Breast CancerPhase 2NCT07102940

Efti in Patients With Hormone Receptor Positive/HER2-neg Breast Cancer

A Phase 2 study testing Eftilagimod Alfa (Efti), Docetaxel-cyclophosphamide (TC) intravenous (i.v) and Dose dense Adriamycin-cyclophosphamide (AC) i.v in people with Breast Cancer and HER 2 Negative Breast Cancer, run by George Washington University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Breast Cancer, HER 2 Negative Breast Cancer, HR Positive/HER-2 Negative Breast Cancer
What is being tested?: Eftilagimod Alfa (Efti), Docetaxel-cyclophosphamide (TC) intravenous (i.v) and Dose dense Adriamycin-cyclophosphamide (AC) i.v
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: No sites listed yet
Study dates: 1 Sep 2026to Aug 2028
Phase: Phase 2
Are there results?: Not yet: the study is under way

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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 9Show fewer

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.

Who cannot join

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.

Show all 13Show fewer

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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Pavani Chalasani, MD contact

202-741-2277

pchalasani@mfa.gwu.edu

Richard Lush, PhD contact

rmlush3@gwu.edu

About this study

Official title: Eftilagimod Alpha in Combination With Neoadjuvant Chemotherapy in Patients With Hormone Receptor Positive/HER2-neg Breast Cancer

The goal of this interventional study is to determine pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) and Efti treatment. This is a prospective single arm interventional trial in patients with early-stage HR+/HER2 -ve breast cancer (Stage I-III) who are eligible for neoadjuvant chemotherapy (NAC). Enrolled patients will be treated with single agent efti for 3 weeks and then start NAC in combination with efti. There are 2 standard NAC usually used and will be determined by treating physician prior to starting on this trial.

Conditions: Breast Cancer, HER 2 Negative Breast Cancer, HR Positive/HER-2 Negative Breast Cancer, Stage 1-3
Being tested: Eftilagimod Alfa (Efti), Docetaxel-cyclophosphamide (TC) intravenous (i.v), Dose dense Adriamycin-cyclophosphamide (AC) i.v
Keywords: breast, cancer, HER2, HR positive
Medical subject headings: Breast Neoplasms, Neoplasms

What participants receive

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

Eftilagimod Alfa (Efti)Drug
Eftilagimod Alfa (Efti) will be administered subcutaneously at a dose of 30 mg beginning of week 1 of the trial for a total of 3 doses (week 1, 2 and 3). After 3 weeks, efti will be administered starting with week 4, every 2 weeks and combined with either TC or AC
Docetaxel-cyclophosphamide (TC) intravenous (i.v)Drug
TC will be administered at docetaxel 75mg/m2 IV and cyclophosphamide 600mg/m2 IV every 3 weeks for a total of 4 administrations starting on week 4 of the trial (weeks 4, 7,10, and 13).
Docetaxel is administered over 60min (dilute in 250 mL NS or D5W to a final concentration of 0.3 to 0.74 mg/mL and administer over 60 minutes).
Cyclophosphamide is administered over 30-60min (dilute in 250 to 500 mL NS or D5W and administer over 30 to 60 minutes after docetaxel).
G-CSF support for TC is per institutional SOC guidelines. Efti is to be given always ≥ 30 minutes after TC is finished if both regimens are administered the same day.
Dose dense Adriamycin-cyclophosphamide (AC) i.vDrug
AC will be administered at doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 IV every 2 weeks for a total of 4 administrations starting week 4 of the trial (weeks 4, 6, 8 and 10):
Doxorubicin is administered over 5 min (Dilute with NS to a final concentration of 2 mg/mL and administered as an IV bolus over three to five minutes into a free flowing IV infusion of NS or D5W).
Cyclophosphamide is administered over 30-60min (Dilute in 250 to 500 mL NS or D5W and administer over 30 to 60 minutes).
G-CSF support is per SOC/institutional guidelines.
Paclitaxel is given weekly for a period of 12 weeks (weeks 12 to 23) at 80mg/m2 (Dilute with 250 to 500 mL NS or D5W (final concentration of 0.3 to 1.2 mg/mL) and administered per institutional guidelines). Alternatively nab-paclitaxel weekly can be used (if paclitaxel cannot be used due to allergic reaction).
Efti is to be given always ≥ 30 minutes after AC or paclitaxel is finished if both regimens are administered the same day.

Study groups in NCT07102940
Study group	Role	What they receive
Efti + NAC Regimens	Experimental	Eftilagimod Alfa (Efti) will be administered subcutaneously at a dose of 30 mg beginning of week 1 of the trial for a total of 3 doses (week 1, 2 and 3). After 3 weeks, efti will be administered starting with week 4, every 2 weeks and combined with either TC or AC. NAC regimens: * Docetaxel-cyclophosphamide (TC) intravenous (i.v) every 3 weeks (q3w) x 4, or * Dose dense Adriamycin-cyclophosphamide (AC) i.v q2w x 4 followed by weekly paclitaxel IV X12 weeks (alternatively weekly nab-paclitaxel can be used per physician's preference if patient unable to tolerate paclitaxel due to infusion reaction). The NAC regimen will be determined by the treating physician prior to starting on this trial. Receives: Drug: Eftilagimod Alfa (Efti); Drug: Docetaxel-cyclophosphamide (TC) intravenous (i.v); Drug: Dose dense Adriamycin-cyclophosphamide (AC) i.v

What is being measured

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

To determine pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) and Efti treatment
The number of pathological complete responses determined in surgical pathology report. The primary endpoint is pCR to NAC + efti. Simon's 2-stage design will be used. The null hypothesis that the true pCR rate is 0.08 (8%) will be tested against a one-sided alternative. In the first stage, 30 patients will be accrued. If there are 2 or fewer responses in these 30 patients, the study will be stopped. Otherwise, 20 additional patients will be accrued for a total of 50. The null hypothesis will be rejected if 8 or more responses are observed in 50 patients. This design yields a type I error rate of 0.0426 and power of 0.80 when the true pCR rate is 0.20 (20%).
Measured: From enrollment to the end of the study (5 years)

Secondary outcomes (2)

To determine clinical response to Efti + NAC.
Clinical response is determined by clinical/imaging measurements of the tumor performed at baseline, during and end of treatment phase.
Complete clinical response is defined as no measurable disease per imaging and by exam. Partial response is defined as > 15% decrease in baseline measurements by clinical/imaging to complete response criteria (as above) Stable disease is defined as no change in measurements by clinical/imaging +/- 15% . Progressive disease is defined as increase in clinical/imaging measurement by 15% of baseline measurements or development of a new mass/lesion. The % of patients in each response category will be reported as a descriptive measure. .
Measured: From enrollment to the end of study (5 years)
To determine change in tumor's Ki67
Compare baseline tumor's Ki67 to that in residual tumor after surgical resection. Wilcoxon signed-rank test be done to compare change in Ki67 between 2 specimens for tumors which have residual disease at time of surgery.
Measured: From enrollment to the end of study (5 years)

Timeline

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

1 Sep 2026Aug 2028

First posted5 Aug 2025
Study start1 Sep 2026 (estimated)
Primary completionAug 2028 (estimated)
Study completionAug 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by George Washington UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07102940
Sponsor's protocol ID: LAG3-IIT
Status last verified: Jun 2026
First submitted: 2 Jul 2025
Last updated: 11 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Pavani Chalasani, MD

202-741-2277

pchalasani@mfa.gwu.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Eftilagimod Alpha in Combination With Neoadjuvant Chemotherapy in Patients With Hormone Receptor Positive/HER2-neg Breast Cancer
ClinicalTrials.gov ID: NCT07102940
Acronym / sponsor ID: LAG3-IIT
Conditions: Breast Cancer, HER 2 Negative Breast Cancer, HR Positive/HER-2 Negative Breast Cancer, Stage 1-3
Keywords: breast, cancer, HER2, HR positive
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 50 participants (estimated)
Lead sponsor: George Washington UniversityUniversity, hospital or other
Collaborators: Immutep S.A.S.
Study start: 1 Sep 2026 (estimated)
Primary completion: Aug 2028 (estimated)
Study completion: Aug 2028 (estimated)
First posted: 5 Aug 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Efti + NAC Regimens	Experimental	Drug: Eftilagimod Alfa (Efti), Drug: Docetaxel-cyclophosphamide (TC) intravenous (i.v), Drug: Dose dense Adriamycin-cyclophosphamide (AC) i.vEftilagimod Alfa (Efti) will be administered subcutaneously at a dose of 30 mg beginning of week 1 of the trial for a total of 3 doses (week 1, 2 and 3). After 3 weeks, efti will be administered starting with week 4, every 2 weeks and combined with either TC or AC. NAC regimens: * Docetaxel-cyclophosphamide (TC) intravenous (i.v) every 3 weeks (q3w) x 4, or * Dose dense Adriamycin-cyclophosphamide (AC) i.v q2w x 4 followed by weekly paclitaxel IV X12 weeks (alternatively weekly nab-paclitaxel can be used per physician's preference if patient unable to tolerate paclitaxel due to infusion reaction). The NAC regimen will be determined by the treating physician prior to starting on this trial.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Eftilagimod Alfa (Efti)Eftilagimod Alfa (Efti) will be administered subcutaneously at a dose of 30 mg beginning of week 1 of the trial for a total of 3 doses (week 1, 2 and 3). After 3 weeks, efti will be administered starting with week 4, every 2 weeks and combined with either TC or AC	Drug	Efti + NAC Regimens
Docetaxel-cyclophosphamide (TC) intravenous (i.v)TC will be administered at docetaxel 75mg/m2 IV and cyclophosphamide 600mg/m2 IV every 3 weeks for a total of 4 administrations starting on week 4 of the trial (weeks 4, 7,10, and 13). Docetaxel is administered over 60min (dilute in 250 mL NS or D5W to a final concentration of 0.3 to 0.74 mg/mL and administer over 60 minutes). Cyclophosphamide is administered over 30-60min (dilute in 250 to 500 mL NS or D5W and administer over 30 to 60 minutes after docetaxel). G-CSF support for TC is per institutional SOC guidelines. Efti is to be given always ≥ 30 minutes after TC is finished if both regimens are administered the same day.	Drug	Efti + NAC Regimens
Dose dense Adriamycin-cyclophosphamide (AC) i.vAC will be administered at doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 IV every 2 weeks for a total of 4 administrations starting week 4 of the trial (weeks 4, 6, 8 and 10): Doxorubicin is administered over 5 min (Dilute with NS to a final concentration of 2 mg/mL and administered as an IV bolus over three to five minutes into a free flowing IV infusion of NS or D5W). Cyclophosphamide is administered over 30-60min (Dilute in 250 to 500 mL NS or D5W and administer over 30 to 60 minutes). G-CSF support is per SOC/institutional guidelines. Paclitaxel is given weekly for a period of 12 weeks (weeks 12 to 23) at 80mg/m2 (Dilute with 250 to 500 mL NS or D5W (final concentration of 0.3 to 1.2 mg/mL) and administered per institutional guidelines). Alternatively nab-paclitaxel weekly can be used (if paclitaxel cannot be used due to allergic reaction). Efti is to be given always ≥ 30 minutes after AC or paclitaxel is finished if both regimens are administered the same day.	Drug	Efti + NAC Regimens

Primary outcome

To determine pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) and Efti treatment
Time frame: From enrollment to the end of the study (5 years)
The number of pathological complete responses determined in surgical pathology report. The primary endpoint is pCR to NAC + efti. Simon's 2-stage design will be used. The null hypothesis that the true pCR rate is 0.08 (8%) will be tested against a one-sided alternative. In the first stage, 30 patients will be accrued. If there are 2 or fewer responses in these 30 patients, the study will be stopped. Otherwise, 20 additional patients will be accrued for a total of 50. The null hypothesis will be rejected if 8 or more responses are observed in 50 patients. This design yields a type I error rate of 0.0426 and power of 0.80 when the true pCR rate is 0.20 (20%).

2 secondary outcomes

To determine clinical response to Efti + NAC.
Time frame: From enrollment to the end of study (5 years)
To determine change in tumor's Ki67
Time frame: From enrollment to the end of study (5 years)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
Individual participant dataSharing planned: No

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Pavani Chalasani, MD contact

202-741-2277

pchalasani@mfa.gwu.edu

Richard Lush, PhD contact

rmlush3@gwu.edu

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 13 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: opening soon, as of the sponsor's last update on 11 Jun 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Pavani Chalasani, MD (202-741-2277, pchalasani@mfa.gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) and Efti treatment (time frame: From enrollment to the end of the study (5 years)). 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 NCT07102940.

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 11 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.