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Pilot Study of Dupilumab, Pembrolizumab, Paclitaxel, and Carboplatin for Triple Negative Breast Cancer

This study is testing a new combination of treatments for locally advanced triple-negative breast cancer (TNBC). It combines dupilumab, an immunotherapy drug approved for conditions like eczema, with pembrolizumab, another immunotherapy approved for TNBC, and two standard chemotherapy drugs, paclitaxel and carboplatin. Researchers want to see how safe this combination is, especially looking for severe immune-related side effects. They also want to see how well the treatment shrinks tumors and if it helps prevent the cancer from coming back. You may be able to join if you have newly diagnosed, localized TNBC that is at least 2 centimeters or has spread to nearby lymph nodes. The study plans to enroll 15 participants.

Study design
This is a pilot study, meaning it's an early-stage investigation, and it will involve 15 participants. It is an interventional study, meaning participants will receive specific treatments.
What's involved
Participants will receive dupilumab and pembrolizumab every 3 weeks for 4 cycles, and paclitaxel and carboplatin weekly for 12 weeks. The study will monitor for severe immune-related side effects within 4 months of therapy.
Compensation
Not stated in the trial record.
Follow-up
The study will measure severe immune-related adverse events within 4 months of therapy. Recurrence-free survival and overall survival will also be estimated, suggesting longer-term follow-up.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06637306

Neoadjuvant Dupilumab, Pembrolizumab, Paclitaxel, and Carboplatin in Locally Advanced Triple Negative Breast Cancer

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Rima Patel
~15 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:DupilumabPembrolizumabPaclitaxelCarboplatin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of severe immune-related adverse events (irSAE)
Measured over Within 4 months of therapy

Conditions

Locally Advanced Triple Negative Breast Cancer
TNBC - Triple-Negative Breast Cancer

Explore related trials

Triple-negative breast cancer

NCT06637306

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mount Sinai Health System

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Rima Patel, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
  • Joseph Sparano, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Rima Patel, MD
[email protected]
(212) 604-6010
Email the study team

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Eligibility criteria

Inclusion

Patients with pathologically confirmed diagnosis of triple negative breast cancer, as defined by the most recent ASCO/CAP guidelines.
Patients must have previously untreated, localized TNBC with either tumor size ≥ 2 centimeters (T2-4N0) or lymph node involvement with at least a 1cm tumor (T1c-T4N1-3).
Patients must have previously untreated disease with no prior definitive breast surgery, radiation therapy, or systemic chemotherapy with therapeutic intent for this breast cancer.
Patients must be eligible to receive chemotherapy agents in the study including paclitaxel and carboplatin.
Patients must be willing and able to provide blood samples at the time points indicated in the study calendar.
Patients must be willing and able to have core needle biopsies of tumor prior to initiation of treatment. Should patients undergo pre-treatment or on-treatment biopsy procedure and inadequate number of biopsies are obtained, they may proceed with initiation/continuation of treatment at the discretion of the investigator and treating physician.
Age ≥ 18 years.
ECOG performance status 0-1.
Adequate organ and marrow function as defined below:
absolute neutrophil count ≥ 1,500/mcL
platelets ≥ 100,000/mcl
total bilirubin within normal institutional limits
AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal
creatinine within normal institutional limits
Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Ability to understand and the willingness to sign a written informed consent.

Exclusion

Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or any treatment with therapeutic intent for the breast cancer.
Patients may not be receiving any other investigational agents.
Patients who have any distant metastases and considered to have Stage IV disease.
Patients who have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Patients on chronic steroids (more than 4 weeks at stable dose) equivalent to ≤ 10mg prednisone will not be excluded.
Patients with active autoimmune disease that has required systemic treatment in the past 1 year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is acceptable.
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin, paclitaxel, dupilumab or pembrolizumab used in study. Documented allergic or hypersensitivity response to any protein therapeutics (e.g., recombinant proteins, vaccines, intravenous immune globulins, monoclonal antibodies, receptor traps).
HIV positive with detectable viral load, or anyone not on stable anti-viral (HAART) regimen, or with \<350 CD4+ T cells/microliter in the peripheral blood.
Known active Hepatitis B (e.g., HBV detected by PCR or active Hepatitis C (e.g., HCV RNA \[qualitative\] is detected). Patients with hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA. Patients must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.
Known, untreated helminth infections. Patients with prior history of a helminth infection who were fully treated are permitted.
History of allogeneic hematopoietic cell transplantation or solid organ transplantation.
Receipt of a live vaccine within 30 days of planned start of study medication.
History of irAE in response to prior immunotherapy that has not improved to a Grade 0 or 1; this does not include chronic conditions such as endocrinopathies which can be treated with hormone replacement therapy.
History of interstitial lung disease (e.g., idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis attributed to prior use of cancer immunotherapy that required immune-suppressive doses of glucocorticoids to assist with management. History of radiation pneumonitis treated with glucocorticoids.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

What this trial measures

  • Incidence of severe immune-related adverse events (irSAE)Within 4 months of therapy

    Incidence of severe immune-related adverse events within 4 months of therapy. Immune related Severe Adverse Events (irSAE) are defined as: * Any Grade 4 immune-related AE with the exception of hypothyroidism * Any Grade 3 immune-related AE requiring permanent discontinuation of dupilumab and pembrolizumab * Any new Grade 3 or Grade 4 non-hematologic laboratory abnormality, if * medical intervention is required, or * the abnormality leads to hospitalization, or * the abnormality persists for \> 72 hours * Any non-hematologic AE which is considered severe or life-threatening and requires discontinuation of dupilumab and pembrolizumab * Any ≥ Grade 2 immune-mediated uveitis * Any immune-related AE resulting in persistent or significant disability/incapacity (substantial disruption of one's ability to conduct normal life functions) for a period of 30 days or greater * Grade 5 or life-threatening toxicity