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

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by AHS Cancer Control Alberta
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT02238808
First received: September 10, 2014
Last updated: January 4, 2017
Last verified: January 2017
  Purpose

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 Intervention Phase
Estrogen Receptor Positive Breast Cancer Drug: Estradiol Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PRe-operative ESTradiOl Window of Opportunity Study in Post-Menopausal Women With Newly Diagnosed ER Positive Breast Cancer

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: August 2015
Estimated Study Completion Date: January 2027
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Estradiol treatment
Estradiol 6 mg daily for 7-14 days
Drug: Estradiol
Eligible participants will take 2 mg Estradiol 3 times daily for 7-14 days pre-surgery.
Other Name: estrogen

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 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.

Objectives:

  1. 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.
  2. 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

  Eligibility

Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02238808

Contacts
Contact: Judith Hugh, MD 780-407-2872 judith.hugh@albertahealthservices.ca
Contact: John Mackey, MD 780-432-8221 john.mackey@albertahealthservices.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Judith Hugh, MD    780-407-2872    judith.hugh@albertahealthservices.ca   
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Judith Hugh, MD University of Alberta
  More Information

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT02238808     History of Changes
Other Study ID Numbers: EER001
Study First Received: September 10, 2014
Last Updated: January 4, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by AHS Cancer Control Alberta:
ER+ breast cancer
Luminal A
Estradiol

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estradiol
Polyestradiol phosphate
Estrogens
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on June 22, 2017