Assessing breast cancer outcomes in patients with PALB2 mutations
Assessing Clinical Features and Outcome of Breast Cancer in PALB2
This study is trying to see how breast cancer affects people with PALB2 mutations compared to those without the mutation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliero-Universitaria di Modena Academic / other |
| Locations | 1 site (Modena) |
| Trial ID | NCT06403904 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical features and outcomes of breast cancer in patients with PALB2 mutations. It will enroll at least 300 patients diagnosed with breast cancer who carry the PALB2 mutation and compare them to a control group of 300 breast cancer patients without mutations. Data collected will include demographic information, tumor characteristics, and treatment details. The study is conducted across multiple institutions with expertise in hereditary breast cancer, and it is expected to complete enrollment within a year, followed by a minimum one-year follow-up for analysis.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed breast cancer who have a documented deleterious PALB2 mutation.
Not a fit: Patients with benign variants of the PALB2 gene or variants of uncertain significance will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the specific risks and treatment outcomes for breast cancer patients with PALB2 mutations.
How similar studies have performed: While studies on BRCA mutations have shown success, this specific focus on PALB2 mutations is relatively novel and less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- 1. Has a histologically or cytologically confirmed breast cancer 2. Has any stage of BC 3. Has documented mutation in PALB2 gene (germline or somatic) that is predicted to be deleterious or suspected deleterious. 4\. Has a multigene test performed and resulted negative for alterations. 5. Has information on tumours characteristics, modality of diagnosis, type of surgical treatment, medical therapy, family history and eventually second primary tumours Demographics Is male or female, who is at least 18 years of age at the time of signing the informed consent. Exclusion Criteria: Has a benign variant of PALB2 gene or variant of uncertain (or unknown) significance (VUS) Is involved in the planning and/or conduct of the study Is judged by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements. \-
Where this trial is running
Modena
- Aou Modena — Modena, Italy (Recruiting)
Study contacts
- Principal investigator: Laura Cortesi, Md — Azienda Ospedaliero Universitaria Policlinico Modena
- Study coordinator: LAURA CORTESI, md
- Email: hbc@unimore.it
- Phone: +39 059 422 4334
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.