A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers

• Register: ClinicalTrials.gov
• Last refreshed on: 13 February 2023
• Main ID: NCT02238808
• Date of registration: 10/09/2014
• Prospective Registration: Yes
• Primary sponsor: AHS Cancer Control Alberta
• Public title: A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers PRESTO
• Scientific title: PRe-operative ESTradiOl Window of Opportunity Study in Post-Menopausal Women With Newly Diagnosed ER Positive Breast Cancer
• Date of first enrolment: August 2015
• Target sample size: 19
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02238808
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Judith Hugh, MD
• Affiliation: University of Alberta

Key inclusion & exclusion criteria

Inclusion Criteria:

- Female gender

- Estrogen receptor positive (ER+) breast cancer

- HER2 negative breast cancer

- Post-menopausal by greater than 5 years

- No previous hormonal replacement therapy

- Low to intermediate histologic grade

- ECOG Performance status of 0 of 1

- Adequate hematological, renal and hepatic function is required

- Ability to take oral medication

- Patient must have adequate tissue for diagnosis, biomarkers and Ki67 assays

Exclusion Criteria:

- Pre-menopausal women

- Locally advanced or metastatic breast cancer

- Current, previous or planning for pre-operative treatment with chemotherapy, hormone
therapy including corticosteroids, radiation therapy for malignancy or other condition

- Known hypersensitivity or intolerance to estradiol

- Ischemic changes on baseline electrocardiogram

- Symptomatic but untreated cholelithiasis

- History of deep vein thrombosis, pulmonary embolism, stroke, acute myocardial
infarction, congestive cardiac failure, untreated hypertension or known inherited
hypercoagulable disorder

- Undiagnosed abnormal vaginal bleeding or prior history of endometrial cancer

- Untreated metabolic disturbances (glucose > 15.0 mmol/L and triglycerides > 400 mg/dL)

- Current treatment with drugs known to be moderate or strong inhibitors of inducers of
isoenzyme CYP3A4

- The time between study enrolment and definitive breast surgery is not sufficient for
administration of at least 7 days of estradiol



Age minimum: 55 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Estrogen Receptor Positive Breast Cancer

Intervention(s)

Drug: Estradiol

Primary Outcome(s)

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. [Time Frame: end of 7-14 day treatment with estradiol]

Secondary Outcome(s)

Exploratory analysis of biologic correlates with comparison to available genotyping tests [Time Frame: end of 7-14 day treatment with estradiol]

Analysis of recurrence/survival data based on initial Ki67 response to 7-14 day trial of estradiol. [Time Frame: 10 years]

Secondary ID(s)

EER001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors