Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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

18. prosince 2015 aktualizováno: 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.

Přehled studie

Postavení

Postavení

Označuje aktuální stav náboru nebo stav rozšířeného přístupu.
Dokončeno

Podmínky

Podmínky

Nemoc, porucha, syndrom, nemoc nebo zranění, které je studováno. Na webu ClinicalTrials.gov mohou podmínky zahrnovat i další problémy související se zdravím, jako je délka života, kvalita života a zdravotní rizika.

Typ studie

Typ studie

Popisuje povahu klinické studie. Typy studií zahrnují intervenční studie (také nazývané klinické studie), observační studie (včetně registrů pacientů) a rozšířený přístup.
Pozorovací

Zápis (Aktuální)

Zápis

Počet účastníků klinické studie. „Očekávaný“ zápis je cílový počet účastníků, které výzkumníci pro studii potřebují.
228

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Kritéria způsobilosti

Klíčové požadavky, které musí lidé, kteří se chtějí zúčastnit klinické studie, splňovat nebo vlastnosti, které musí mít. Kritéria způsobilosti se skládají jak z kritérií pro zařazení (která jsou vyžadována pro účast osoby ve studii), tak z kritérií vyloučení (která brání osobě v účasti). Typy kritérií způsobilosti zahrnují, zda studie přijímá zdravé dobrovolníky, má požadavky na věk nebo věkovou skupinu nebo je omezena pohlavím.

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Ukázka pravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta

Skupina / kohorta

Skupina nebo podskupina účastníků pozorovací studie, která je hodnocena z hlediska biomedicínských nebo zdravotních výsledků.
Kohorta

Co je měření studie?

Primární výstupní opatření

Primární výstupní opatření

V protokolu klinické studie je plánovaná výsledná míra, která je nejdůležitější pro hodnocení účinku intervence/léčby. Většina klinických studií má jedno primární měřítko výsledku, ale některé mají více než jedno.
Měření výsledku
Popis opatření
Časové okno
Percentage of Participants Who Were Disease-Free for at Least 12 Months After Initial Diagnosis
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)

Sekundární výstupní opatření

Sekundární výstupní opatření

V protokolu klinické studie jde o plánované měřítko výsledku, které není tak důležité jako primární měřítko výsledku pro hodnocení účinku intervence, ale je stále zajímavé. Většina klinických studií má více než jedno sekundární měřítko výsledku.
Měření výsledku
Popis opatření
Časové okno
Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Sponzor

Organizace nebo osoba, která iniciuje studii a která má autoritu a kontrolu nad studií.
Hoffmann-La Roche

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

Začátek studia

Skutečné datum, kdy byl první účastník zařazen do klinické studie. „Očekávané“ datum zahájení studie je datum, o kterém si vědci myslí, že bude datem zahájení studie.
1. září 2011

Primární dokončení (Aktuální)

Primární dokončení

Datum, kdy byl poslední účastník klinické studie vyšetřen nebo obdržel intervenci ke sběru konečných dat pro primární měření výsledku. Zda byla klinická studie ukončena podle protokolu nebo byla ukončena, toto datum neovlivňuje. U klinických studií s více než jedním primárním výstupním měřením s různými daty dokončení se tento termín vztahuje k datu, kdy je dokončen sběr dat pro všechna primární výsledná měření. „Očekávané“ datum primárního dokončení je datum, o kterém si vědci myslí, že bude primárním datem dokončení studie.
1. listopadu 2013

Dokončení studie (Aktuální)

Dokončení studie

Datum, kdy byl poslední účastník klinické studie vyšetřen nebo dostal intervenci/léčbu za účelem shromáždění konečných dat pro měření primárního výsledku, sekundárního měření výsledku a nežádoucí příhody (tj. poslední návštěva posledního účastníka). „Očekávané“ datum dokončení studie je datum, o kterém si vědci myslí, že bude datem dokončení studie.
1. listopadu 2013

Termíny zápisu do studia

První předloženo

První předloženo

Datum, kdy zadavatel studie nebo zkoušející poprvé předložil záznam studie na ClinicalTrials.gov. Mezi prvním odeslaným datem a dostupností záznamu na ClinicalTrials.gov (první zveřejněné datum) je obvykle několik dní.
24. října 2011

První předloženo, které splnilo kritéria kontroly kvality

První předloženo, které splnilo kritéria kontroly kvality

Datum, kdy zadavatel studie nebo zkoušející poprvé předloží záznam studie, který je v souladu s kritérii kontroly kvality (QC) Národní lékařské knihovny (NLM). Sponzor nebo zkoušející může potřebovat revidovat a předložit záznam studie jednou nebo vícekrát, než budou splněna kritéria kontroly kontroly kvality NLM. Je odpovědností sponzora nebo zkoušejícího zajistit, aby byl záznam studie v souladu s kritérii kontroly kontroly kvality NLM.
26. října 2011

První zveřejněno (Odhad)

První zveřejněno

Datum, kdy byl záznam studie poprvé k dispozici na webu ClinicalTrials.gov poté, co byla dokončena kontrola kontroly kvality (QC) National Library of Medicine (NLM). Mezi datem, kdy zadavatel studie nebo zkoušející předložil záznam studie, a prvním zveřejněným datem je typicky několik dní zpoždění.
27. října 2011

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

Poslední zveřejněná aktualizace

Nejnovější datum, kdy byly změny záznamu studie zpřístupněny na ClinicalTrials.gov. Mezi okamžikem, kdy byly změny odeslány na ClinicalTrials.gov sponzorem nebo zkoušejícím studie (datum poslední předložení aktualizace), a datem zveřejnění poslední aktualizace může nastat zpoždění.
26. ledna 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

Nejnovější datum, kdy zadavatel studie nebo zkoušející předložil změny záznamu studie, které jsou v souladu s kritérii kontroly kvality (QC) National Library of Medicine (NLM). Je odpovědností sponzora nebo zkoušejícího zajistit, aby byl záznam studie v souladu s kritérii kontroly kontroly kvality NLM.
18. prosince 2015

Naposledy ověřeno

Naposledy ověřeno

Nejnovější datum, kdy zadavatel studie nebo zkoušející potvrdil informace o klinické studii na webu ClinicalTrials.gov jako přesné a aktuální. Pokud jde o studii s náborovým statusem náboru; ještě nenabírá nábor; nebo aktivní, nebyl nábor potvrzen během posledních 2 let, status náboru studie je uveden jako neznámý.
1. prosince 2015

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

Další identifikační čísla studie

Identifikátory nebo ID čísla jiná než číslo NCT, které klinické studii přiděluje zadavatel studie, financující subjekty nebo jiní. Tato čísla mohou zahrnovat jedinečné identifikátory z jiných registrů studií a čísla grantů National Institutes of Health.
  • ML27760

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Nastavení souborů cookie

Používáme cookies, abychom zajistili, že vám poskytneme nejlepší zážitek z našich webových stránek. Pro více informací si pečlivě přečtěte naše Zásady ochrany osobních údajů a cookies. ...>>>Svou preference můžete kdykoli změnit nebo svůj souhlas odvolat odstraněním cookies z vašeho webu nebo počítače, jak je popsáno v zásadách. Přijměte to a vyberte své předvolby zaškrtnutím příslušných polí v části „Správa nastavení“ níže. Než budete pokračovat v používání jakékoli části tohoto webu, pozorně si prosím přečtěte naše Podmínky služby.
«Spravovat nastavení