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

ConditionMetastatic Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDartmouth-Hitchcock Medical Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Estradiol

    Drug

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

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Treatment ArmOther 1 intervention

Trial outcomes

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.

Time frame
12 months

Secondary outcomes

1

Objective response rate

The objective response rate (complete + partial responses) to the first 8 weeks of treatment with 17b-estradiol will be ascertained and compared between subjects harboring amplified/mutant ESR1 and wild-type ESR1.

Time frame
8 weeks
2

Progression-free survival

Progression-free survival with 17b-estradiol treatment will be ascertained and compared between subjects harboring amplified/mutant ESR1 and wild-type ESR1.

Time frame
12 months
3

Tumor Metabolic response

Tumor metabolic response will be defined as the best response at any time point per PERCIST. The metabolic response rate (complete + partial metabolic response) will be ascertained and compared between subjects treated with 17b-estradiol harboring amplified/mutant ESR1 and wild-type ESR1.

Time frame
12 months
4

Adverse event profiles

The number of participants with treatment-related adverse events as assessed by CTCAE v5.0 will be collected

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dartmouth-Hitchcock Medical Center

Lead sponsor

Source ClinicalTrials.gov
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