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Hormone Therapy

Therapeutic Estradiol for Breast Cancer

Phase 2

Waitlist Available

Led By Matthew P. Goetz, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women must be postmenopausal

Presence of moderate or strong nuclear ERbeta staining in > 25% of cells in specimen submitted during Pre-Screening Step

Must not have

History of coagulopathy

Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled symptomatic cardiac arrhythmia, uncontrolled hypertension (defined as blood pressure > 160/90)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well estradiol works in treating patients with a certain type of breast cancer that has spread.

Who is the study for?

This trial is for postmenopausal women with a specific breast cancer type that's spread within the body or to nearby areas. Participants must have ER beta positive, triple negative tumors and be in good general health (ECOG status 0 or 1). They should not have had more than three prior chemo treatments for metastatic breast cancer and must agree to undergo necessary biopsies.

What is being tested?

The study tests how effective estradiol, a form of estrogen, is on patients whose tumor cells overexpress ER beta but lack other hormone receptors. The goal is to see if estradiol can shrink these specific types of tumor cells. Various imaging techniques like CT scans will monitor the results.

What are the potential side effects?

Potential side effects from therapeutic estradiol may include an increased risk of blood clots, changes in mood or sex drive, nausea, headaches, high blood pressure, and vaginal irritation or discharge. Each person might experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have gone through menopause.

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My cancer cells show a certain level of ERbeta protein.

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I agree to provide a biopsy sample for testing.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My tumor is negative for both ER and HER2.

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I have had 3 or fewer chemotherapy treatments for my metastatic breast cancer.

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I can take pills by mouth.

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My breast cancer is not driven by estrogen or HER2.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of blood clotting disorders.

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I do not have any serious ongoing illnesses, including heart problems or uncontrolled high blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical benefit rate

Secondary study objectives

Changes in phospho-ERbeta, cystatins 1, 2, 4 and 5, phospho-Smad2/3 and Ki-67

Incidence of adverse events

Overall survival distribution

+2 more

Other study objectives

Changes in serum cystatin levels in response to treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (estradiol)Experimental Treatment5 Interventions

Patients receive estradiol PO TID for days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a tissue biopsy at the end of cycle 1, collection of blood samples on C1D1, at the end of cycle 1, and at the end of treatment. In addition, patients undergo CT, MRI, or PET scans at baseline, at the end of cycles 2, 4, and 6, and then every 8 weeks until disease progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1150

Positron Emission Tomography

2011

Completed Phase 2

~2200