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Assessment of the Decision-making Impact of the Breast Cancer Index in Recommending Extended Adjuvant Endocrine Therapy for Patients with Early Stage ER-positive Breast Cancer

Conditions

Trial Phase

Trial Purpose and Description

Trial Purpose

Five independent randomized clinical trials confirmed the benefit of extended adjuvant endocrine therapy (for a total duration of 10 years) in patients who have completed 5 years of endocrine therapy for early stage ER-positive breast cancer. However, the absolute number of recurrences is low, and the side effects of long duration of endocrine therapy can be significant. In order to decide which women are at highest risk for recurrence after 5 years, and therefore should be treated with extended adjuvant therapy, additional information may be helpful. Recently a diagnostic test, the Breast Cancer Index (BCI), has become commercially available to estimate the risk of late recurrence and potential benefit from extended endocrine therapy. This study is designed to examine the decision a patient and her doctor makes about extended (beyond 5 years) endocrine therapy, both before and after the results of the BCI test result is known.


Participation Guidelines

Age:
Gender:
Female

Eligibility Criteria

Inclusion Criteria

Each patient must meet all of the following criteria in order to be considered for enrollment:

Histologically confirmed ER positive, stage I-III breast cancer who have been treated with curative intent and completed at least four years of adjuvant endocrine therapy.
Life expectancy, greater than or equal to 5 years.
Must be able to provide informed consent.
Willing to consider continuation of endocrine therapy beyond 5 years.


Exclusion Criteria

A patient must not be enrolled if any contraindication exists for extended adjuvant endocrine therapy as identified by the treating oncologist.

Sponsor:
BioTheranostics Inc.
Dates:
02/04/2014
Last Updated:
Study HIC#:
1309012695