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Estrogen for Breast Cancer (PRESTO Trial)

Phase 2
Waitlist Available
Led By Judith Hugh, MD
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female gender
ECOG Performance status of 0 of 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

PRESTO Trial Summary

This trial will help to figure out if a two-week treatment of estrogen can decrease the rate of growth for a certain type of breast cancer.

Who is the study for?
This trial is for post-menopausal women over 5 years with ER+ breast cancer that hasn't spread, no prior hormone therapy, and can take pills. They must have good physical function and organ health but cannot be on certain drugs or have a history of blood clots or heart issues.Check my eligibility
What is being tested?
The study tests if estrogen at pre-menopausal levels given for 7-14 days before surgery can slow the growth of some ER+ breast cancers by comparing tumor growth rates in removed tissue.See study design
What are the potential side effects?
Potential side effects include reactions to estradiol such as increased risk of blood clots, stroke, changes in mood or libido, nausea, headaches, and possible impact on cholesterol levels.

PRESTO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am female.
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I am fully active or able to carry out light work.
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My breast cancer is not HER2 positive.
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My cancer is not considered highly aggressive.
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I have never taken hormone replacement therapy.
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I have been post-menopausal for more than 5 years.
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My biopsy sample is large enough for all needed tests.
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My breast cancer is estrogen receptor positive.

PRESTO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To assess changes in breast cancer proliferation after a 7-14 day trial of estradiol in newly diagnosed estrogen receptor positive post-menopausal breast cancer patients prior to surgery.
Secondary outcome measures
Analysis of recurrence/survival data based on initial Ki67 response to 7-14 day trial of estradiol.
Exploratory analysis of biologic correlates with comparison to available genotyping tests

Side effects data

From 2018 Phase 4 trial • 64 Patients • NCT02255175
18%
Breast Tenderness
15%
Cramps
15%
Itchiness at patch site
12%
Headaches
9%
Nausea
6%
Acne
6%
Lower Back Pain
6%
Hot Flashes
6%
Menstrual Bleeding
6%
Bloating
3%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Perimenopausal Women, Depressed
Perimenopausal Women, Non-depressed

PRESTO Trial Design

1Treatment groups
Experimental Treatment
Group I: Estradiol treatmentExperimental Treatment1 Intervention
Estradiol 6 mg daily for 7-14 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Estradiol
FDA approved

Find a Location

Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,193 Total Patients Enrolled
13 Trials studying Breast Cancer
1,337 Patients Enrolled for Breast Cancer
Judith Hugh, MDPrincipal InvestigatorUniversity of Alberta

Media Library

Breast Cancer Research Study Groups: Estradiol treatment
Estradiol 2023 Treatment Timeline for Medical Study. Trial Name: NCT02238808 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration approved Estradiol for clinical use?

"The safety of estradiol was estimated at a score of 2, as it has only been tested in Phase 2 trials so far and there is limited data backing its efficacy."

Answered by AI

Is there availability for participants to join this research program?

"This study is temporarily not taking on additional participants. It was initially posted in August of 2015, and its last update was February 4th 2019. For those looking for alternative trials, there are 2287 investigations recruiting individuals with malignant neoplasms and 50 clinical studies enrolling patients utilizing Estradiol."

Answered by AI

What medical conditions do practitioners usually prescribe Estradiol to treat?

"Estradiol is a viable solution for individuals who have not had their menstrual period in the previous 6 months, display signs of hypoestrogenism, and experience vasomotor symptoms commonly linked to menopause."

Answered by AI

How many candidates are being enlisted for this experiment?

"Sadly, recruitment for this trial ended in February 2019. Its initial post date was August 1st 2015. If you're on the lookout for other studies, there are 2287 active trials recruiting patients with malignant neoplasms and 50 clinical studies seeking participants to test Estradiol's efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers
2015. "A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02238808.
~2 spots leftby Apr 2025
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