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

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

Conditions

Metastatic Breast Cancer

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Metastatic Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Lebanon

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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%.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Dartmouth-Hitchcock Medical Center,

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

Study Record Dates

2027-05