STUDY02001740;22SCH740: Estradiol For ER+ Advanced Breast Cancer (ESTHER) (NCT05716516) | Clinical Trial Compass
RecruitingPhase 2
STUDY02001740;22SCH740: Estradiol For ER+ Advanced Breast Cancer (ESTHER)
United States36 participantsStarted 2023-05-04
Plain-language summary
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 participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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%.