STUDY02001740;22SCH740: Estradiol For ER+ Advanced Breast Cancer (ESTHER)

Recruiting now · Phase 2

Conditions studied: Metastatic Breast Cancer

In brief

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

Key facts

Study ID

NCT05716516

Run by

Dartmouth-Hitchcock Medical Center

People needed

36

Starts

2023-05-04

Expected to finish

2027-05-01

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)

Full record on ClinicalTrials.gov

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