NCT05452213

Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients

CAPTOR-BC: Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Institut fuer Frauengesundheit · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label phase IV study of patients with advanced HR+/HER2- breast cancer who are treated first line with ribociclib and standard of care endocrine treatment according to SmPC.

Detailed description

This is a prospective, multicenter, phase IV, one-arm, open-label clinical trial investigating patients treated with ribociclib and standard of care endocrine therapy for hormone receptor positive (HR+) / human epidermal growth factor receptor negative (HER2-) advanced breast cancer in the first therapy line. Patients eligible for this trial will receive on-label ribociclib according to Summary of Product Characteristics (SmPC) and as well as the specified inclusion/exclusion criteria. The survival rates for progression-free survival (PFS) and overall survival (OS) at month 12 are the co-primary objectives. Quality of life and toxicity are secondary objectives. Additionally, there is a comprehensive biomarker discovery and validation program included into the study. A total of 1000 patients are planned to be enrolled into this trial in 75 trial sites in Germany. Biomarkers will be evaluated before, during and after treatment or at progression. A comprehensive biospecimens sampling will be done to enable translational research projects and evaluation of potential biomarkers within circulation tumor desoxyribonucleic acid (ctDNA), circulating tumor ribonucleic acid (ctRNA), formaldehyde-fixed paraffin-embedded tissue (FFPE) tissue, Serum, Plasma and circulating immune cells

Conditions

• Breast Cancer
• Breast Neoplasms
• Breast Neoplasm Female
• Breast Cancer Female
• HER2-negative Breast Cancer
• Hormone Receptor-positive Breast Cancer
• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Ribociclib	All patients will receive ribociclib in combination with standard endocrine therapy according to the current SmPC and local in-house standard. Ribociclib will be administered once daily for 21 consecutive days followed by 7 days off treatment (28-day cycle). The daily dose is 600 mg/day. Ribociclib and standard of care endocrine treatment will be prescribed and administered according to investigator's discretion.

Timeline

• Start date: 2022-10-12
• Primary completion: 2024-10-01
• Completion: 2026-10-01
• First posted: 2022-07-11
• Last updated: 2023-04-18

Locations

52 sites across 1 country: Germany