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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