Prevalence of Emerging Treatment-induced Mutations in Metastatic ER-positive Breast Cancer.

Launched by ASTRAZENECA · May 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the presence of specific mutations (changes in genes) in patients with metastatic breast cancer, particularly those with estrogen receptor-positive (ER+) and HER2-negative types. Researchers want to see how often these mutations, known as ESR1 mutations, appear after patients receive certain treatments. The study will involve two groups of patients: one group will include those who are starting a new treatment, and the other group will include patients who have already been treated but have not seen improvements.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with advanced breast cancer that cannot be surgically removed. They should also be candidates for specific treatments involving hormone therapy and CDK4/6 inhibitors, which are medications that help control cancer growth. Participants will undergo a simple procedure called a liquid biopsy, which involves taking a blood sample to check for these mutations. Throughout the trial, participants will be informed and must agree to take part by signing a consent form. This study will help researchers understand how treatment may change the genetic makeup of breast cancer and potentially improve future treatment options.

Gender

ALL

Eligibility criteria

• 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.
• Exclusion Criteria:
• • Patients with HR+ (ER and/or PR positive) and Her-2 negative disease NOT confirmed centrally
• • Patients with NO radiologic and/or pathologic confirmed locally irresectable and/or metastatic breast cancer
• • Patients who are NOT candidates for further systemic treatment after diagnosis of metastatic disease or disease progression
• • Patients who have already started a CDK4/6i in combination with endocrine therapy (with or without ovarian suppression) for metastatic disease in the first line setting (for cohort 1); and patients who have already started a new line of treatment for metastatic disease after disease progression on a CDK4/6i in combination with endocrine therapy (with or without ovarian suppression)(for cohort 2)
• • Patients who are NOT able to undergo a liquid biopsy procedure
• • Patients who are NOT able to provide informed consent.