Observing mutations in metastatic ER-positive breast cancer patients
PANGEIA-2: Prevalence of Emerging Treatment-induced Mutations in metastaticER Positive Breast Cancer.
This study looks at how certain genetic changes in metastatic ER-positive breast cancer patients happen over time, by comparing blood tests and tissue samples from those who have and haven’t had treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT06417801 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the prevalence of emerging ESR1 mutations in patients with metastatic ER-positive breast cancer through liquid biopsies. It involves two cohorts: one with prior therapies and one without, comparing their mutation status to baseline tissue profiling. The study utilizes next-generation sequencing (NGS) methodologies to analyze both liquid and tissue biopsies for specific genetic mutations. The goal is to understand how treatment influences mutation development in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults with HR-positive, Her-2 negative metastatic breast cancer who are candidates for CDK4/6 inhibitor therapy.
Not a fit: Patients who have not been diagnosed with metastatic breast cancer or those who have already received endocrine therapy in the metastatic setting may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the genetic changes associated with treatment in metastatic breast cancer, potentially guiding more effective therapies.
How similar studies have performed: Other studies have explored similar genetic mutations in breast cancer, indicating a growing interest in this area, though the specific focus on ESR1 mutations in this context may be novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
São Paulo
- Research Site — São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Rodrigo Dienstmann — Oncoclínicas
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
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.