RECRUITING

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

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Conditions

Metastatic Breast CancerMetastaticLocally advancedEstradiol therapyEstrogen therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Phase II Study of Estradiol Therapy to Target ER-Mutant and ER-Wild-Type ER+ Metastatic or Advanced Breast Cancer

Quick Facts

Study Start:2023-05-04
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05716516

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Post-menopausal women with ER+ breast cancer.
  2. * Metastatic or locoregional recurrence not amenable to treatment with curative
  3. * intent.
  4. * Received ≥1 prior line of endocrine-based therapy (e.g., including tamoxifen, aromatase inhibitors, fulvestrant, or combinations) in the advanced/metastatic setting
  1. * During the study Treatment Phase with 17b-estradiol, no concurrent anti-cancer therapies are allowed with the following exceptions:
  2. * Exception: Trastuzumab is allowed for the treatment of subjects with a history of HER2+ disease, and will be used at the physician's discretion.
  3. * Exception: Anti-resorptive bone therapies (e.g., bisphosphonates, denosumab) are permitted.
  4. * Any investigational cancer therapy in the last 3 weeks.
  5. * Known CNS disease, unless clinically stable for ≥ 3 months.
  6. * History of any of the following:
  7. * Deep venous thrombosis.
  8. * Pulmonary embolism.
  9. * Stroke.
  10. * Acute myocardial infarction.
  11. * Congestive heart failure.
  12. * Previous malignancy not treated with curative intent, or with an estimated recurrence risk ≥30%.

Contacts and Locations

Study Contact

Research Nurse
CONTACT
1-800-639-6918
Cancer.Research.Nurse@dartmouth.edu

Principal Investigator

Mary Chamberlin, MD
PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center

Study Locations (Sites)

Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States

Collaborators and Investigators

Sponsor: Dartmouth-Hitchcock Medical Center

  • Mary Chamberlin, MD, PRINCIPAL_INVESTIGATOR, Dartmouth-Hitchcock Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-04
Study Completion Date2027-05

Study Record Updates

Study Start Date2023-05-04
Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

  • Metastatic
  • Locally advanced
  • Estradiol therapy
  • Estrogen therapy

Additional Relevant MeSH Terms

  • Metastatic Breast Cancer