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Triple Negative Breast CancerPhase 1NCT05774886

Implantable Microdevice for TNBC - Pilot Study

A Phase 1 study testing Implantable Microdevice (IMD) in people with Triple Negative Breast Cancer and Breast Cancer Stage II, run by Dana-Farber Cancer Institute.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Implantable Microdevice (IMD)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
May 2023to 1 Sep 2028
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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
  • Platelets ≥ 75,000/mcL
  • PT (INR) < 1.5
  • PTT < 1.5 x control
  • Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior registration. Childbearing potential is defined as: participants who have not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause) and have not undergone surgical sterilization (removal of ovaries and/or uterus).
  • Patients must have the ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • 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.)

About this study

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

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)

Read the 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.

Being tested
Implantable Microdevice (IMD)
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
Medical subject headings
Triple Negative Breast Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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
Study groups in NCT05774886
Study groupRoleWhat they receive
IMD Placement and RetrievalExperimental* 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.
Receives: Combination Product: Implantable Microdevice (IMD)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse Events

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

    Measured: up to 80 hours

  2. 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.

    Measured: up to 80 hours

Secondary outcomes (6)

  1. 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.

    Measured: up to 80 hours

  2. 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.

    Measured: up to 80 hours

  3. 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.

    Measured: up to 3 years

  4. 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.

    Measured: up to 3 years

  5. 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.

    Measured: up to 3 years

  6. 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.

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2023
  2. Study startMay 2023 (estimated)
  3. Primary completion1 Sep 2023 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Why it stopped: On hold

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05774886
Sponsor's protocol ID
22-508
Status last verified
May 2023
First submitted
31 Jan 2023
Last updated
18 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Implantable Microdevice (IMD) in people with Triple Negative Breast Cancer and Breast Cancer Stage II, run by Dana-Farber Cancer Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (time frame: up to 80 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05774886.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.

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Implantable Microdevice for TNBC - Pilot Study | AzTrials