Triple Negative Breast Cancer Clinical Trial
— PERSONAOfficial title:
Evaluating the Feasibility of Next-Generation Sequencing - Based Germline and Somatic Genetic Testing in Triple-negative Breast Cancer. The PERSONA-breast Trial
NCT number | NCT03920488 |
Other study ID # | IEO 0761/ |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2018 |
Est. completion date | December 31, 2023 |
For patients with triple negative breast cancer, implementation of genetic testing in decision making might impact both risk management for the patient and her family, but also, importantly, therapeutic management. Identifying genetically predisposed subjects dictates risk-reducing strategies that may imply bilateral salpingo-oophorectomy and mastectomy or long term medical approaches. In the advanced setting, genetic testing can influence decision for medical therapy (e.g. use of platinum derivatives, poly-ADP ribose polymerase inhibitors (PARP inhibitors) in breast cancer patients with breast cancer susceptibility gene (BRCA) mutation. The selection of patients for testing has long relied on the presence of a strong family history of breast and ovarian cancer. It is now clear that this criterion will result in substantial numbers of those with a BRCA mutation being missed. Systematic large-scale genetic testing, simultaneously on germline and somatic tissues, is likely to improve decisional algorithms in patients with ovarian cancer. Feasibility of such approach in the clinical setting, in terms of a turnaround time compatible with clinical needs and sensitivity comparable if not superior to single-gene testing needs to be demonstrated before such diagnostic platforms can be routinely implemented in the diagnostic workflow. This is the scope of the present study.
Status | Recruiting |
Enrollment | 264 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. age between 18 and 60 years 2. has signed informed consent 3. histologically confirmed triple negative breast cancer (ER (Estrogen Receptors) < 1%, PgR (Progesterone Receptors) < 1%, HER2/neu negative (IHC 0, 1+ or 2+ FISH negative). 4. Stage I-III 5. Able to undergo surgery (primary or post-neoadjuvant) 6. Availability of surgical/bioptic material within 6 months from enrolment Exclusion Criteria: - unable or unwilling to receive genetic counselling |
Country | Name | City | State |
---|---|---|---|
Italy | Istituto Europeo di Oncologia | Milan |
Lead Sponsor | Collaborator |
---|---|
European Institute of Oncology |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of mutations in breast cancer risk-associated genes | Evaluate the prevalence of clinically relevant mutations in breast cancer risk-associated genes | 3 months | |
Primary | Genetic test turnaround time | Evaluate feasibility of genetic testing for clinical decision making | 6 months | |
Primary | Percentage of informative specimens | Percentage of patients with positive germline testing for target genes | 3 months | |
Secondary | Incidence of all other mutations | Incidence of all other mutations | 3 months | |
Secondary | disease-free survival | collection of disease associated events during follow-up | 10 years | |
Secondary | overall survival | collection of death events during follow-up | 10 years |
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