No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
36 (estimated)
Sponsor
Dartmouth-Hitchcock Medical Center · Other
Who this trial is looking for
This trial is looking for post-menopausal women with ER+ breast cancer that has spread or cannot be treated with cure. Participants will be receiving treatment with 17b-estradiol and must have had prior hormone therapy.
Are You a Good Fit for This Trial?
Rules you outCNS disease
You may be able to join if
I am a post-menopausal woman.
I have been diagnosed with ER+ breast cancer.
I have metastatic or locoregional breast cancer that cannot be cured.
I have received at least one prior hormone-based therapy.
You may not be able to join if
I am currently receiving any other cancer treatments, except some exceptions.
I have had any cancer treatment in the last 3 weeks.
I have known brain disease that is not stable for at least 3 months.
I have a history of deep venous thrombosis.
I have a history of pulmonary embolism.
I have had a stroke.
I have had a heart attack.
I have heart failure.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 Locations
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City
State
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Status
Eligibility 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 ad…
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%.
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