STUDY02001740;22SCH740: Estradiol For ER+ Advanced Breast Cancer (ESTHER)
Recruiting · NCT05716516 · Interventional (participants receive a specific treatment) · Lead sponsor: Dartmouth-Hitchcock Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
Estradiol
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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.
- 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%.
Where it is running
1 location listed across 1 US state.
- Dartmouth-Hitchcock Medical Center - Lebanon, New Hampshire, United States