Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry (PROGECT)

University of Kansas

Status

Enrolling

Conditions

Breast Cancer

Hereditary Breast and Ovarian Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT02302742

KUMC 12614

Details and patient eligibility

About

PROGECT is a registry for patients with Triple Negative breast cancer (TNBC) or patients who have an identified germline mutations (such as a mutation on the BRCA1 or BRCA2 genes).

Full description

This study is being done to collect cancer-related information from patients with triple negative breast cancer and patients with hereditary genetic mutations. This information will help us better understand the link between genetic changes and cancer outcome in patients with triple negative breast cancer.

Enrollment

1,500 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria include:

Triple Negative Breast Cancer

ER/PR <10% and HER negative per current ASCO/CAP guidelines
Stages I-IV
Any age at diagnosis
Patient must be within 5 years of diagnosis
Eligible regardless of genetic testing status
Genetic testing recommended for patients meeting NCCN and Medicare guidelines

AND/OR

Germline mutation Carriers

Patients with deleterious or uncertain mutations in HBOC genes (BRCA, PTEN, P53, -PALB2 etc) are eligible regardless of type/site of cancer
Healthy patients harboring mutations also eligible
There is no time limit from the time of diagnosis of cancer and enrollment.
Eligible regardless of personal history of cancer

Exclusion Criteria include:

Triple Negative Breast Cancer -Patient is not within five years of diagnosis

Germline mutation Carriers:

-Patient only carries a HBOC mutation that is classified as "polymorphism" of "favor polymorphism"