Multiplex Testing for Breast Cancer Susceptibility: A Pilot Study of Subject Preferences for Information and Responses After Testing

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Pre-test Assessment; Behavioral: Pre test Counseling; Other: Blood draw; Behavioral: Follow-up assessments (6 and 12 months); Behavioral: Post-test counseling, and post-test assessment

Study type: Observational

Funder types: Other

Identifiers

NCT01992471

13-215

Details and patient eligibility

About

The purpose of this study is to find out what kinds of information people would like to receive from a new kind of genetic testing, and how they respond to this new kind of testing.

Enrollment: 197 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Female age 18 or older
• Personal history of breast cancer AND one of the following:
• Invasive breast cancer or DCIS diagnosed at or before age 45 Invasive breast cancer diagnosed at/before age 50 with one or more of the following:
• Limited family history (Fewer than 2 first- or second-degree female relatives in the same lineage that lived to age 45. The "limited family history" can occur on either the maternal or paternal side of the family.)
• 1 or more first-/second-degree relatives with invasive BC at/before 50
• 1 or more first-/second-degree relatives with invasive epithelial ovarian cancer (any age)
• 1 or more first- or second-degree relatives with male breast cancer
• 2 or more first- or second-degree relatives with pancreas cancer
• Invasive breast cancer diagnosed at or before age 60 with at least 2 first or second-degree relatives affected with any combination of invasive breast cancer before age 50, invasive epithelial ovarian cancer at any age, male breast cancer, or pancreas cancer.
• Full sequence BRCA1 and BRCA2 testing completed with no deleterious mutation identified.

Exclusion criteria

• Unable to provide informed consent for testing
• Unable to complete English language questionnaire

Trial design

197 participants in 1 patient group

history of breast cancer who have undergone BRCA1/2 testing

Description:

This is a single-arm observational study. Subjects with a history of breast cancer who have undergone BRCA1/2 testing and have received uninformative findings will enroll in this study, and then receive pre-test counseling for multiplex testing.

Treatment:

Other: Blood draw

Behavioral: Pre test Counseling

Behavioral: Pre-test Assessment

Behavioral: Post-test counseling, and post-test assessment

Behavioral: Follow-up assessments (6 and 12 months)