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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date November 2023
Source Dartmouth-Hitchcock Medical Center
Contact Research Nurse
Phone 1-800-639-6918
Email Cancer.Research.Nurse@dartmouth.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

Patients with endocrine-resistant breast cancer are eligible. Treatment Phase: Patients will be treated with 17b-estradiol until disease progression. At this point, the patient will end protocol therapy. Clinical benefit, progression-free survival, objective response, tumor metabolic response, and toxicity will be determined. Observational Phase (optional): After disease progression on 17b-estradiol, patients will be treated at their oncologist's discretion. Clinical benefit, progression-free survival, and objective response will be measured during this line of treatment of physician's choice until another instance of disease progression. In consented subjects who undergo a clinically indicated tumor biopsy of recurrent or metastatic disease prior to the start of 17b-estradiol treatment, when feasible, acquisition of additional tumor tissue is requested for research purposes. Optional: patients will be asked to provide tumor tissue via a research biopsy on Day 3-4 of 17b-estradiol treatment. Archived tumor tissue and clinical-grade tumor and plasma DNA/RNA sequencing results will be used for research purposes. Blood samples will be obtained at baseline, on Day 3-4 of 17b-estradiol therapy (optional), and upon disease progression on 17b-estradiol. Plasma and buffy coat will be extracted and frozen. Tumor tissue and plasma specimens will be analyzed to identify molecular biomarkers predictive of sensitivity/resistance to 17b-estradiol therapy


Recruitment information / eligibility

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%.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Estradiol
Estradiol is a therapeutic option for the treatment of advanced ER+ breast cancer

Locations

Country Name City State
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire

Sponsors (1)

Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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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