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Can ribociclib keep breast cancer from coming back? new study tracks Real-World results

NCT ID NCT06830720

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 4 times

Summary

This study follows about 3,250 people with HR+/HER2- early breast cancer who are at high risk of recurrence. Participants take ribociclib (Kisqali) plus an aromatase inhibitor as part of their routine care. Researchers will track how well the treatment works in real life, its side effects, and how it affects quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ribociclib (Kisqali) plus an aromatase inhibitor, with or without LHRH therapy
What this could lead to
If successful, this study could confirm that ribociclib combination therapy works well in everyday practice to reduce the risk of breast cancer returning.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by patient differences. It also does not test a new treatment, only monitors existing ones.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 3,250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult female and male patients with an indication for adjuvant treatment with ribociclib + AI ± LHRH (or abemaciclib + ET ± LHRH for the abemaciclib cohort) in HR+/HER2- eBC at high risk of recurrence as described in the current effective summary of product characteristics enrolled from specialized centers, hospitals and outpatient centers.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histological diagnosis of HR+/HER2- early breast cancer with curative intent * Patients must have an indication for a treatment with ribociclib + AI ± LHRH as described in the current SmPC/"Fachinformation" of ribociclib (to be included into the cohorts of ribociclib + AI ± LHRH and ET mono ± LHRH) or abemaciclib + ET ± LHRH as described in the current SmPC/"Fachinformation" of abemaciclib (to be included into the abemaciclib + ET ± LHRH cohort) in the adjuvant setting * Before enrollment the treating physician has made the decision in accordance with the patient to treat the patient with either * ribociclib + AI ± LHRH, or * ET mono ± LHRH, or * abemaciclib + ET ± LHRH and baseline is no longer than 2 weeks (14 days) prior to written informed consent for this study. Baseline = for ribociclib + AI ± LHRH cohort: date of therapy start; for abemaciclib + ET ± LHRH cohort: date of therapy start; for ET mono ± LHRH cohort: within 4 weeks after therapy start or within 4 weeks after last non-endocrine based therapy, whichever is last. * ≥18 years of age * Written informed consent Exclusion Criteria: \- Patient is simultaneously participating in any investigational trial or simultaneously participating in another Novartis-sponsored non-interventional study with ribociclib.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Breast neoplasms are added.

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Conditions

The condition(s) this trial relates to.

breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    285 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Novartis Investigative Site

    RECRUITING

    Wiener Neustadt, Lower Austria, 2700, Austria

  • Novartis Investigative Site

    RECRUITING

    Innsbruck, Tyrol, 6020, Austria

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    Linz, Upper Austria, 4010, Austria

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    Graz, 8036, Austria

  • Novartis Investigative Site

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    Klagenfurt, 9020, Austria

  • Novartis Investigative Site

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    Leoben, 8700, Austria

  • Novartis Investigative Site

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    Schwaz, 6130, Austria

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    Steyr, 4400, Austria

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    Vienna, 1090, Austria

  • Novartis Investigative Site

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    Vienna, 1130, Austria

  • Novartis Investigative Site

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    Vienna, 1140, Austria

  • Novartis Investigative Site

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    Vienna, 1160, Austria

  • Novartis Investigative Site

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    Baden-Baden, Baden-Wurttemberg, 76532, Germany

  • Novartis Investigative Site

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    Filderstadt, Baden-Wurttemberg, 70794, Germany

  • Novartis Investigative Site

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    Freudenstadt, Baden-Wurttemberg, 72250, Germany

  • Novartis Investigative Site

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    Heidelberg, Baden-Wurttemberg, 69115, Germany

  • Novartis Investigative Site

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    Heidenheim, Baden-Wurttemberg, 89522, Germany

  • Novartis Investigative Site

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    Konstanz, Baden-Wurttemberg, 78464, Germany

  • Novartis Investigative Site

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    Mannheim, Baden-Wurttemberg, 68161, Germany

  • Novartis Investigative Site

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    Mannheim, Baden-Wurttemberg, 68165, Germany

  • Novartis Investigative Site

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    Nürtingen, Baden-Wurttemberg, 72622, Germany

  • Novartis Investigative Site

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    Ostfildern, Baden-Wurttemberg, 73760, Germany

  • Novartis Investigative Site

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    Pforzheim, Baden-Wurttemberg, 75179, Germany

  • Novartis Investigative Site

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    Ravensburg, Baden-Wurttemberg, 88212, Germany

  • Novartis Investigative Site

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    Reutlingen, Baden-Wurttemberg, 72764, Germany

  • Novartis Investigative Site

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    Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany

  • Novartis Investigative Site

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    Villingen-Schwenningen, Baden-Wurttemberg, 78052, Germany

  • Novartis Investigative Site

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    Winnenden, Baden-Wurttemberg, 71364, Germany

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    Altötting, Bavaria, 84503, Germany

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    Ansbach, Bavaria, 91522, Germany

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    Augsburg, Bavaria, 86157, Germany

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    Bamberg, Bavaria, 96049, Germany

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    Bayreuth, Bavaria, 95445, Germany

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    Dillingen an der Donau, Bavaria, 89407, Germany

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    Donauwörth, Bavaria, 86609, Germany

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    Ebersberg, Bavaria, 85560, Germany

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    Erlangen, Bavaria, 91054, Germany

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    Fürth, Bavaria, 90766, Germany

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    Herrsching am Ammersee, Bavaria, 82211, Germany

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    Kempten (Allgäu), Bavaria, 87439, Germany

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    Kronach, Bavaria, 96317, Germany

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    Landsberg am Lech, Bavaria, 86899, Germany

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    Munich, Bavaria, 80637, Germany

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    Munich, Bavaria, 81241, Germany

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    Munich, Bavaria, 81377, Germany

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    Munich, Bavaria, 81925, Germany

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    Neumarkt in der Oberpfalz, Bavaria, 92318, Germany

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    Prien am Chiemsee, Bavaria, 83209, Germany

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    Regensburg, Bavaria, 93053, Germany

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    Rosenheim, Bavaria, 83022, Germany

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    Traunstein, Bavaria, 83278, Germany

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    Ulm, Bavaria, 89073, Germany

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    Waldmuenchen, Bavaria, 93449, Germany

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    Weiden in Der Oberpfalz, Bavaria, 92637, Germany

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    Weilheim, Bavaria, 82362, Germany

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    Würzburg, Bavaria, 97070, Germany

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    Brandenburg an der Havel, Brandenburg, 14770, Germany

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    Cottbus, Brandenburg, 03048, Germany

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    Königs Wusterhausen, Brandenburg, 15711, Germany

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    Hamburg, Free and Hanseatic City of Hamburg, 22291, Germany

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    Hamburg, Free and Hanseatic City of Hamburg, 22457, Germany

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    Bremen, Free Hanseatic City of Bremen, 28209, Germany

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    Bremen, Free Hanseatic City of Bremen, 28239, Germany

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    Bremerhaven, Free Hanseatic City of Bremen, 27576, Germany

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    Bad Homburg, Hesse, 61352, Germany

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    Bad Nauheim, Hesse, 61231, Germany

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    Frankfurt am Main, Hesse, 60398, Germany

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    Frankfurt am Main, Hesse, 60431, Germany

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    Frankfurt am Main, Hesse, 65929, Germany

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    Langen, Hesse, 63225, Germany

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    Marburg, Hesse, 35037, Germany

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    Marburg, Hesse, 35043, Germany

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    Wiesbaden, Hesse, 65189, Germany

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    Wiesbaden, Hesse, 65199, Germany

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    Braunschweig, Lower Saxony, 38100, Germany

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    Buchholz Nordheide, Lower Saxony, 21244, Germany

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    Georgsmarienhütte, Lower Saxony, 49124, Germany

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    Göttingen, Lower Saxony, 37073, Germany

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    Hildesheim, Lower Saxony, 31134, Germany

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    Ilsede, Lower Saxony, 31241, Germany

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    Lingen, Lower Saxony, 49808, Germany

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    Osnabrück, Lower Saxony, 49076, Germany

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    Rotenburg (Wümme), Lower Saxony, 27356, Germany

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    RECRUITING

    Twistringen, Lower Saxony, 27239, Germany

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    Westerstede, Lower Saxony, 26655, Germany

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    RECRUITING

    Winsen, Lower Saxony, 21423, Germany

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    RECRUITING

    Wolfenbüttel, Lower Saxony, 38304, Germany

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    RECRUITING

    Wunstorf, Lower Saxony, 31515, Germany

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    RECRUITING

    Rostock, Mecklenburg-Vorpommern, 18057, Germany

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    RECRUITING

    Aachen, North Rhine-Westphalia, 52066, Germany

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    RECRUITING

    Bergisch Gladbach, North Rhine-Westphalia, 51465, Germany

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    RECRUITING

    Bielefeld, North Rhine-Westphalia, 33604, Germany

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    Bielefeld, North Rhine-Westphalia, 33615, Germany

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    RECRUITING

    Bochum, North Rhine-Westphalia, 44791, Germany

  • Novartis Investigative Site

    RECRUITING

    Bonn, North Rhine-Westphalia, 53113, Germany

  • Novartis Investigative Site

    RECRUITING

    Bonn, North Rhine-Westphalia, 53177, Germany

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    RECRUITING

    Cologne, North Rhine-Westphalia, 50679, Germany

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    Cologne, North Rhine-Westphalia, 50937, Germany

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    Dortmund, North Rhine-Westphalia, 44137, Germany

  • Novartis Investigative Site

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    Düsseldorf, North Rhine-Westphalia, 40217, Germany

  • Novartis Investigative Site

    RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • Novartis Investigative Site

    RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40625, Germany

  • Novartis Investigative Site

    RECRUITING

    Hagen, North Rhine-Westphalia, 58089, Germany

  • Novartis Investigative Site

    RECRUITING

    Mönchengladbach, North Rhine-Westphalia, 41061, Germany

  • Novartis Investigative Site

    RECRUITING

    Olpe, North Rhine-Westphalia, 57462, Germany

  • Novartis Investigative Site

    RECRUITING

    Paderborn, North Rhine-Westphalia, 33098, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Remscheid, North Rhine-Westphalia, 42853, Germany

  • Novartis Investigative Site

    RECRUITING

    Remscheid, North Rhine-Westphalia, 42859, Germany

  • Novartis Investigative Site

    RECRUITING

    Schwerte, North Rhine-Westphalia, 58239, Germany

  • Novartis Investigative Site

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    Siegen, North Rhine-Westphalia, 57072, Germany

  • Novartis Investigative Site

    RECRUITING

    Troisdorf, North Rhine-Westphalia, 53840, Germany

  • Novartis Investigative Site

    RECRUITING

    Velbert, North Rhine-Westphalia, 42551, Germany

  • Novartis Investigative Site

    RECRUITING

    Mayen, Rhineland-Palatinate, 56727, Germany

  • Novartis Investigative Site

    RECRUITING

    Neustadt an der Weinstraße, Rhineland-Palatinate, 67434, Germany

  • Novartis Investigative Site

    RECRUITING

    Speyer, Rhineland-Palatinate, 67346, Germany

  • Novartis Investigative Site

    RECRUITING

    Lebach, Saarland, 66822, Germany

  • Novartis Investigative Site

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    Borna, Saxony, 04552, Germany

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    RECRUITING

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    RECRUITING

    Leipzig, Saxony, 04103, Germany

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    RECRUITING

    Neustadt in Sachsen, Saxony, 01844, Germany

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    RECRUITING

    Plauen, Saxony, 08525, Germany

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    Radebeul, Saxony, 01445, Germany

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    Rodewisch, Saxony, 08228, Germany

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    Scheibenberg, Saxony, 09481, Germany

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    Schkeuditz, Saxony, 04435, Germany

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    Zittau, Saxony, 02763, Germany

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    Halle, Saxony-Anhalt, 06110, Germany

  • Novartis Investigative Site

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    Halle, Saxony-Anhalt, 06120, Germany

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    Hansestadt Salzwedel, Saxony-Anhalt, 29410, Germany

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    Magdeburg, Saxony-Anhalt, 39108, Germany

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    Magdeburg, Saxony-Anhalt, 39130, Germany

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    Stendal, Saxony-Anhalt, 39576, Germany

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    Flensburg, Schleswig-Holstein, 24939, Germany

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    Lübeck, Schleswig-Holstein, 23563, Germany

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    Rendsburg, Schleswig-Holstein, 24768, Germany

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    Berlin, State of Berlin, 13156, Germany

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    Jena, Thuringia, 07740, Germany

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    Mühlhausen, Thuringia, 99974, Germany

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    Nordhausen, Thuringia, 99734, Germany

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    Saalfeld, Thuringia, 07318, Germany

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    Aachen, 52074, Germany

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    Amberg, 92224, Germany

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    Apolda, 99510, Germany

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    Arnsberg, 59759, Germany

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    Augsburg, 86150, Germany

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    Bad Friedrichshall, 74177, Germany

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    Bad Kreuznach, 55543, Germany

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    Bad Langensalza, 99947, Germany

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    Bad Mergentheim, 97980, Germany

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    Bad Reichenhall, 83435, Germany

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    Bad Saarow, 15526, Germany

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    Bad Soden, 65812, Germany

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    Balingen, 72336, Germany

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    Bautzen, 02625, Germany

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    Bayreuth, 95445, Germany

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    Berlin, 10367, Germany

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    Berlin, 10715, Germany

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    Berlin, 12552, Germany

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    Berlin, 13589, Germany

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    Berlin, 14169, Germany

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    Berlin, 14195, Germany

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    Biberach, 88400, Germany

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    Bochum, 44787, Germany

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    Bonn, 53105, Germany

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    Bonn, 53113, Germany

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    Bonn, 53123, Germany

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    Bottrop, 46236, Germany

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    Böblingen, 71032, Germany

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    Brandenburg, 14770, Germany

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    Bremen, 28205, Germany

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    Bremerhaven, 27574, Germany

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    Bruchsal, 76646, Germany

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    Celle, 29223, Germany

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    Chemnitz, 09113, Germany

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    Chemnitz, 09117, Germany

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    Coburg, 96450, Germany

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    Cologne, 50935, Germany

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    Dachau, 85221, Germany

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    Dessau, 06847, Germany

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    Dorfen, 84405, Germany

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    Dresden, 01127, Germany

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    Dresden, 01307, Germany

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    Duisburg, 47053, Germany

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    Düsseldorf, 40235, Germany

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    Eggenfelden, 84307, Germany

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    Ehingen, 89584, Germany

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    Ehrenfriedersdorf, 09427, Germany

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    Eisenach, 99817, Germany

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    Erding, 85435, Germany

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    Erfurt, 99084, Germany

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    Erfurt, 99085, Germany

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    Eschweiler, 52249, Germany

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    Essen, 45136, Germany

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    Essen, 45147, Germany

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    Esslingen am Neckar, 73730, Germany

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    Eutin, 23701, Germany

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    Freiburg im Breisgau, 79110, Germany

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    Friedrichshafen, 88045, Germany

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    Friedrichshafen, 88048, Germany

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    Fürstenwalde, 15517, Germany

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    Gengenbach, 77723, Germany

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    Gera, 07548, Germany

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    Gerlingen, 70839, Germany

  • Novartis Investigative Site

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    Goslar, 38642, Germany

  • Novartis Investigative Site

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    Göttingen, 37075, Germany

  • Novartis Investigative Site

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    Greifswald, 17489, Germany

  • Novartis Investigative Site

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    Gummersbach, 51643, Germany

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    Günzburg, 89312, Germany

  • Novartis Investigative Site

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    Hagen, 58095, Germany

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    Haldensleben I, 39340, Germany

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    Hamburg, 20259, Germany

  • Novartis Investigative Site

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    Hamburg, 20357, Germany

  • Novartis Investigative Site

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    Hamburg, 21073, Germany

  • Novartis Investigative Site

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    Hanover, 30159, Germany

  • Novartis Investigative Site

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    Hanover, 30177, Germany

  • Novartis Investigative Site

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    Hanover, 30625, Germany

  • Novartis Investigative Site

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    Heide, 25746, Germany

  • Novartis Investigative Site

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    Heidelberg, 69120, Germany

  • Novartis Investigative Site

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    Heilbronn, 74078, Germany

  • Novartis Investigative Site

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    Hennigsdorf, 16761, Germany

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    Herdecke, 58313, Germany

  • Novartis Investigative Site

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    Homburg, 66421, Germany

  • Novartis Investigative Site

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    Itzehoe, 25524, Germany

  • Novartis Investigative Site

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    Jena, 07747, Germany

  • Novartis Investigative Site

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    Kaiserslautern, 67655, Germany

  • Novartis Investigative Site

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    Karlsruhe, 76133, Germany

  • Novartis Investigative Site

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    Karlsruhe, 76135, Germany

  • Novartis Investigative Site

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    Kiel, 24103, Germany

  • Novartis Investigative Site

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    Krefeld, 47805, Germany

  • Novartis Investigative Site

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    Kulmbach, 95326, Germany

  • Novartis Investigative Site

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    Leer, 26789, Germany

  • Novartis Investigative Site

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    Leipzig, 04277, Germany

  • Novartis Investigative Site

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    Loerrach, 79539, Germany

  • Novartis Investigative Site

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    Lübeck, 23538, Germany

  • Novartis Investigative Site

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    Mainz, 55131, Germany

  • Novartis Investigative Site

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    Marktredwitz, 95615, Germany

  • Novartis Investigative Site

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    Memmingen, 87700, Germany

  • Novartis Investigative Site

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    Moers, 47441, Germany

  • Novartis Investigative Site

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    Mutlangen, 73557, Germany

  • Novartis Investigative Site

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    Münster, 48145, Germany

  • Novartis Investigative Site

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    Münster, 48149, Germany

  • Novartis Investigative Site

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    Naunhof, 04683, Germany

  • Novartis Investigative Site

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    Neubrandenburg, 17036, Germany

  • Novartis Investigative Site

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    Neumünster, 24534, Germany

  • Novartis Investigative Site

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    Neuruppin, 16816, Germany

  • Novartis Investigative Site

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    Neuss, 41462, Germany

  • Novartis Investigative Site

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    Nuremberg, 90403, Germany

  • Novartis Investigative Site

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    Nuremberg, 90419, Germany

  • Novartis Investigative Site

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    Offenburg, 77654, Germany

  • Novartis Investigative Site

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    Oldenburg, 26121, Germany

  • Novartis Investigative Site

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    Passau, 94036, Germany

  • Novartis Investigative Site

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    Potsdam, 14467, Germany

  • Novartis Investigative Site

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    Potsdam, 14482, Germany

  • Novartis Investigative Site

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    Recklinghausen, 45657, Germany

  • Novartis Investigative Site

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    Regensburg, 93053, Germany

  • Novartis Investigative Site

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    Rheine, 48431, Germany

  • Novartis Investigative Site

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    Rüsselsheim am Main, 65428, Germany

  • Novartis Investigative Site

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    Saarlouis, 66740, Germany

  • Novartis Investigative Site

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    Schorndorf, 73614, Germany

  • Novartis Investigative Site

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    Schweinfurt, 97422, Germany

  • Novartis Investigative Site

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    Siegen, 57074, Germany

  • Novartis Investigative Site

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    Sigmaringen, 72488, Germany

  • Novartis Investigative Site

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    Singen, 78224, Germany

  • Novartis Investigative Site

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    Sinsheim, 74889, Germany

  • Novartis Investigative Site

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    Soest, 59494, Germany

  • Novartis Investigative Site

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    Stendal, 39576, Germany

  • Novartis Investigative Site

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    Stralsund, 18439, Germany

  • Novartis Investigative Site

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    Stuttgart, 70174, Germany

  • Novartis Investigative Site

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    Stuttgart, 70176, Germany

  • Novartis Investigative Site

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    Stuttgart, 70199, Germany

  • Novartis Investigative Site

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    Suhl, 98527, Germany

  • Novartis Investigative Site

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    Torgau, 04860, Germany

  • Novartis Investigative Site

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    Traunstein, 83278, Germany

  • Novartis Investigative Site

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    Trier, 54290, Germany

  • Novartis Investigative Site

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    Tübingen, 72076, Germany

  • Novartis Investigative Site

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    Ulm, 89081, Germany

  • Novartis Investigative Site

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    Waldkirchen, 94065, Germany

  • Novartis Investigative Site

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    Waldsassen, 95652, Germany

  • Novartis Investigative Site

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    Walsrode, 29664, Germany

  • Novartis Investigative Site

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    Weinheim, 69469, Germany

  • Novartis Investigative Site

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    Werdau, 08412, Germany

  • Novartis Investigative Site

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    Wernigerode, 38855, Germany

  • Novartis Investigative Site

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    Wesel, 46485, Germany

  • Novartis Investigative Site

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    Wetzlar, 35578, Germany

  • Novartis Investigative Site

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    Witten, 58452, Germany

  • Novartis Investigative Site

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    Worms, 67550, Germany

  • Novartis Investigative Site

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    Würzburg, 97080, Germany

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