๐๏ธ Verified NIH Record โข Updated 2026-05-21
Elacestrant in Advanced Triple Positive Breast Cancer (NCT07612215)
๐ข Recruiting Phase1 / Phase2 ๐ Investigational Drug / Biologic Sponsor: NYU Langone Health
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (16 items) and avoid the listed exclusions (12 items).
Location: NYU Langone Health โ New York, New York
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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.
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (1 Sites)
- NYU Langone Health โ New York, New York
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.