NCT05716516

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
12mo left

Started May 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
May 2023May 2027

First Submitted

Initial submission to the registry

January 28, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

May 4, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

January 28, 2023

Last Update Submit

April 30, 2026

Conditions

Metastatic Breast Cancer

Keywords

MetastaticLocally advancedEstradiol therapyEstrogen therapy

Outcome Measures

Primary Outcomes (1)

  • Clinical Benefit Rate

    The clinical benefit rate (complete responses + partial responses + stable disease at 24 weeks) will be ascertained and compared between subjects treated with 17b-estradiol harboring amplified/mutant ESR1 and wild-type ESR1.

    12 months

Secondary Outcomes (4)

  • Objective response rate

    8 weeks

  • Progression-free survival

    12 months

  • Tumor Metabolic response

    12 months

  • Adverse event profiles

    12 months

Study Arms (1)

Treatment Arm

OTHER

Treatment Phase: Patients will be treated with 17b-estradiol until disease progression. At this point, the patient will end protocol therapy

Drug: Estradiol

Interventions

EstradiolDRUG

Estradiol is a therapeutic option for the treatment of advanced ER+ breast cancer

Also known as: Estrace
Treatment Arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Muhammad Azfal, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Nurse

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

January 28, 2023

First Posted

February 8, 2023

Study Start

May 4, 2023

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)