A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers (PRESTO)
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|ClinicalTrials.gov Identifier: NCT02238808|
Recruitment Status : Recruiting
First Posted : September 12, 2014
Last Update Posted : January 5, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Estrogen Receptor Positive Breast Cancer||Drug: Estradiol||Phase 2|
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 showed that estrogen treated hysterectomized women with no prior history of breast cancer had a significant and persistent decrease in breast cancer incidence when compared to placebo treated participants. This implies that some ER+ breast cancers are in fact growth inhibited by estrogens and are not growth promoted.
The hypothesis of this study is that some ER+ breast cancers (luminal A) are actually sensitive (growth inhibited) by estrogen.
- 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.
- Exploratory analysis of biologic correlates with comparison to available genotyping tests.
This is an open-label single group assignment pilot study for safety/efficacy and exploratory biologic correlates
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PRe-operative ESTradiOl Window of Opportunity Study in Post-Menopausal Women With Newly Diagnosed ER Positive Breast Cancer|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||January 2027|
Experimental: Estradiol treatment
Estradiol 6 mg daily for 7-14 days
Eligible participants will take 2 mg Estradiol 3 times daily for 7-14 days pre-surgery.
Other Name: estrogen
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02238808
|Contact: Judith Hugh, MDemail@example.com|
|Contact: John Mackey, MDfirstname.lastname@example.org|
|Cross Cancer Institute||Recruiting|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Contact: Judith Hugh, MD 780-407-2872 email@example.com|
|Principal Investigator:||Judith Hugh, MD||University of Alberta|