Prevalence of emerging treatment-induced mutations in metastatic ER-positive breast cancer. - Pangeia-2

Inclusion Criteria

• Cohort 1:
• • BC patients, male and female, 18 years old and older, pre or post menopausal,
• with HR+ (ER and/or PR positive), Her-2 negative (confirmed centrally)
• locally advanced irresectable and/or metastatic disease
• • Confirmation of HR and Her-2 status may be performed in the primary tumor
• or in the metastatic lesion (patients with discordant results may be included)
• • Patients must be candidates to CDK4/6i therapy in combination with endocrine
• therapy in the first line setting (with or without ovarian suppression)
• • Patients may have received one previous line of chemotherapy in the metastatic
• setting, but no endocrine therapy in the metastatic setting is allowed
• • Patients may have received chemotherapy in the neo/adjuvant setting
• • Patients may have received endocrine therapy (with or without ovarian
• suppression) in the neo/adjuvant setting
• • Patients may have received a CDK4/6i in the adjuvant setting, provided they
• are still candidates for CDK4/6i therapy in the metastatic setting
• • Patients must be able to undergo a liquid biopsy procedure before starting their
• first line treatment
• • All patients must fill and sign an informed consent form.
• Cohort 2:
• • BC patients, male and felame, 18 years old and older, pre or post menopausal,
• with HR+ (ER and/or PR positive), Her-2 negative (confirmed centrally)
• locally advanced irresectable and/or metastatic disease who have progressed on
• a CDK4/6i in combination with endocrine therapy (with or without ovarian
• suppression) in the first or second line setting
• • All other non-conflicting inclusion criteria for cohort 1 apply.