Elacestrant in Advanced Triple Positive Breast Cancer

NCT07612215 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 25-00779
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study to assess the safety and efficacy of elacestrant, a selective estrogen receptor degrader (SERD) and dual biologic therapy, trastuzumab and pertuzumab, in patients with triple-positive breast cancer with and without an ESR1 mutation.

Conditions

ER Positive, HER2 Positive Breast Cancer

Keywords

breast cancer; ESR1 mutation; ESR1; triple positive breast cancer

Outcome Measures

Primary Outcomes (1)

• Median progression-free survival

  Progression-free survival will be measured as the time from the date of first dose to the date of first radiological documentation of disease progression or death, whichever occurs first.

  From the date of first dose to the date of first radiological documentation of disease progression or death, whichever occurs first (up to 2 years)

Secondary Outcomes (4)

• Objective response rate (ORR)

  End of treatment (up to 2 years)

• Duration of response (DoR)

  Time from the date of first documented CR/PR until the first radiological documentation of disease progression or death, whichever comes first (up to 2 years)

• Change in 36-Item Short Form (SF-36) Health Survey

  Baseline, End of treatment (up to 2 years)

• Overall survival (OS)

  From the date of the first dose to the date of death from any cause (up to 2 years)

Study Arms (2)

Estrogen Receptor 1 (ESR1) wild-type (WT)

EXPERIMENTAL

Trastuzumab and pertuzumab and Elacestrant will be administered until disease progression, unacceptable toxicity or as per PI's decision

Drug: Elacestrant; Drug: Trastuzumab; Drug: Pertuzumab

ESR1 Mutated

EXPERIMENTAL

Trastuzumab and pertuzumab and Elacestrant will be administered until disease progression, unacceptable toxicity or as per PI's decision

Drug: Elacestrant; Drug: Trastuzumab; Drug: Pertuzumab

Interventions

Elacestrant DRUG

Elacestrant will be administered orally once daily at a dose of 345 mg daily.

ESR1 Mutated; Estrogen Receptor 1 (ESR1) wild-type (WT)

Trastuzumab DRUG

Initial dose of trastuzumab is 8 mg/kg administered as a 90-minute intravenous infusion, followed every 3 weeks thereafter by a dose of 6 mg/kg administered as an intravenous infusion over 30 to 90 minutes.

ESR1 Mutated; Estrogen Receptor 1 (ESR1) wild-type (WT)

Pertuzumab DRUG

The initial dose of PERJETA is 840 mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by a dose of 420 mg administered as an intravenous infusion over 30 to 60 minutes.

ESR1 Mutated; Estrogen Receptor 1 (ESR1) wild-type (WT)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 18 years or older.
• Should be able to provide the informed consent.
• Histologically confirmed diagnosis of triple-positive breast cancer (ER+, PR+, HER2+). In the study, ER status will be considered positive if ≥10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry, with PR\>1%. Patients may be considered to be enrolled on study with prior approval of study PI if ER \>10% and without PGR positivity HER2 status will be considered positive with the score of 3+ with immunohistochemistry staining or 2+ by immunohistochemistry and FISH -amplified as per ASCO CAP guidelines (2023)"
• Disease progression on or after at least one line of NCCN recommended prior therapy
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Patient has adequate organ function, as defined by the following laboratory values:
• Hematologic Value:
• Hemoglobin ≥9.0 g/dL, without transfusion or growth factors within 1 week
• Neutrophils ≥1.5×103/μL or ≥1.0×103/μL for participants with benign ethnic neutropenia
• Platelets ≥100×103/μL
• Patient must have a baseline LVEF ≥50 % or ≥ institutional LLN within 28 days prior to the study treatment.
• Sex and Contraceptive/Barrier Requirements
• While on study treatment a participant must not breastfeed or be pregnant
• Have a negative highly sensitive (eg, beta-human chorionic gonadotropin \[β-hCG\]) pregnancy test at screening and agree to further pregnancy tests per the protocol.
• Practice at least 1 highly effective method of contraception; if oral contraceptives are used, a barrier method of contraception must also be used.

You may not qualify if:

• Prior treatment with a SERD.
• Prior treatment with more than two lines of chemotherapy for metastatic disease, including antibody drug conjugates.
• Untreated and/or active CNS metastases.
• History of other malignancies within the past 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix).
• Inability to take oral medications, refractory or chronic nausea, gastrointestinal conditions (including significant gastric or bowel resection), history of malabsorption syndrome, or any other uncontrolled gastrointestinal condition that impact the absorption of the study drug
• Known intolerance to elacestrant or any of its excipients
• Uncontrolled active infection or intercurrent illness.
• Patients with known HBV and/or HCV infection must have undetectable viral load during screening (See Appendix B).
• Patients known to be HIV+ are allowed if they have undetectable viral load at baseline.
• Patients who are on any of the prohibited medications listed in sections 7.6 and 7.4.
• Male participants will not be included because Male breast cancer is rare and may differ biologically and hormonally, which would introduce heterogeneity difficult to address in a small, single arm phase II trial.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

elacestrant; Trastuzumab; pertuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Douglas K Marks, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adriana Borges-Uba

CONTACT

646-754-7147; Adriana.borges-uba@nyulangone.org

Ethel Yepes

CONTACT

212-263-4402; Ethel.yepes@nyulangone.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 28, 2026
• Study Start: May 13, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2030
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Douglas.Marks@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.

Locations

US (1)