ER Positive, HER2 Positive Breast CancerPhase 1/2NCT07612215
Elacestrant in Advanced Triple Positive Breast Cancer
A Phase 1/2 study testing Elacestrant, Trastuzumab and Pertuzumab in people with ER Positive, HER2 Positive Breast Cancer, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- ER Positive, HER2 Positive Breast Cancer
- What is being tested?
- Elacestrant, Trastuzumab and Pertuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2026to May 2030
- Phase
- Phase 1/2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
- Female participants (pre- or perimenopausal) must use the appropriate highly effective, non-hormonal contraception method within 28 days of the first dose of study treatment, until 7 months after the last dose of study treatment (or longer based on companion drug). Highly effective methods of contraception are those methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include:
- intrauterine device (IUD) ii. bilateral tubal occlusion iii. vasectomized partner iv. sexual abstinence (i.e., refraining from heterosexual intercourse during the study treatment and 120 days after the last dose of study treatment).
- Unacceptable contraception methods: Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea methods are not acceptable methods of contraception. Female condom and male condom should not be used together.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: Elacestrant in Advanced Triple Positive Breast Cancer, a Phase II Evaluation (ELATE)
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
- Being tested
- Elacestrant, Trastuzumab, Pertuzumab
- Keywords
- breast cancer, ESR1 mutation, ESR1, triple positive breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElacestrantDrug
Elacestrant will be administered orally once daily at a dose of 345 mg daily.
TrastuzumabDrug
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.
PertuzumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Elacestrant; Drug: Trastuzumab; Drug: Pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Overall response rate, defined as the percentage of patients who achieve a Best Overall Response (BOR) of confirmed partial response (PR) or complete response (CR).
Measured: End of treatment (up to 2 years)
Duration of response (DoR)
Measured: 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
36-Item Short Form (SF-36) Health Survey (Version 2) The physical component summary (PCS) score, derived from the 36-Item Short Form (SF-36) Health Survey (Version 2). The range of the SF-36 PCS is between 0 and 100, where higher scores represent better physical functioning.
Measured: Baseline, End of treatment (up to 2 years)
Overall survival (OS)
Overall survival is defined as the time from the date of the first dose to the date of death from any cause.
Measured: From the date of the first dose to the date of death from any cause (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start13 May 2026
- Primary completionMay 2029 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ER Positive, HER2 Positive Breast CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas K Marks, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612215
- Sponsor's protocol ID
- 25-00779
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Douglas.Marks@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elacestrant in Advanced Triple Positive Breast Cancer, a Phase II Evaluation (ELATE)
- ClinicalTrials.gov ID
- NCT07612215
- Acronym / sponsor ID
- 25-00779
- Conditions
- ER Positive, HER2 Positive Breast Cancer
- Keywords
- breast cancer, ESR1 mutation, ESR1, triple positive breast cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 13 May 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 28 May 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estrogen Receptor 1 (ESR1) wild-type (WT) | Experimental | Drug: Elacestrant, Drug: Trastuzumab, Drug: PertuzumabTrastuzumab and pertuzumab and Elacestrant will be administered until disease progression, unacceptable toxicity or as per PI's decision |
| ESR1 Mutated | Experimental | Drug: Elacestrant, Drug: Trastuzumab, Drug: PertuzumabTrastuzumab and pertuzumab and Elacestrant will be administered until disease progression, unacceptable toxicity or as per PI's decision |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| ElacestrantElacestrant will be administered orally once daily at a dose of 345 mg daily. | Drug | ESR1 Mutated, Estrogen Receptor 1 (ESR1) wild-type (WT) |
| TrastuzumabInitial 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. | Drug | ESR1 Mutated, Estrogen Receptor 1 (ESR1) wild-type (WT) |
| PertuzumabThe 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. | Drug | ESR1 Mutated, Estrogen Receptor 1 (ESR1) wild-type (WT) |
Primary outcome
Median progression-free survival
Time frame: 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)
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.
4 secondary outcomes
Objective response rate (ORR)
Time frame: End of treatment (up to 2 years)
Duration of response (DoR)
Time frame: 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
Time frame: Baseline, End of treatment (up to 2 years)
Overall survival (OS)
Time frame: From the date of the first dose to the date of death from any cause (up to 2 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 28 May 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Douglas.Marks@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Douglas K Marks, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Elacestrant, Trastuzumab and Pertuzumab in people with ER Positive, HER2 Positive Breast Cancer, run by NYU Langone Health at 1 site in United States.
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 18 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined 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.
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 Adriana Borges-Uba (646-754-7147, Adriana.borges-uba@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median progression-free survival (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2026.