Status:
ACTIVE_NOT_RECRUITING
First-line Palbociclib and Endocrine Therapy for Patients With HR+/HER2- Advanced Breast Cancer in the Real-world Setting.
Lead Sponsor:
Pfizer
Conditions:
Breast Neoplasms
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective, single-arm, multi-center observational non-interventional study (NIS) in Germany and Austria.
Detailed Description
Patients diagnosed with HR+/HER2- locally advanced or metastatic breast cancer indicated by their treating physicians for first line endocrine-based palbociclib combination therapy and who meet eligib...
Eligibility Criteria
Inclusion
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
- Diagnosis of HR+/HER2- locally advanced, inoperable or metastatic breast cancer.
- Physician has determined that first-line treatment with palbociclib (i) in combination with an aromatase inhibitor, or (ii) in combination with fulvestrant in women who received prior endocrine therapy as per current local product label is indicated. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.
- Patients who in the opinion of the investigator are willing and able to comply with regular clinic visits as per local standard of care practice at the study site.
- Age of 18 years or older.
- Patients meeting any of the following criteria will not be included in the study:
- Any contraindication as per current local product label.
- Prior systemic antineoplastic treatment for advanced disease. Exception: Start of first line treatment with palbociclib in combination with aromatase inhibitor or fulvestrant as per current local product label is allowed up to 4 weeks prior to inclusion.
- Patients currently participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. Note: A concomitant participation in other non-interventional/observational studies, registries and translational research networks (e.g., PRAEGNANT, OPAL) or chart reviews is allowed.
- Patients who are unable to understand the nature of the study or are unwilling to sign an informed consent.
- Patient eligibility should be reviewed, documented, and confirmed by an appropriately qualified member of the investigator's study team before patients are enrolled in the study.
Exclusion
Key Trial Info
Start Date :
October 27 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2029
Estimated Enrollment :
1409 Patients enrolled
Trial Details
Trial ID
NCT04767594
Start Date
October 27 2020
End Date
April 30 2029
Last Update
July 8 2025
Active Locations (191)
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1
Sankt Josef Hospital Braunau
Braunau am Inn, Austria, 5280
2
Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
3
Klinikum Klagenfurt am Woerthersee
Klagenfurt, Austria, 9020
4
Country Hospital Salzburg
Salzburg, Austria, 5020