STUDY02001740;22SCH740: Estradiol For ER+ Advanced Breast Cancer (ESTHER)

Trial Title: STUDY02001740;22SCH740: Estradiol For ER+ Advanced Breast Cancer (ESTHER)

NCT ID: NCT05716516

Condition: Metastatic Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Estradiol

Conditions: Keywords:
Metastatic
Locally advanced
Estradiol therapy
Estrogen therapy

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Estradiol
Description: Estradiol is a therapeutic option for the treatment of advanced ER+ breast cancer
Arm group label: Treatment Arm

Other name: Estrace

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

Detailed 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

Criteria for eligibility:
Criteria:
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%.

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Dartmouth-Hitchcock Medical Center

Address:
City: Lebanon
Zip: 03756
Country: United States

Status: Recruiting

Start date: May 4, 2023

Completion date: May 2027

Lead sponsor:
Agency: Dartmouth-Hitchcock Medical Center
Agency class: Other

Source: Dartmouth-Hitchcock Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05716516