Clinical trial NCT02302742: Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry
Official title: PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Hereditary Breast and Ovarian Cancer
Keywords: Triple Negative Breast Cancer
TNBC
Hereditary Breast and Ovarian Cancer
HBOC
Prospective Registry
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Academic Center \& Community Clinics

Brief summary: 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).

Detailed 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.

Eligibility 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"

Primary outcomes:
measure: Prevalence of germline mutations (such as BRCA1/2 mutations) in patients with TNBC
timeFrame: 5 years
measure: . Predictors of response to neo/adjuvant chemotherapy in patients with TNBC
timeFrame: 5 years
measure: Long term Disease free and overall survival rates in TNBC patients treated with different systemic therapies
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hays
country: United States
facility: Hays Medical Center Dreiling-Schmidt Cancer Institute
state: Kansas
city: Kansas City
country: United States
facility: KCCC West
state: Kansas
city: Overland Park
country: United States
facility: Menorah Medical Center
state: Kansas
city: Overland Park
country: United States
facility: KCCC Overland Park
state: Kansas
city: Overland Park
country: United States
facility: Overland Park Regional Medical Center
state: Kansas
city: Salina
country: United States
facility: Salina Regional Health Center - Tammy Walker Cancer Center
state: Kansas
city: Westwood
country: United States
facility: The University of Kansas Cancer Center
state: Kansas
city: Independence
country: United States
facility: Centerpoint Regional Medical Center
state: Missouri
city: Kansas City
country: United States
facility: Truman Medical Center
state: Missouri
city: Kansas City
country: United States
facility: KCCC South
state: Missouri
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Kansas City
country: United States
facility: KCCC - North
state: Missouri
city: Lee's Summit
country: United States
facility: KCCC Lee's Summit
state: Missouri
Study officials:
affiliation: The University of Kansas Medical Center
name: Priyanka Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharma P, Klemp JR, Kimler BF, Mahnken JD, Geier LJ, Khan QJ, Elia M, Connor CS, McGinness MK, Mammen JM, Wagner JL, Ward C, Ranallo L, Knight CJ, Stecklein SR, Jensen RA, Fabian CJ, Godwin AK. Germline BRCA mutation evaluation in a prospective triple-negative breast cancer registry: implications for hereditary breast and/or ovarian cancer syndrome testing. Breast Cancer Res Treat. 2014 Jun;145(3):707-14. doi: 10.1007/s10549-014-2980-0. Epub 2014 May 7.
citation: Connor CS, Kimler BF, Mammen JM, McGinness MK, Wagner JL, Alsop SM, Ward C, Fabian CJ, Khan QJ, Sharma P. Impact of neoadjuvant chemotherapy on axillary nodal involvement in patients with clinically node negative triple negative breast cancer. J Surg Oncol. 2015 Feb;111(2):198-202. doi: 10.1002/jso.23790. Epub 2014 Sep 29.