Information sheet on the clinical study - PERFORM

Main indication

Breast cancer

 

Study name (study type)

PERFORM (non-interventional study) 

Study sponsor

Pfizer

Registration number

FOR RAPID READERS:

Study for patients with blood cancer. Treatment data and questionnaires will be collected from the patients. This is an observational study and will not influence the treatment method prescribed by the doctor

DETAILED INFORMATION:

Study Title

An epidemiological, prospective observational study to investigate the real-world care of patients with HR+/HER2- advanced breast cancer who are treated in the first line with an endocrine-based palbociclib combination therapy according to current treatment standards

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

Palbociclib is a highly selective oral CDK-4/6 inhibitor and is indicated for the treatment of patients with HR+/HER2- advanced breast cancer in combination with an aromatase inhibitor or in combination with fulvestrant in patients who have previously received endocrine therapy

Study Protocol

Patients are enrolled in first-line combination therapy with palbociclib and an aromatase inhibitor or fulvestrant. First-line treatment is followed by monitoring of subsequent therapies until patients have completed their study participation

Inclusion criteria

• Patients with HR+/HER2- advanced, inoperable, or metastatic breast cancer 
• Patients receiving endocrine-based palbociclib combination therapy as first-line treatment
• Patients who are 18 years of age or older

Exclusion criteria

• Patients with any contraindication
• Patients who have previously received systemic antineoplastic therapy for advanced disease
• 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