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Recruiting NCT05748353

Endocrine Disruptors and Life STILe in Breast Cancer Development

Conditions: Breast Cancer, BRCA1 Mutation, BRCA2 Mutation, Ovarian Cancer, Life Style, Cadmium Exposure

Sex: Female
Ages: 18 Years – 80 Years
Enrollment: 275
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Location: Italy

Summary

The aim of the study is to evaluate the role of lifestyle and environmental factors ( environmental contaminants such as Cd) on the penetrance of BRCA1/2 genes in BRCAm patients with Breast cancer and/or Ovarian cancer and in BRCAm healthy women without cancer diagnosis

Eligibility Criteria

Inclusion Criteria:Age>18 yearsHistologic diagnosis of early-stage BC (stage I, II, III operated; luminal, HER2+, triple-negative tumors) or OC (high-grade epithelial any stage and histotype); presence of germline variant of BRCA1 or BRCA2, class 4 or 5Patients carrying germline variant of BRCA1 or BRCA2, class 4 or 5, in the absence of BC and/or OC, who have not undergone prophylactic mastectomy and/or bilateral ovariectomy surgery.Patients with malignancy must have undergone surgery and be currently disease-free or in complete or partial remission in the case of OC.Adjuvant/neoadjuvant systemic therapy as well as maintenance therapy (PARP-inhibitors for example) is permitted.Signature of informed consent.ECOG: 0.1.Compliance with questionnaire completionExclusion Criteria:Prophylactic breast or ovarian surgeryGerminal variant of BRCA1 or BRCA2, class 1,2, 3.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05748353). StuddyBuddy aggregates publicly available trial information.