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RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Optional: patients will be asked to provide tumor tissue via a research biopsy on Day 3-4 of 17b-estradiol treatment."
  • "Blood samples will be obtained at baseline, on Day 3-4 of 17b-estradiol therapy (optional), and upon disease progression on 17b-estradiol."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether estradiol helps people whose breast cancer has changes or extra copies of the ESR1 gene more than those without these changes. It is for women past menopause with advanced ER-positive breast cancer, which uses estrogen to grow.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women past menopause with ER-positive breast cancer.
  • Breast cancer that has spread or come back nearby and cannot be treated with the goal of a cure.
  • Have had at least one hormone-based treatment for advanced breast cancer, such as tamoxifen, an aromatase inhibitor, or fulvestrant.

Who can't join

  • Getting other cancer treatments while taking estradiol in this study. Exceptions: a doctor may allow trastuzumab for those with a history of HER2-positive cancer, and bone-protecting drugs are allowed.
  • Had an experimental cancer treatment in the last 3 weeks.
  • Known brain or spinal cord disease, unless it has been stable for at least 3 months.
  • History of a blood clot in a deep vein or in the lungs.
  • History of a stroke or heart attack.
  • History of heart failure, when the heart does not pump blood well.
  • A past cancer that was not treated with the goal of a cure, or that has an estimated 30% or higher chance of coming back.

Simplified for readability. The official criteria below are what the study team uses.

Official 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%.

Study sites (1)

NH