STUDY02001740;22SCH740: Estradiol For ER+ Advanced Breast Cancer (ESTHER)
ConditionMetastatic Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDartmouth-Hitchcock Medical Center
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Estradiol
Treatment groups
36 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov