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

Yale University

Status: Completed

Conditions: Breast Cancer; Early Stage Estrogen Receptor (ER) Positive Breast Cancer

Treatments: Behavioral: BCI Assay Results

Study type: Interventional

Funder types: Other

Identifiers

NCT02057029

HIC#: 1309012695

Details and patient eligibility

About

Investigators will examine the impact of the Breast Cancer Index (BCI) result on patients' anxiety / fear of recurrence and satisfaction with decisions regarding endocrine therapy.

Full description

The investigators' objective is to assess patient decision-making, anxiety and patient satisfaction with recommendations made by an oncologist before and after the BCI test results are known. In addition, a chart review will be performed annually for five years to assess disease status and medications. Specifically, if extended endocrine therapy was recommended the chart review will record if participants are taking the medication and, if not, why the treatment was discontinued.

Enrollment: 96 patients

Sex: Female

Volunteers: No Healthy Volunteers

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 ≥ 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

96 participants in 1 patient group

BCI Assay Results

Other group

Description:

The Breast Cancer Index (BCI) is a novel gene expression-based prognostic predictor for ER positive cancers and is provided through a CLIA certified commercial laboratory. It is an RT-PCR assay that can be performed on formalin fixed paraffin embedded sections of archived tissues. Participants will work in concert with a physician to determine future treatment options based on BCI results.

Treatment:

Behavioral: BCI Assay Results