Status:
ACTIVE_NOT_RECRUITING
A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers
Lead Sponsor:
AHS Cancer Control Alberta
Conditions:
Estrogen Receptor Positive Breast Cancer
Eligibility:
FEMALE
55+ years
Phase:
PHASE2
Brief Summary
Some breast cancers have estrogen receptors (ER+). The investigators know that some ER+ tumours can be cured by hormone therapy alone while other ER+ breast cancers cannot. Currently, there is no perf...
Detailed Description
Breast cancer is a heterogeneous disease that includes two ER+ genetic subtypes (luminal A and luminal B) that differ in their response to treatment. Results from the Women's Health Initiative Trial ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2028
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT02238808
Start Date
August 1 2015
End Date
June 1 2028
Last Update
June 26 2025
Active Locations (1)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2