Endocrine Disruptors and Life STILe in Breast Cancer Development (NCT05748353) | Clinical Trial Compass
UnknownNot Applicable
Endocrine Disruptors and Life STILe in Breast Cancer Development
Italy275 participantsStarted 2012-01-01
Plain-language 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
Who can participate
Age range18 Years – 80 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age\>18 years
* Histologic 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 5
* Patients 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 completion
Exclusion Criteria:
* Prophylactic breast or ovarian surgery
* Germinal variant of BRCA1 or BRCA2, class 1,2, 3.