Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry
Recruiting · NCT02302742 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Kansas Medical Center
View the official record on ClinicalTrials.gov →What this trial is 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).
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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"
Where it is running
11 locations listed across 2 US states.
- Hays Medical Center Dreiling-Schmidt Cancer Institute - Hays, Kansas, United States
- KCCC West - Kansas City, Kansas, United States
- KCCC Overland Park - Overland Park, Kansas, United States
- Overland Park Regional Medical Center - Overland Park, Kansas, United States
- Salina Regional Health Center - Tammy Walker Cancer Center - Salina, Kansas, United States
- The University of Kansas Cancer Center - Westwood, Kansas, United States
- Universtiy Health - Kansas City, Missouri, United States
- KCCC South - Kansas City, Missouri, United States
- Research Medical Center - Kansas City, Missouri, United States
- KCCC - North - Kansas City, Missouri, United States
- KCCC Lee's Summit - Lee's Summit, Missouri, United States