New combo therapy aims to wipe out breast cancer before surgery
NCT ID NCT07102940
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding an immune-boosting drug called eftilagimod alpha to standard chemotherapy before surgery can completely eliminate tumors in people with early-stage hormone receptor-positive, HER2-negative breast cancer. About 50 participants will receive the drug combination, and researchers will check the removed tissue for any remaining cancer cells. The goal is to improve the chance of a complete response, which may reduce the risk of the cancer coming back.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Have histologically documented HR+/HER2 neg (defined as ER expression \>10% by IHC and/or PR expression \> 10% by IHC and HER2 0 or 1+ or 2+ by IHC or FISH ratio \<2 or HER2 gene copy number of \<6). * Clinical early-stage breast cancer (Stage I-III) and a candidate for NAC. * Be informed of the investigational nature of the trial and all pertinent aspects of the trial. * Have ECOG performance status of 0-2. * Have the ability to understand and the willingness to sign a written informed -consent document in accordance with institutional and federal guidelines. * Be ≥ 21 years of age. * Have serum creatinine \< 1.5 x institutional upper limit of normal (IULN) or a calculated creatinine clearance ≥ 30ml/min (calculated by Cockcroft Gault equation), bilirubin ≤ 2.0, and an SGOT/SGPT/alkaline phosphatase ≤ 2.0 x IULN. * Have adequate bone marrow function (ANC \>1000/μL, Platelets \>100,000/ml, Hemoglobin \>10gm/dL). * Women of childbearing potential or male patients of reproductive potential with female partners of childbearing potential must not consider getting pregnant and must avoid pregnancy during the trial and for at least 6 months after the last dose of trial treatment. Female and male patients of reproductive potential must practice highly effective methods of contraception with their partners, if of reproductive potential, during treatment and for 6 months following last dose of treatment with IP. Exclusion Criteria: * Receiving concurrent anti-neoplastic therapy for another malignancy * Known documented or suspected hypersensitivity to the components of the trial drug or analogs. * Stage IV or patients otherwise not indicated for surgery. Patients with oligometastatic disease who are undergoing curative intent treatment are eligible as long as curative intent surgery is planned. * A woman of child-bearing potential who has a positive serum pregnancy test (within 72 hours) prior to Day 1. * Breastfeeding * Serious infection within 4 weeks prior to Day 1 or active acute or chronic infection needing IV antibiotics. Note: Subjects treated for moderately severe infections with oral antibiotics only, may be included, based on consultation with trial Investigator. * Evidence of severe or uncontrolled cardiac disease within 6 months prior to first dose of trial treatment including: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 5.0 Grade ≥ 2, atrial fibrillation \> grade 2 not controlled by a pacemaker, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (NYHA III-IV), cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism. * Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. * Receives continuous systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days prior to Day 1. Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalents are permitted in the absence of active auto-immune disease. * Live vaccine within 30 days of planned Day 1. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Note: non-live vaccines (e.g., non-live influenza vaccine, non-live COVID-19 vaccine) can be given until 3 days prior to planned Day 1. * Prior anti-LAG-3 therapy (e.g. anti-LAG-3 antibodies). * Prior high-dose chemotherapy requiring hematopoietic stem cell rescue. * Has had an allogenic tissue/solid organ transplant.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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