 2023
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu