A Phase 1 interventional study of Implantable Microdevice (IMD) in Triple Negative Breast Cancer, Breast Cancer Stage II and Breast Cancer Stage III, sponsored by Dana-Farber Cancer Institute. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-18.
Sponsored by Dana-Farber Cancer Institute · Phase 1, Interventional, and Treatment
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)
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.
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Participants will undergo laboratory testing within 7 days prior to the microdevice placement. Participants must have normal coagulation and marrow function as defined below:
Exclusion Criteria:
* 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)
* 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
Number of Participants with Adverse Events
Defined by assessment of adverse events as defined by CTCAE v5.0.
Time frame: 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.
Time frame: up to 80 hours
Local Intratumoral Response (per Apoptosis)
Descriptive statistics will be used to summarize the quantitative measurement of apoptosis (apoptotic index) for drug-treated regions compared to untreated regions of the device.
Time frame: up to 80 hours
Local Intratumoral Response (per Proliferation)
Descriptive statistics will be used to summarize the quantitative measurement of proliferation (Ki67) for drug-treated regions compared to untreated regions of the device.
Time frame: up to 80 hours
Response to Systemic Neoadjuvant Therapy (RCB Class)
Correlation between local intratumoral response with the microdevice and response to systemic neoadjuvant therapy will be evaluated. Clinical response to systemic neoadjuvant therapy will be defined using residual cancer burden (RCB) class.
Time frame: up to 3 years
Response to Systemic Neoadjuvant Therapy (RCB Score)
Correlation between local intratumoral response with the microdevice and response to systemic neoadjuvant therapy will be evaluated. Clinical response to systemic neoadjuvant therapy will be defined using RCB score.
Time frame: up to 3 years
Invasive disease-free survival
Correlation between local intratumoral response with the microdevice and invasive disease-free survival, defined as the time from registration until the occurrence of local/regional recurrence, contralateral invasive breast cancer, distant recurrence, second primary invasive non-breast cancer, or death due to any cause or censored at date of last disease evaluation.
Time frame: up to 3 years
Overall survival
Correlation between local intratumoral response with the microdevice and overall survival, defined as the time from registration until death due to any cause or censored at the date of last known alive.
Time frame: up to 3 years
No study locations are listed for this record.
Plan to share: Yes — The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is withdrawn, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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