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Clinical Trials in Germany / NCT04767594
Active, not recruiting Observational

First-line Palbociclib and Endocrine Therapy for Patients With HR+/HER2- Advanced Breast Cancer in the Real-world Setting.

NCT04767594 · tracked via the Priya Life Science Germany tracker
Sponsor
Phase
Observational
Started
2020-10-27
Last updated
2026-04-13

Condition(s) studied

Breast Neoplasms

Investigational drug(s) / intervention(s)

Palbociclib + endocrine therapy →

Palbociclib + endocrine therapy: Palbociclib + letrozole, or Palbociclib + anastrozole, or Palbociclib + exemestane, or Palbociclib + fulvestrant after prior endocrine therapy In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.

Study summary

This is a prospective, single-arm, multi-center observational non-interventional study (NIS) in Germany and Austria.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. 2. Diagnosis of HR+/HER2- locally advanced, inoperable or metastatic breast cancer. 3. 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. 4. 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. 5. Age of 18 years or older. Patients meeting any of the following criteria will not be included in the study: 1. Any contraindication as per current local product label. 2. 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. 3. 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. 4. 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.

Primary outcome measure(s)

Trial sites (192)

FacilityCityRegionStatus
Sankt Josef Hospital Braunau Braunau am Inn Austria
Medizinische Universität Innsbruck Innsbruck Austria
Klinikum Klagenfurt am Woerthersee Klagenfurt Austria
Country Hospital Salzburg Salzburg Austria
Universitaetsklinikum Sankt Poelten Sankt Pölten Austria
Priv. Doz. OA Dr. Michael Hubalek Schwaz Austria
Medizinische Universität Wien, Abteilung Innere Medizin I Vienna Austria
Medizinische Universität Wien Vienna Austria
Oesterreichische Gesundheitskasse Hanusch-Krankenhaus Vienna Austria
Klinikum Bayreuth GmbH Bayreuth Bavaria
Klinikum Nürnberg Nuremberg Bavaria
Medizinische Universität Lausitz Carl Thiem Cottbus Brandenburg
Onkologische Kooperation Harz Goslar Lower Saxony
Johanniter-MVZ Bonn GmbH Bonn North Rhine-Westphalia
Caritas-Krankenhaus Bad Mergentheim Bad Mergentheim Other
Mvz Etgo Gmbh Berlin Other
Onkologisch-Hämatologische Schwerpunktpraxis Bremen Other
ANregiomed gKU Ansbach Germany
Alexianer Klinikum Hochsauerland GmbH Arnsberg Germany
Group practice Heinrich Augsburg Germany
Group Practice Steinfeld-Birg Augsburg Germany
Group practice Tanzer Bad Reichenhall Germany
Group practice Seipelt Bad Soden a.T. Germany
Klinikum Mittelbaden Baden-Baden Balg Baden-Baden Germany
Sozialstiftung Bamberg Klinikum am Bruderwald Bamberg Germany
Private Practice Bayreuth Bayreuth Germany
Charité Campus Mitte Berlin Germany
Hämatologie Onkologie Berlin-Mitte Berlin Germany
MediOnko-Institut GbR Berlin Germany
DRK Kliniken Berlin-Köpenick Brustzentrum Berlin Germany
Vivantes MVZ Hellersdorf - Zweigpraxis Biesdorf Berlin Germany
Group practice Morack Berlin Germany
Vivantes Netzwerk für Gesundheit GmbH Berlin Germany
Frauenarzt-Zentrum-Zehlendorf Berlin Germany
Dr. Leonid Basovski Hämatologikum Biberach Biberach an der Riss Germany
Evangelisches Klinikum Bethel gGmbH, Klinik für Innere Medizin, Hämatologie, Onkologie Bielefeld Germany
Group practice Bueckner Bochum Germany
Praxiskooperation Onkologie Bonn / Euskirchen / Rheinbach / Wesseling GbR Bonn Germany
Group practice Hannig Bottrop Germany
Marienhospital Bottrop gGmbH Bottrop Germany

+ 152 more sites — see the full list on the official registry below.

More Pfizer trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04767594 on ClinicalTrials.gov ↗ ← All trials in Germany