Information sheet on the clinical trial - CAPTOR BC

Main indication

Breast cancer

 

Study name (study type)

CAPTOR BC Study

Study sponsor

NOVARTIS

Registration number

Sponsor Protocol Number: IFG-01-000637-16 EudraCT: 2022-000637-16

FOR URGENT READERS:

This study is for patients with locally advanced and/or metastatic HR+/HER2- breast cancer undergoing treatment with ribociclib in combination with endocrine therapy.

DETAILED INFORMATION:

Study Title

CAPTOR-BC Study on the treatment of combination therapy with ribociclib and endocrine therapy in Phase IV breast cancer. 

Which conditions are being treated in this study?

Breast cancer

Are specific subgroups of patients with one of the mentioned conditions being treated?

Patients with HR+/HER2- negative breast cancer  

Background on the study medication

Ribociclib in combination with endocrine therapy has yielded demonstrably outstanding study data in recent years; the combination of endocrine therapy and CDK4/6 inhibitors now forms the foundation of first-line therapy.

Study Protocol

After enrollment in this study, patients will receive ribociclib in combination with endocrine therapy. Treatment will continue until disease progression or intolerable toxicity (max. 5 years). Treatment response will be documented, and patients will assess their quality of life using an online questionnaire. 

Inclusion Criteria

• Patients with HR+/HER2- advanced and/or metastatic breast cancer 
• Patients who are 18 years of age or older

Exclusion criteria

• Patients with active systemic infection
• Patients with serious pre-existing medical conditions
• The patient is currently participating in another clinical trial and is receiving active treatment

Your contacts: Investigators at the center and contact information

Dr. Andriana Haus

Email: haus@~@gp-ruesselsheim.de

Phone: 06142 88-1223

Staff members in charge at the study clinic

Heike Borchert (Study Coordinator)

Email: borchert@~@gp-ruesselsheim.de

Phone: 06142 88-1032