RecruitingPhase 2NCT05716516
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
Sponsor
Dartmouth-Hitchcock Medical Center
Enrollment
36 participants
Start Date
May 4, 2023
Study Type
INTERVENTIONAL
Conditions
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
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria4
- 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 Criteria12
- 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%.
Interventions
DRUGEstradiol
Estradiol is a therapeutic option for the treatment of advanced ER+ breast cancer
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05716516
Related Trials
A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors
NCT06157892139 locations
Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer
NCT066493311 location
Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)
NCT059645044 locations
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
NCT0708576735 locations
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
NCT0342400545 locations