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

NCT ID: NCT02057029

Last Updated: 2016-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-06-30

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

BCI Assay Results

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.

Group Type: OTHER

BCI Assay Results

Intervention Type: BEHAVIORAL

The nature of the intervention is to utilize the BCI results in the decision making process for ER-positive breast cancer patients and their physicians.

Interventions

BCI Assay Results

The nature of the intervention is to utilize the BCI results in the decision making process for ER-positive breast cancer patients and their physicians.

Intervention Type: BEHAVIORAL

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 ≥ 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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tara Sanft, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University

New Haven, Connecticut, United States

Countries

United States

References

Sanft T, Aktas B, Schroeder B, Bossuyt V, DiGiovanna M, Abu-Khalaf M, Chung G, Silber A, Hofstatter E, Mougalian S, Epstein L, Hatzis C, Schnabel C, Pusztai L. Prospective 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. Breast Cancer Res Treat. 2015 Dec;154(3):533-41. doi: 10.1007/s10549-015-3631-9. Epub 2015 Nov 14.

Reference Type: DERIVED

PMID: 26578401 (View on PubMed)

Other Identifiers

HIC#: 1309012695

Identifier Type: -

Identifier Source: org_study_id