NCT05716516RecruitingPhase 2
STUDY02001740;22SCH740: Estradiol For ER+ Advanced Breast Cancer (ESTHER)
Phase II Study of Estradiol Therapy to Target ER-Mutant and ER-Wild-Type ER+ Metastatic or Advanced Breast Cancer
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
Determine whether subjects harboring ESR1-mutant/amplified breast cancer have a higher rate of clinical benefit from 17b-estradiol therapy than subjects with ESR1-wild-type breast cancer
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 28 Jan 2023
- Start date
- 4 May 2023
- Primary completion date
- May 2027
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05716516
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 36
- From 4 May 2023 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- During the study Treatment Phase with 17b-estradiol, no concurrent anti-cancer therapies are allowed with the following exceptions:
- Exception: Trastuzumab is allowed for the treatment of subjects with a history of HER2+ disease, and will be used at the physician's discretion.
- Exception: Anti-resorptive bone therapies (e.g., bisphosphonates, denosumab) are permitted.
Other illness
- Any investigational cancer therapy in the last 3 weeks.
- Known CNS disease, unless clinically stable for ≥ 3 months.
- History of any of the following:
- Deep venous thrombosis.
- Pulmonary embolism.
- Stroke.
- Acute myocardial infarction.
- Congestive heart failure.
- Previous malignancy not treated with curative intent, or with an estimated recurrence risk ≥30%.
Who the study is looking for
- Post-menopausal women with ER+ breast cancer.
- Metastatic or locoregional recurrence not amenable to treatment with curative
- intent.
- Received ≥1 prior line of endocrine-based therapy (e.g., including tamoxifen, aromatase inhibitors, fulvestrant, or combinations) in the advanced/metastatic setting
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.