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Completed NCT04937660

Treatment Patterns & Clinical Outcomes of Palbociclib Combinations in HR+HER2-MBC

Conditions: Metastatic Breast Cancer

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 185
Sponsor: Pfizer

Location: Alexandria School of Medicine/Clinical Research Center CRC Alexandria

Summary

The objective of this non-interventional multicenter study is to provide prospective, observational data on patients initiating treatment with palbociclib combination to contribute to the knowledge of HR+ HER2-metastatic/locally advanced Breast Cancer (BC) disease management, its treatment pattern, clinical outcomes and quality of life (QoL) in the routine clinical practice in Africa and Middle East countries .

Eligibility Criteria

Inclusion Criteria: 1. ≥18 years or older with diagnosis of adenocarcinoma of the breast with evidence of metastatic /locally advanced disease not amenable to treatment with curative intent. 2. Documented HR+ (ER+ and/or PR+) tumor based on local standards 3. Documented HER2- tumor based on local standards 4. Will initiate treatment with palbociclib plus letrozole/aromatase inhibitor or palbociclib plus fulvestrant in line with the licensed indication(s), as first or second line therapy for metastatic/locally advanced BC at enrollment 5. Patients who in the opinion of the investigator are willing and able to comply with regular clinic visits 6. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study Exclusion Criteria: 1. Patients participating in any interventional clinical trial 2. Patients on active treatment for malignancies other than metastatic/locally advanced BC at the time of enrollment 3. Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04937660). StuddyBuddy aggregates publicly available trial information.