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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
Must not have
Pre-menopausal women
Symptomatic but untreated cholelithiasis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am a woman who has not gone through menopause.
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I have gallstones that cause symptoms but haven't been treated.
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I am currently taking medication that strongly affects liver enzyme CYP3A4.
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My breast cancer has spread beyond the breast and nearby lymph nodes.
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I am currently undergoing, have had, or plan to have chemotherapy, hormone therapy including corticosteroids, or radiation therapy for cancer.
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I have a history of blood clots, stroke, heart issues, untreated high blood pressure, or a genetic clotting disorder.
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I have had abnormal vaginal bleeding without a diagnosis or a history of endometrial cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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
26,812 Total Patients Enrolled
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
~2 spots leftby Dec 2025
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