Clinical Trial: NCT02238808 - My Cancer Genome

NCT02238808

Description:

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.

Related Conditions:

Breast Carcinoma

Recruiting Status:

Active, not recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT02238808

Trial Eligibility

Document

Title

Brief Title: A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers
Official Title: PRe-operative ESTradiOl Window of Opportunity Study in Post-Menopausal Women With Newly Diagnosed ER Positive Breast Cancer

Clinical Trial IDs

ORG STUDY ID: EER001
NCT ID: NCT02238808

Conditions

Estrogen Receptor Positive Breast Cancer

Interventions

Drug	Synonyms	Arms
Estradiol	estrogen	Estradiol treatment

Purpose

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

Trial Arms

Name	Type	Description	Interventions
Estradiol treatment	Experimental	Estradiol 6 mg daily for 7-14 days	Estradiol

Eligibility 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

Maximum Eligible Age:	N/A
Minimum Eligible Age:	55 Years
Eligible Gender:	Female
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	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
Safety Issue:
Description:

Secondary Outcome Measures

Measure:	Exploratory analysis of biologic correlates with comparison to available genotyping tests
Time Frame:	end of 7-14 day treatment with estradiol
Safety Issue:
Description:

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

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Active, not recruiting
Lead Sponsor:	AHS Cancer Control Alberta

Trial Keywords

ER+ breast cancer
Luminal A
Estradiol

Last Updated

February 6, 2019

Clinical Trials /

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