Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05716516 | RECRUITING | Metastatic Breast Cancer

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

Dartmouth-Hitchcock Medical Center

Information provided by (Responsible Party):

Mary D Chamberlin

Brief 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

Condition or disease

Metastatic Breast Cancer

Intervention/treatment

Estradiol

Phase

PHASE2

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 36 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Phase II Study of Estradiol Therapy to Target ER-Mutant and ER-Wild-Type ER+ Metastatic or Advanced Breast Cancer
Actual Study Start Date : 2023-05-04
Estimated Primary Completion Date : 2026-05
Estimated Study Completion Date : 2027-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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%.
STUDY02001740;22SCH740: Estradiol For ER+ Advanced Breast Cancer (ESTHER)

Location Details

NCT05716516

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New Hampshire

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756