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Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry

PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

PROGECT is a registry that collects information about patients, rather than testing a treatment. It is for people with triple negative breast cancer or inherited gene changes linked to breast and ovarian cancer, such as changes in BRCA1 or BRCA2.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You may qualify through either the breast cancer group or the inherited gene change group.
  • Breast cancer group: Tests must show ER and PR levels below 10% and a negative HER2 result, under current guidelines.
  • Breast cancer group: Any stage, from I to IV, and any age at diagnosis are allowed.
  • Breast cancer group: You must join within 5 years of diagnosis.
  • Breast cancer group: You can join whether or not you have had genetic testing.
  • Gene change group: You must have an inherited change in a gene linked to breast and ovarian cancer, such as BRCA, PTEN, P53, or PALB2. The change may be harmful or have an unknown effect.
  • Gene change group: You can join with any type of cancer or with no history of cancer, including if you are healthy.
  • Gene change group: There is no time limit after a cancer diagnosis.

Who can't join

  • Breast cancer group: You were diagnosed more than 5 years ago.
  • Gene change group: Your only gene change is labeled a “polymorphism” or “favor polymorphism,” meaning a common gene difference or one thought likely to be common.

Simplified for readability. The official criteria below are what the study team uses.

Official 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"

Study sites (11)

KS

MO