Metastatic Breast Cancer Clinical Trial
— ESTHEROfficial title:
Phase II Study of Estradiol Therapy to Target ER-Mutant and ER-Wild-Type ER+ Metastatic or Advanced Breast Cancer
NCT number | NCT05716516 |
Other study ID # | 22SCH740 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | May 4, 2023 |
Est. completion date | May 2027 |
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
Status | Recruiting |
Enrollment | 36 |
Est. completion date | May 2027 |
Est. primary completion date | May 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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%. |
Country | Name | City | State |
---|---|---|---|
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Benefit Rate | The clinical benefit rate (complete responses + partial responses + stable disease at 24 weeks) will be ascertained and compared between subjects treated with 17b-estradiol harboring amplified/mutant ESR1 and wild-type ESR1. | 12 months | |
Secondary | Objective response rate | The objective response rate (complete + partial responses) to the first 8 weeks of treatment with 17b-estradiol will be ascertained and compared between subjects harboring amplified/mutant ESR1 and wild-type ESR1. | 8 weeks | |
Secondary | Progression-free survival | Progression-free survival with 17b-estradiol treatment will be ascertained and compared between subjects harboring amplified/mutant ESR1 and wild-type ESR1. | 12 months | |
Secondary | Tumor Metabolic response | Tumor metabolic response will be defined as the best response at any time point per PERCIST. The metabolic response rate (complete + partial metabolic response) will be ascertained and compared between subjects treated with 17b-estradiol harboring amplified/mutant ESR1 and wild-type ESR1. | 12 months | |
Secondary | Adverse event profiles | The number of participants with treatment-related adverse events as assessed by CTCAE v5.0 will be collected | 12 months |
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