Clinical trial NCT06311383: A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Ribociclib + AI/FUL, or With Endocrine Therapy or Chemotherapy as First Line Treatment
Official title: A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor/Fulvestrant, or With Endocrine Therapy or Chemotherapy as First Line Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer
NIS
Ribociclib
Metastatic Breast Cancer
HR+
HER2-
Real World Evidence
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-03-15
Enrollment: 2615
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult females with HR+/HER2- locally advanced/metastatic breast cancer (progressed following prior therapy or de novo). Hereby locally advanced is defined by the following criteria (at least one must apply): tumor size \> 5 cm (T3), skin or chest wall infiltration (T4a, T4b), inflammatory breast cancer (T4c), fixed axilla-located lymph node conglomerate or intraclavicular lymph node metastasis (cN3; German S3 guideline for early detection, diagnosis, therapy and follow-up care of breast cancer; Version 4.1.2018). Patients are classified as therapy naïve for locally advanced/metastatic disease if they have not yet received a systemic therapy in the palliative setting. Patients with locally advanced breast cancer who have received therapy-(lines) in the adjuvant/curative setting are eligible after progression to e.g. a metastatic breast cancer. All patients who already received a palliative therapy for locally advanced/metastatic breast cancer are excluded from study participation.

Brief summary: This is a non-interventional observational study conducted in Germany to evaluate the real-world effectiveness, tolerability, safety, and quality of life in patients with locally advanced/metastatic HR+/HER2- breast cancer treated with one of the following 1st line treatments: Ribociclib + AI/FUL, or endocrine monotherapy, or chemotherapy

Detailed description: This non-interventional study collects data from clinical practice capturing on effectiveness, safety and tolerability, duration of therapy, and quality of life of ribociclib in combination with an aromatase inhibitor/fulvestrant in daily routine and in line with the respective current German summary of product characteristics. In order to put these results into perspective, data is also collected on patients treated with endocrine therapy or chemotherapy for first line locally advanced or metastatic breast cancer. To gain insight into algorithms and outcome of sequential therapy, up to three lines of treatment are documented within this study. The information gathered and evaluated in this NIS is helping to answer open questions for the treatment of locally advanced/metastatic breast cancer and provides first insights into the treatment reality with ribociclib in this setting. This includes, but is not limited to, the questions on baseline demographics leading to a specific treatment decision, as well as efficacy and clinical routine related to treatment sequencing. In addition, data on the mutation status (including PIK3CA and BRCA1/2) is collected at different time points to generate insights into the clinical routine of mutation testing and to understand its impact on therapy sequencing.

Eligibility criteria: Inclusion Criteria:

* Patients with a histological diagnosis of locally advanced/metastatic HR+/HER2- breast cancer. Histological diagnosis does not necessarily origin from metastasis, but must reflect the most recent disease status
* No prior systemic treatment for locally advanced/metastatic disease in the palliative setting
* The treating physician has made the decision to treat the patient
* with ribociclib in combination with an aromatase inhibitor or fulvestrant as initial treatment in first line, or
* endocrine therapy as initial treatment in first line (e.g. letrozole, anastrozole, fulvestrant), or
* chemotherapy as initial treatment in first line (e.g. taxanes, capecitabine, with or without bevacizumab)
* Written informed consent of the patient
* Patient who initiated treatment for first line no longer than 4 weeks (28 days) prior to written informed consent for this study
* Planned treatment is in line with the respective current German SmPC ("Summary of product characteristics")
* Patient is ≥18 years

Exclusion Criteria:

* Patients unable to provide written informed consent
* Contra-indication according to the respective current German SmPC ("Summary of product characteristics"), as judged by the treating physician
* The patient is currently under active treatment in an investigational study

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to 88 months
Secondary outcomes:
measure: Cox proportional hazard regression for progression free survival in 1st line therapy
timeFrame: Up to 88 months
measure: Propensity Score matching for progression free survival in 1st line therapy
timeFrame: Up to 88 months
measure: Sequential progression-free survival (PFS_S)
timeFrame: Up to 88 months
measure: Conditional progression-free survival
timeFrame: Up to 88 months
measure: Time to treatment failure (TTF)
timeFrame: Up to 88 months
measure: Time to first chemotherapy
timeFrame: Up to 88 months
measure: Time to next treatment / therapy (TTNT) after 1st line treatment
timeFrame: Up to 88 months
measure: Overall survival (OS)
timeFrame: Up to 88 months
measure: Dose reduction
timeFrame: Up to 88 months
measure: Dose interruption
timeFrame: Up to 88 months
measure: Discontinuations
timeFrame: Up to 88 months
measure: Adherence - MMAS-8 questionnaire
timeFrame: Up to 87 weeks
measure: Number of participants with mutations
timeFrame: Up to 88 months
measure: Quality of life for specific cohorts and treatment lines - EORTC QLQ-C30
timeFrame: Up to 88 months
measure: Quality of life for specific cohorts and treatment lines - EORTC QLQ-B23
timeFrame: Up to 88 months
measure: Quality of life for specific cohorts and treatment lines - HADS-D
timeFrame: Up to 88 months
Other outcomes:
Locations:
city: Baden Baden
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Freudenstadt
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Heidenheim An Der Brenz
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Karlsruhe
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Mannheim
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Mutlangen
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Nuertingen
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Reutlingen
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Schwaebisch
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Sigmaringen
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Winnenden
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Ostfildern
country: Germany
facility: Novartis Investigative Site
state: Baden Wurttemberg
city: Rottweil
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Augsburg
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Bamberg
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Muenchen
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Altoetting
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Amberg
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Ansbach
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Aschaffenburg
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Bayreuth
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Donauwoerth
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Ebersberg
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Eggenfelden
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Landshut
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Muenchen
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Muenchen
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Nuernberg
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Regensburg
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Straubing
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Wuerzburg
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Mannheim
country: Germany
facility: Novartis Investigative Site
state: Beden Wuerttenberg
city: Doberlug Kirchhain
country: Germany
facility: Novartis Investigative Site
state: Brandenburg
city: Fuerstenwalde
country: Germany
facility: Novartis Investigative Site
state: Brandenburg
city: Ludwigsfelde
country: Germany
facility: Novartis Investigative Site
state: Brandenburg
city: Neu-Brandenburg
country: Germany
facility: Novartis Investigative Site
state: Brandenburg
city: Spremberg
country: Germany
facility: Novartis Investigative Site
state: Brandenburg
city: Bremerhaven
country: Germany
facility: Novartis Investigative Site
state: Bremen
city: Bad Homburg
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facility: Novartis Investigative Site
state: Hessen
city: Bad Nauheim
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Darmstadt
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Erbach
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Frankfurt am Main
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Frankfurt am Main
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Frankfurt am Main
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Langen
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facility: Novartis Investigative Site
state: Hessen
city: Lich
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facility: Novartis Investigative Site
state: Hessen
city: Marburg
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facility: Novartis Investigative Site
state: Hessen
city: Arnsberg
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facility: Novartis Investigative Site
state: Hochsauerland
city: Twistringen
country: Germany
facility: Novartis Investigative Site
state: Lower Saxony
city: Rostock
country: Germany
facility: Novartis Investigative Site
state: Mecklenburg Vorpommern
city: Schwerin
country: Germany
facility: Novartis Investigative Site
state: Mecklenburg Vorpommern
city: Stralsund
country: Germany
facility: Novartis Investigative Site
state: Mecklenburg Vorpommern
city: Braunschweig
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Buchholz in der Nordheide
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Damme
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Georgsmarienhuette
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Hameln
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Hannover
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Lingen
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Osnabrueck
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Quedlinburg
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Westerstede
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Wolfenbuettel
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Bergisch Gladbach
country: Germany
facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Bochum
country: Germany
facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Bonn
country: Germany
facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Bonn
country: Germany
facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Dortmund
country: Germany
facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Gelsenkirchen
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facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Herdecke
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facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Hilden
country: Germany
facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Krefeld
country: Germany
facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Lemgo
country: Germany
facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Olpe
country: Germany
facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Paderborn
country: Germany
facility: Novartis Investigative Site
state: Nordrhein Westfalen
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facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Troisdorf
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facility: Novartis Investigative Site
state: Nordrhein Westfalen
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facility: Novartis Investigative Site
state: Nordrhein Westfalen
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facility: Novartis Investigative Site
state: Nordrhein Westfalen
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country: Germany
facility: Novartis Investigative Site
state: Nordrhein Westfalen
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facility: Novartis Investigative Site
state: Nordrhein Westphalen
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facility: Novartis Investigative Site
state: Nordrhein-Westfalen
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facility: Novartis Investigative Site
state: Nordrhein-Westfalen
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facility: Novartis Investigative Site
state: Nordrhein-Westfalen
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facility: Novartis Investigative Site
state: North Rhine-Westphalia
city: Hagen
country: Germany
facility: Novartis Investigative Site
state: Northrhine Westfalia
city: Remscheid Innen
country: Germany
facility: Novartis Investigative Site
state: Northrhine Westfalia
city: Mayen
country: Germany
facility: Novartis Investigative Site
state: Rheinland Pfalz
city: Simmern
country: Germany
facility: Novartis Investigative Site
state: Rheinland Pfalz
city: Neustadt
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facility: Novartis Investigative Site
state: Rheinland-Pfalz
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
state: Sachsen Anhalt
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
state: Sachsen Anhalt
city: Halle Saale
country: Germany
facility: Novartis Investigative Site
state: Sachsen-Anhalt
city: Dresden
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facility: Novartis Investigative Site
state: Sachsen
city: Dresden
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facility: Novartis Investigative Site
state: Sachsen
city: Leipzig
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facility: Novartis Investigative Site
state: Sachsen
city: Pirna
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facility: Novartis Investigative Site
state: Sachsen
city: Rodewisch
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facility: Novartis Investigative Site
state: Sachsen
city: Scheibenberg
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facility: Novartis Investigative Site
state: Sachsen
city: Schkeuditz
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facility: Novartis Investigative Site
state: Sachsen
city: Zittau
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facility: Novartis Investigative Site
state: Sachsen
city: Zxickau
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facility: Novartis Investigative Site
state: Sachsen
city: Flensburg
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facility: Novartis Investigative Site
state: Schleswig Holstein
city: Luebeck
country: Germany
facility: Novartis Investigative Site
state: Schleswig-Holstein
city: Apolda
country: Germany
facility: Novartis Investigative Site
state: Thueringen
city: Eisenach
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facility: Novartis Investigative Site
state: Thueringen
city: Erfurt
country: Germany
facility: Novartis Investigative Site
state: Thueringen
city: Meinigen
country: Germany
facility: Novartis Investigative Site
state: Thueringen
city: Suhl
country: Germany
facility: Novartis Investigative Site
state: Thueringen
city: Altoetting
country: Germany
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Bad Liebenwerda
country: Germany
facility: Novartis Investigative Site
city: Bamberg
country: Germany
facility: Novartis Investigative Site
city: Bayreuth
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
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facility: Novartis Investigative Site
city: Bochum
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facility: Novartis Investigative Site
city: Boeblingen
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facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Bottrop
country: Germany
facility: Novartis Investigative Site
city: Brandenburg an der Havel
country: Germany
facility: Novartis Investigative Site
city: Brandenburg
country: Germany
facility: Novartis Investigative Site
city: Bremen
country: Germany
facility: Novartis Investigative Site
city: Bremen
country: Germany
facility: Novartis Investigative Site
city: Bremen
country: Germany
facility: Novartis Investigative Site
city: Bremerhaven
country: Germany
facility: Novartis Investigative Site
city: Celle
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Cottbus
country: Germany
facility: Novartis Investigative Site
city: Dessau-Rosslau
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Erfurt
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Esslingen
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facility: Novartis Investigative Site
city: Eutin
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facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Friedberg
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facility: Novartis Investigative Site
city: Friedrichshafen
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facility: Novartis Investigative Site
city: Gera
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facility: Novartis Investigative Site
city: Goch
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facility: Novartis Investigative Site
city: Goettingen
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facility: Novartis Investigative Site
city: Goettingen
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facility: Novartis Investigative Site
city: Goslar
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facility: Novartis Investigative Site
city: Greifswald
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facility: Novartis Investigative Site
city: Gummersbach
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facility: Novartis Investigative Site
city: Halberstadt
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facility: Novartis Investigative Site
city: Hamburg
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facility: Novartis Investigative Site
city: Hamburg
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facility: Novartis Investigative Site
city: Hamburg
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city: Hamburg
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city: Hamburg
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city: Hamburg
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facility: Novartis Investigative Site
city: Hameln
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city: Hanau
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facility: Novartis Investigative Site
city: Hannover
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facility: Novartis Investigative Site
city: Hannover
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facility: Novartis Investigative Site
city: Hannover
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city: Hildesheim
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facility: Novartis Investigative Site
city: Hof
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facility: Novartis Investigative Site
city: Homburg
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facility: Novartis Investigative Site
city: Ilsede
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city: Kaiserslautern
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city: Karlsruhe
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facility: Novartis Investigative Site
city: Kassel
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facility: Novartis Investigative Site
city: Kempten
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facility: Novartis Investigative Site
city: Kiel
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facility: Novartis Investigative Site
city: Koblenz
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facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Koeln
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facility: Novartis Investigative Site
city: Koeln
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facility: Novartis Investigative Site
city: Kronach
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facility: Novartis Investigative Site
city: Krumbach
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facility: Novartis Investigative Site
city: Kulmbach
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facility: Novartis Investigative Site
city: Lebach
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facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leipzig
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facility: Novartis Investigative Site
city: Loerrach
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facility: Novartis Investigative Site
city: Lohsa Weisskollm
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facility: Novartis Investigative Site
city: Luebeck
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facility: Novartis Investigative Site
city: Mainz
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facility: Novartis Investigative Site
city: Mannheim
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city: Mannheim
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city: Marburg
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facility: Novartis Investigative Site
city: Marktredwitz
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city: Memmingen
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facility: Novartis Investigative Site
city: Minden
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city: Moenchengladbach
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facility: Novartis Investigative Site
city: Moers
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facility: Novartis Investigative Site
city: Muehlhausen
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facility: Novartis Investigative Site
city: Muenster
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facility: Novartis Investigative Site
city: Naunhof
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facility: Novartis Investigative Site
city: Neuruppin
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facility: Novartis Investigative Site
city: Neuss
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facility: Novartis Investigative Site
city: Neuss
country: Germany
facility: Novartis Investigative Site
city: Neustadt Sachsen
country: Germany
facility: Novartis Investigative Site
city: Nordhausen
country: Germany
facility: Novartis Investigative Site
city: Nuernberg
country: Germany
facility: Novartis Investigative Site
city: Nuernberg
country: Germany
facility: Novartis Investigative Site
city: Offenbach
country: Germany
facility: Novartis Investigative Site
city: Offenburg
country: Germany
facility: Novartis Investigative Site
city: Oldenburg
country: Germany
facility: Novartis Investigative Site
city: Osnabrueck
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facility: Novartis Investigative Site
city: Passau
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facility: Novartis Investigative Site
city: Pforzheim
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facility: Novartis Investigative Site
city: Plauen Kauschwitz
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facility: Novartis Investigative Site
city: Potsdam
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city: Ravensburg
country: Germany
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city: Regensburg
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facility: Novartis Investigative Site
city: Rheine
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facility: Novartis Investigative Site
city: Rodgau
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facility: Novartis Investigative Site
city: Rosenheim
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city: Rostock
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facility: Novartis Investigative Site
city: Rostock
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facility: Novartis Investigative Site
city: Rotenburg
country: Germany
facility: Novartis Investigative Site
city: Ruesselsheim
country: Germany
facility: Novartis Investigative Site
city: Saarbruecken
country: Germany
facility: Novartis Investigative Site
city: Saarlouis
country: Germany
facility: Novartis Investigative Site
city: Salzgitter
country: Germany
facility: Novartis Investigative Site
city: Schkeuditz
country: Germany
facility: Novartis Investigative Site
city: Schorndorf
country: Germany
facility: Novartis Investigative Site
city: Schwaebisch Hall
country: Germany
facility: Novartis Investigative Site
city: Schweinfurt
country: Germany
facility: Novartis Investigative Site
city: Schwerte
country: Germany
facility: Novartis Investigative Site
city: Soest
country: Germany
facility: Novartis Investigative Site
city: Stade
country: Germany
facility: Novartis Investigative Site
city: Stendal
country: Germany
facility: Novartis Investigative Site
city: Stolberg
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Suhl
country: Germany
facility: Novartis Investigative Site
city: Torgau
country: Germany
facility: Novartis Investigative Site
city: Trier
country: Germany
facility: Novartis Investigative Site
city: Tuebingen
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Vechta
country: Germany
facility: Novartis Investigative Site
city: Voelklingen
country: Germany
facility: Novartis Investigative Site
city: Weiden
country: Germany
facility: Novartis Investigative Site
city: Weinheim
country: Germany
facility: Novartis Investigative Site
city: Wetzlar
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Wilhelmshaven
country: Germany
facility: Novartis Investigative Site
city: Wolfsburg
country: Germany
facility: Novartis Investigative Site
city: Worms
country: Germany
facility: Novartis Investigative Site
city: Wuerselen
country: Germany
facility: Novartis Investigative Site
city: Wuerzburg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: