Active — Not RecruitingPhase 2

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

Canada19 participantsStarted 2015-08

Plain-language 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 perfect way to tell these groups apart nor do the investigators know why some respond when others do not. Research findings suggest that the two types of ER+ breast cancers differ in their response to estrogen with estrogen being toxic to one type and not the other. For those tumours that find estrogen toxic, this may explain why tumours only start to grow when estrogen levels decrease after menopause. The purpose of this study is to see whether a two-week treatment of estrogen equal to pre-menopausal estrogen levels will decrease the rate at which patients' ER+ tumours grow. This will be done by comparing the growth rate in the tissue removed during standard of care surgery after patients have been treated with 7-14 days of estrogen prior to that surgery.

Who can participate

Age range

55 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: end of 7-14 day treatment with estradiol

Trial details

NCT IDNCT02238808

SponsorAHS Cancer Control Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07-30

View on ClinicalTrials.gov More Estrogen Receptor Positive Breast Cancer trials