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An Observational Study of Avastin (Bevacizumab) in Patients With HER2-metastatic or Locally Advanced Breast Cancer

18. Dezember 2015 aktualisiert von: Hoffmann-La Roche

An Ambispective, Non Interventional Study of 2 Cohorts (Triple Negative or HR+) of Patients With HER2- Metastatic or Locally Advanced Breast Cancer Treated With Avastin® (Bevacizumab) 1st Line for at Least 12 Months and Without Progression for at Least 12 Months.

This observational study will evaluate the safety and efficacy of triple negative or HR+ patients with HER2-metastatic or locally advanced breast cancer treated with Avastin (bevacizumab) as first line therapy for at least 12 months and without disease progression for at least 12 months. Data will be collected retrospectively (from the diagnosis to the inclusion in the study) and for 18 months from study start.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

228

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Frankreich
      • Aix En Provence, Frankreich, 13616
      • Aix En Provence, Frankreich, 13617
      • Ajaccio, Frankreich, 20176
      • Amiens, Frankreich, 80090
      • Antony, Frankreich, 92166
      • Arras, Frankreich, 62012
      • Bastia, Frankreich, 20200
      • Bayonne, Frankreich, 64100
      • Beauvais, Frankreich, 60021
      • Besancon, Frankreich, 25030
      • Beziers, Frankreich, 34535
      • Bobigny, Frankreich, 93009
      • Bordeaux, Frankreich, 33077
      • Bordeaux, Frankreich, 33030
      • Boulogne-billancourt, Frankreich, 92100
      • Bourg En Bresse, Frankreich, 01012
      • Brest, Frankreich, 29609
      • Caen, Frankreich, 14076
      • Chambery, Frankreich, 73011
      • Chateauroux, Frankreich, 36019
      • Cherbourg Octeville, Frankreich, 50102
      • Clermont Ferrand, Frankreich, 63050
      • Clermont Ferrand, Frankreich, 63011
      • Creteil, Frankreich, 94010
      • DAX, Frankreich, 40107
      • Dijon, Frankreich, 21079
      • Eaubonne, Frankreich, 95602
      • Evreux, Frankreich, 27025
      • Grenoble, Frankreich, 38000
      • La Chaussee St Victor, Frankreich, 41260
      • La Roche Sur Yon, Frankreich, 85925
      • La Tronche, Frankreich, 38700
      • Le Coudray, Frankreich, 28630
      • Lille, Frankreich, 59020
      • Lille, Frankreich, 59003
      • Limoges, Frankreich, 87042
      • Longjumeau, Frankreich, 91161
      • Lorient, Frankreich, 56322
      • Lormont, Frankreich, 33310
      • Lyon, Frankreich, 69373
      • Lyon, Frankreich, 69337
      • Marseille, Frankreich, 13285
      • Marseille, Frankreich, 13273
      • Marseille, Frankreich, 13004
      • Metz, Frankreich, 57045
      • Montivilliers, Frankreich, 76290
      • Mougins, Frankreich, 06250
      • Nancy, Frankreich, 54100
      • Narbonne, Frankreich, 11108
      • Nice, Frankreich, 06189
      • Osny, Frankreich, 95520
      • Paris, Frankreich, 75970
      • Paris, Frankreich, 75651
      • Paris, Frankreich, 75475
      • Paris, Frankreich, 75674
      • Paris, Frankreich, 75231
      • Paris, Frankreich, 75571
      • Paris, Frankreich, 75230
      • Paris, Frankreich, 75181
      • Perigueux, Frankreich, 24000
      • Reims, Frankreich, 51057
      • Romans Sur Isere, Frankreich, 26102
      • Rouen, Frankreich, 76000
      • Rouen, Frankreich, 76044
      • Saint Brieuc, Frankreich, 22015
      • Saint Gregoire, Frankreich, 35768
      • Saint Jean, Frankreich, 31240
      • Senlis, Frankreich, 60309
      • Soyaux, Frankreich, 16800
      • St Cloud, Frankreich, 92210
      • St Germain En Laye, Frankreich, 78105
      • St Michel, Frankreich, 16470
      • St Priest En Jarez, Frankreich, 42271
      • Strasbourg, Frankreich, 67010
      • Toulon, Frankreich, 83056
      • Toulouse, Frankreich
      • Toulouse, Frankreich, 31076
      • Troyes, Frankreich, 10003
      • Valence, Frankreich, 26953
      • Vannes, Frankreich, 56001
      • Verdun, Frankreich, 55107
      • Villejuif, Frankreich, 94805

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

Patients (triple negative or HR+) with HER2- metastatic or locally advanced breast cancer, treated with Avastin 1st line for at least 12 months and without progression for at least 12 months.

Beschreibung

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • HER2-metastatic breast cancer or locally advanced breast cancer
  • Patients with Avastin as first line therapy administered for at least 12 months
  • Patients without disease progression after the beginning of Avastin treatment for at least 12 months

Exclusion Criteria:

  • Patients not willing to give informed consent

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Kohorte

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants Who Were Disease-Free for at Least 12 Months After Initial Diagnosis
Zeitfenster: From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)
Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Percentage of participants who were disease-free for at least 12 months were reported.
From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants Who Were Disease-Free for at Least 24 Months After Initial Diagnosis
Zeitfenster: From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)
Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Percentage of participants who were disease-free for at least 24 months were reported.
From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)
Disease-Free Interval
Zeitfenster: From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)
Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Disease free interval was observed retrospectively and assessed at inclusion period or baseline (the time after the retrospective phase and at the start of prospective phase).
From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)
Mean Age at the Time of Local or Metastatic Progression
Zeitfenster: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Menopausal Status at the Time of Local or Metastatic Progression
Zeitfenster: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Menopausal status included premenopausal and menopausal. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at the Time of Local or Metastatic Progression
Zeitfenster: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on a 5 point scale: 0 equals (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, but ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50 percentage [%] of waking hours [h]), capable of all self care, but unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any selfcare, totally confined to bed or chair and 5=Dead. Only participants that reported in any of the specified scale was reported. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Mean Body Weight at the Time of Local or Metastatic Progression
Zeitfenster: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Mean Height at the Time of Local or Metastatic Progression
Zeitfenster: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Mean Body Mass Index (BMI) at the Time of Local or Metastatic Progression
Zeitfenster: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Breast Cancer (BRCA) Mutation at the Time of Local or Metastatic Progression
Zeitfenster: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression
Zeitfenster: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Metastatic diseases were identified at bone, lung, liver, central nervous system, soft tissue, lymph nodes, skin, pleura and other sites. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants Classified Based on Number of Metastatic Sites at the Time of Local or Metastatic Progression
Zeitfenster: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of participants that reported metastatic disease in less than or equal to (<=) 3 sites or greater than (>) 3 sites were assessed. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Visceral Involvement at the Time of Local or Metastatic Progression
Zeitfenster: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Estrogen Receptors (ER) at the Time of Local or Metastatic Progression
Zeitfenster: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Progesterone Receptors (PR) at the Time of Local or Metastatic Progression
Zeitfenster: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Cross Results for Both ER and PR at the Time of Local or Metastatic Progression
Zeitfenster: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With HR Status at the Time of Local or Metastatic Progression
Zeitfenster: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Negative HER2 Status at the Time of Local or Metastatic Progression
Zeitfenster: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Mitotic Index (MI) at the Time of Local or Metastatic Progression
Zeitfenster: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
MI is an indirect measure of cell proliferation that has been demonstrated to be a strong predictor of outcome for several human and canine cancers. Percentage of participants that reported a low, intermediate, high and unknown indices were included. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Ki67 (MiB1) at the Time of Local or Metastatic Progression
Zeitfenster: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
The Ki67 (MiB1) a prognostic marker, is used to evaluate the proliferative activity of breast cancer. Percentage of participants with < or >=10% and unknown were reported. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Previous and Concurrent Disease at the Time of Local or Metastatic Progression
Zeitfenster: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants Who Received First-Line Endocrine Therapy at the Time of Local or Metastatic Progression
Zeitfenster: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR)
Zeitfenster: From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline)
Objective tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR was defined as the disappearance of all target and non-target lesions, and confirmed PR was defined as at least at 30% decrease in the sum of the longest diameters of target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.
From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline)
Percentage of Participants With Disease Progression or Death
Zeitfenster: From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline)
Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death"). PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment.
From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline)
Progression-Free Survival
Zeitfenster: From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline)
Progression-free survival was defined as the time from first dose of bevacizumab to documented PD or death from any cause, whichever occurred first. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.
From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline)
Time to Progression
Zeitfenster: From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline)
Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Participants who withdrew from the study early for insufficient therapeutic response without tumor assessment for PD were also included within the definition of PD. Time to progression was defined as the time from treatment start to PD. Participants who did not experience PD were censored from the last tumor assessment. Time to progression was estimated using Kaplan-Meier and expressed in months. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.
From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline)
Percentage of Participants With Death
Zeitfenster: From the first administration of bevacizumab to death from any cause (up to a maximum of 60.8 months including retrospective and prospective treatment)
Overall survival (OS) was defined as the time between the first administration of bevacizumab and death from any cause and participants still alive at the end of the study were censored at the last consultation or last contact date.
From the first administration of bevacizumab to death from any cause (up to a maximum of 60.8 months including retrospective and prospective treatment)
Overall Survival (OS)
Zeitfenster: From the first administration of bevacizumab to death from any cause (up to a maximum of 60.8 months including retrospective and prospective treatment)
OS was defined as the time between the first administration of bevacizumab and death from any cause and participants still alive at the end of the study were censored at the last consultation or last contact date.
From the first administration of bevacizumab to death from any cause (up to a maximum of 60.8 months including retrospective and prospective treatment)
Duration of Bevacizumab as First Line Treatment
Zeitfenster: From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
Percentage of Participants With Temporary Discontinuation
Zeitfenster: From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
Percentage of Participants With Reasons for Temporary Discontinuation
Zeitfenster: From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
Percentage of Participants With Definitive Discontinuation
Zeitfenster: From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
Percentage of Participants With Reasons for Definitive Discontinuation
Zeitfenster: From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
Percentage of Participants Who Maintained Bevacizumab Beyond the First Progressive Disease
Zeitfenster: From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
Percentage of Participants Who Received Induction Therapy in Combination With Bevacizumab
Zeitfenster: From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hoffmann-La Roche

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2011

Primärer Abschluss (Tatsächlich)

1. November 2013

Studienabschluss (Tatsächlich)

1. November 2013

Studienanmeldedaten

Zuerst eingereicht

24. Oktober 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Oktober 2011

Zuerst gepostet (Schätzen)

27. Oktober 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

26. Januar 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. Dezember 2015

Zuletzt verifiziert

1. Dezember 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ML27760

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