- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01250379
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Breast Cancer Progressing After First-Line Therapy With Avastin and Chemotherapy (TANIA)
12 stycznia 2016 zaktualizowane przez: Hoffmann-La Roche
A Phase III Randomized Study Evaluating the Efficacy and Safety of Continued and Re-induced Bevacizumab in Combination With Chemotherapy for Patients With Locally Recurrent or Metastatic Breast Cancer After First-line Chemotherapy and Bevacizumab Treatment
This randomized, open-label, parallel-group study will assess the efficacy and s afety of Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second- and third-line therapy in patients with locally recurrent o r metastatic breast cancer progressing after first-line therapy with Avastin and chemotherapy.
Patients will be randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks intravenously) plus standard chemotherapy or chemotherapy alone.
Anticipated time on study treatment is until third-line disease progression or unacceptable toxicity occurs.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
494
Faza
- Faza 3
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Buenos Aires, Argentyna, C1199ACI
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Buenos Aires, Argentyna, C1280AEB
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Buenos Aires, Argentyna, C1426ANZ
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San Miguel de Tucuman, Argentyna, T4000IAK
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Feldkirch, Austria, 6807
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Graz, Austria, 8036
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Innsbruck, Austria, 6020
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Krems, Austria, 3500
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Salzburg, Austria, 5020
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Steyr, Austria, 4400
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Villach, Austria, 9500
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Wien, Austria, 1090
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GO
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Goiania, GO, Brazylia, 74140-050
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RS
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Porto Alegre, RS, Brazylia, 90430-090
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SC
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Itajai, SC, Brazylia, 88301-220
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Split, Chorwacja, 21000
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Amiens, Francja, 80090
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Angers, Francja, 49933
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Besancon, Francja, 25030
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Bordeaux, Francja, 33000
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Boulogne Sur Mer, Francja, 62222
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Brest, Francja, 29609
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Caen, Francja, 14076
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Clermont Ferrand, Francja, 63011
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Dijon, Francja, 21079
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Grenoble, Francja, 38028
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Limoges, Francja, 87039
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Marseille, Francja, 13285
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Montpellier, Francja, 34298
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Nancy, Francja, 54100
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Nantes, Francja, 44202
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Paris, Francja, 75970
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Pierre Benite, Francja, 69495
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Reims CEDEX, Francja, 51056
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Rouen, Francja, 76038
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Saint Gregoire, Francja, 35768
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Saint Jean, Francja, 31240
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St Cloud, Francja, 92210
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St Priest En Jarez, Francja, 42271
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St Quentin, Francja, 02321
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Strasbourg, Francja, 67010
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Toulouse, Francja, 31076
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Athens, Grecja, 11528
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Ioannina, Grecja, 455 00
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Patras, Grecja, 265 00
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Thessaloniki, Grecja, 546 45
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Barcelona, Hiszpania, 08036
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Barcelona, Hiszpania, 08035
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Barcelona, Hiszpania, 08041
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Castellon, Hiszpania, 12002
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Cordoba, Hiszpania, 14004
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Leon, Hiszpania, 24071
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Lerida, Hiszpania, 25198
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Madrid, Hiszpania, 28040
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Madrid, Hiszpania, 28046
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Madrid, Hiszpania, 28034
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Madrid, Hiszpania, 28041
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Madrid, Hiszpania, 28007
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Madrid, Hiszpania, 28033
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Madrid, Hiszpania, 28223
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Malaga, Hiszpania, 29010
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Murcia, Hiszpania, 30008
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Sevilla, Hiszpania, 41014
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Valencia, Hiszpania, 46009
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Zaragoza, Hiszpania, 50009
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Cantabria
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Santander, Cantabria, Hiszpania, 39008
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Guipuzcoa
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San Sebastian, Guipuzcoa, Hiszpania, 20080
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Islas Baleares
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Palma De Mallorca, Islas Baleares, Hiszpania, 07014
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Tenerife
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La Laguna, Tenerife, Hiszpania, 38320
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Beer Sheva, Izrael, 8410101
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Jerusalem, Izrael, 91120
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Kfar-Saba, Izrael, 4428164
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Petach Tikva, Izrael, 4941492
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Ramat Gan, Izrael, 52620-00
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Rehovot, Izrael, 7610001
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Tel Aviv, Izrael
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Tel Aviv, Izrael, 6423906
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Amberg, Niemcy, 92224
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Aschaffenburg, Niemcy, 63739
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Berlin, Niemcy, 10367
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Berlin, Niemcy, 10719
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Bielefeld, Niemcy, 33604
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Chemnitz, Niemcy, 09116
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Dresden, Niemcy, 01307
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Düsseldorf, Niemcy, 40235
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Essen, Niemcy, 45122
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Essen, Niemcy, 45136
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Freiburg, Niemcy, 79110
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Göttingen, Niemcy, 37073
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Hamburg, Niemcy, 20249
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Hannover, Niemcy, 30177
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Heidelberg, Niemcy, 69120
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Heidelberg, Niemcy, 69115
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Karlsruhe, Niemcy, 76135
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Koeln, Niemcy, 50935
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Mannheim, Niemcy, 68161
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Muenster, Niemcy, 48149
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München, Niemcy, 80639
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Naunhof, Niemcy, 04683
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Neuss, Niemcy, 41462
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Nordhausen, Niemcy, 99734
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Osnabrueck, Niemcy, 49076
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Ravensburg, Niemcy, 88212
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Stade, Niemcy, 21680
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Stralsund, Niemcy, 18435
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Wiesbaden, Niemcy, 65199
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Aarau, Szwajcaria, 5000
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Chur, Szwajcaria, 7000
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Zürich, Szwajcaria, 8038
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Bardejov, Słowacja, 085 01
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Bratislava, Słowacja, 812 50
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Kosice, Słowacja, 04001
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Nove Zamky, Słowacja, 940 34
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Presov, Słowacja, 080 01
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Budapest, Węgry, 1122
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Budapest, Węgry, 1145
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Szeged, Węgry, 6720
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Calabria
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Cosenza, Calabria, Włochy, 87100
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Campania
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Benevento, Campania, Włochy, 82100
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Napoli, Campania, Włochy, 80131
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Emilia-Romagna
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Reggio Emilia, Emilia-Romagna, Włochy, 42100
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Friuli-Venezia Giulia
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Udine, Friuli-Venezia Giulia, Włochy, 33100
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Lazio
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Roma, Lazio, Włochy, 00168
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Lombardia
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Monza, Lombardia, Włochy, 20052
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Marche
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Macerata, Marche, Włochy, 62100
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Sardegna
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Cagliari, Sardegna, Włochy, 09121
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Sassari, Sardegna, Włochy, 07100
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Sicilia
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Catania, Sicilia, Włochy, 95100
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Toscana
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Firenze, Toscana, Włochy, 50134
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Pisa, Toscana, Włochy, 56100
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Pontedera, Toscana, Włochy, 56025
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Veneto
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Verona, Veneto, Włochy, 37126
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Kobieta
Opis
Inclusion Criteria:
- Female patients, >/= 18 years of age
- Histologically confirmed HER2-negative breast cancer
- Disease progression during or following first-line treatment with Avastin and chemotherapy for locally recurrent or metastatic breast cancer
- Avastin treatment in first-line setting must have been a minimum of 4 cycles (15 mg/kg) or 6 cycles (10 mg/kg) in combination with chemotherapy
- ECOG performance status 0-2
- At least 28 days since prior radiation therapy or surgery and recovery from treatment
Exclusion Criteria:
- Anti-angiogenic therapy or anti-vascular endothelial growth factors other than Avastin for first-line treatment
- Active malignancy other than superficial basal cell and superficial squamous cell carcinoma of the skin, or in situ carcinoma of the cervix or breast within the last 5 years
- Inadequate renal function
- Clinically relevant cardio-vascular disease
- Known CNS disease except for treated brain metastases
- Chronic daily treatment with high-dose aspirin (>325 mg/day) or clopidogrel (>75 mg/day)
- Pregnant or lactating women
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 2
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Standard chemotherapy (doublets not allowed)
10 mg/ kg iv every 2 weeks or 15 mg/kg iv every 3 weeks
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Aktywny komparator: 1
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Standard chemotherapy (doublets not allowed)
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
Ramy czasowe: Baseline (less than or equal to [≤] 28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
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Second-line PFS was defined as the time from randomization to progressive disease (PD) or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first.
For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions.
For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs.
Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
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Baseline (less than or equal to [≤] 28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
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Second-Line PFS
Ramy czasowe: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
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The median time, in months, from randomization to second-line PFS event.
For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions.
For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs.
Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
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Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
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Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 6
Ramy czasowe: Month 6
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Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first.
For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions.
For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs.
Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
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Month 6
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Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 12
Ramy czasowe: Month 12
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Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first.
For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions.
For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs.
Participants without secondline PD or death were censored at the date of last tumor assessment where non-progression was documented.
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Month 12
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Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 18
Ramy czasowe: Month 18
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Second-line PFS was defined as the time from randomization to PD or death due to any cause during their secondline of treatment with bevacizumab and/or chemotherapy, whichever occurred first.
For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions.
For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs.
Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
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Month 18
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Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 24
Ramy czasowe: Month 24
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Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first.
For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions.
For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs.
Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
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Month 24
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
Ramy czasowe: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
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The median time, in months, from randomization to second-line PFS event according to the following baseline risk factors: hormone receptor negative, HER2 negative (triple negative), hormone receptor positive/HER-2 negative (HR-pos/HER-neg), first-line PFS less than (<) 6 months, first-line PFS greater than or equal to (≥) 6 months, taxane chemotherapy (chemo), non-taxane chemo, vinorelbine chemo, LDH ≤ 1.5 upper limit of normal (ULN), LDH greater than (>) 1.5 ULN, < 65 years of age, ≥ 65 years of age, < 70 years of age, ≥ 70 years of age, < 3 metastatic organ sites, ≥ 3 metastatic organ sites, bevacizumab-free (B-free) interval ≤ 6 weeks, B-free > 6 weeks, disease-free (D-free) interval ≤ 24 months, D-free > 24 months, D-free ≤ 12 months, and D-free > 12 months.
Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
PD: defined in Outcome measure 1.
The 95% CI was estimated using Kaplan-Meier methodology.
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Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
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Percentage of Participants With a Second-Line Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 (Data Cutoff 20 December 2013)
Ramy czasowe: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
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BOR was defined as a confirmed CR or PR during second-line treatment.
For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD.
For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels.
The 95% Cl was determined using the Pearson-Clopper method.
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Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
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Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013)
Ramy czasowe: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
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For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started.
For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; stable disease was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs.
The 95% CI was determined using the Pearson-Clopper method.
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Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
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Duration of Second-Line Objective Response (Data Cutoff 20 December 2013)
Ramy czasowe: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
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The median time, in months, from the date of the first second-line documentation of CR or PR according to RECIST v1.1 to the date of the first second-line documentation of PD or death due to any cause.
For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started.
For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs.
Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free.
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Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
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Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013)
Ramy czasowe: Months 3, 6, and 9
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Duration of objective response was defined as the median time, in months, from the date of the first second-line documentation of CR or PR to the date of the first second-line documentation of PD or death due to any cause.
For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started.
For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs.
Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free.
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Months 3, 6, and 9
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Percentage of Participants With Third-Line PFS According to RECIST v1.1
Ramy czasowe: First dose of third-line treatment until PD or death due to any cause (assessed every 8-9 weeks, over a period of approximately 14 months)
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Third-line PFS was defined as the time from the date of first dose of third-line bevacizumab and/or chemotherapy to the date of third-line PD or death due to any cause.
For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions.
For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs.
Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
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First dose of third-line treatment until PD or death due to any cause (assessed every 8-9 weeks, over a period of approximately 14 months)
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Third-Line PFS
Ramy czasowe: First dose of third-line treatment until PD or death due to any cause (over a period of approximately 14 months)
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The median time, in months, from the first dose of third-line bevacizumab and/or chemotherapy to third-line PD or death due to any cause.
For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions.
For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs.
Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
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First dose of third-line treatment until PD or death due to any cause (over a period of approximately 14 months)
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Percentage of Participants With Second- and Third-Line PFS According to RECIST v1.1
Ramy czasowe: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years
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Second- and third-line PFS was defined as the time from the date randomization to the date of third-line PD or death due to any cause.
For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions.
For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs.
Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
|
Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years
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Second- and Third-Line PFS
Ramy czasowe: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years
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The median time, in months, from randomization to second-line and third-line PFS event.
For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions.
For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs.
Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
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Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years
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Percentage of Participants With Second- and Third-Line Tumor Progression
Ramy czasowe: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years
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Second- and third-line tumor progression was defined as occurrence of third-line PD according to RECIST v1.1 or death due to progression of disease.
For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions.
For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs.
Participants without third-line PD or death due to progression of disease were censored at the date of last tumor assessment where non-progression was documented.
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Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years
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Time to Second- and Third-Line Tumor Progression
Ramy czasowe: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years
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The median time, in months, from randomization to second- and third-line tumor progression.
Second- and third-line tumor progression was defined as third-line PD according to RECIST v1.1 or death due to progression of disease.
For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions.
For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs.
Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
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Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years
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Percentage of Participants Who Died
Ramy czasowe: Baseline until death (up to approximately 4 years)
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Percentage of participants who died due to any reason were reported.
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Baseline until death (up to approximately 4 years)
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Overall Survival (OS)
Ramy czasowe: Baseline until death (up to approximately 4 years)
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OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause.
Participants who had not died were censored at the date the patient was last known to be alive.
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Baseline until death (up to approximately 4 years)
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Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24
Ramy czasowe: Months 6, 12, 18, and 24
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OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause.
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Months 6, 12, 18, and 24
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Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Ramy czasowe: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
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The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility (M) ("no problems"="I have no problems in walking about" to "extreme problems"="I am confined to bed"), self-care (SC) ("no problems"="I have no problems with self-care" to "extreme problems"="I am unable to wash or dress myself"), usual activities (UA) ("no problems"="I have no problems performing my usual activities" to "extreme problems"="I am unable to perform my usual activities"), pain/discomfort (P/D) ("no problems"="I have no pain or discomfort" to "extreme problems"="I have extreme pain or discomfort"), and anxiety/depression (A/D) ("no problems"="I am not anxious or depressed" to "extreme problems"='I am extremely anxious or depressed").
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Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
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Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013)
Ramy czasowe: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
|
The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems).
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Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
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Change From Baseline in EQ-5D Index Scores (Data Cutoff 20 December 2013)
Ramy czasowe: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
|
The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems) where a negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.
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Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
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Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013)
Ramy czasowe: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
|
The participant was asked to rate their overall health on a 0-100 millimeter (mm) vertical scale, where the lowest endpoint=0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state).
The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters.
A higher value indicated a better health state.
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Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
|
Change From Baseline in VAS Scores (Data Cutoff 20 December 2013)
Ramy czasowe: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
|
The participant was asked to rate their overall health on a 0-100 mm vertical scale, where the lowest endpoint = 0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state).
The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters.
A negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.
|
Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Ramy czasowe: Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years)
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The Functional Assessment of Cancer Therapy-Breast (FACT-B) is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"), as follows: physical well-being (PWB) (7 items, total score 0-28), social/family well-being (SWB) (7 items, total score 0-28), emotional well-being (EWB) (6 items, total score 0-24), functional well-being (FWB) (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40).
The FACT-B Trial Outcomes Index (TOI) score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96).
The Functional Assessment of Cancer Therapy-General (FACT-G) total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108).
The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscales scores (total score 0-148).
In all cases a higher value indicated a better perceived quality of life.
|
Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years)
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Ramy czasowe: Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years)
|
The FACT-B is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"), as follows: PWB (7 items, total score 0-28), SWB (7 items, total score 0-28), EWB (6 items, total score 0-24), FWB (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40).
The FACT-B TOI score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96).
The FACT-G total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108).
The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscale scores (total score 0-148).
In all cases a higher value indicated a better perceived quality of life.
|
Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years)
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- Vrdoljak E, Marschner N, Zielinski C, Gligorov J, Cortes J, Puglisi F, Aapro M, Fallowfield L, Fontana A, Inbar M, Kahan Z, Welt A, Levy C, Brain E, Pivot X, Putzu C, Gonzalez Martin A, de Ducla S, Easton V, von Minckwitz G. Final results of the TANIA randomised phase III trial of bevacizumab after progression on first-line bevacizumab therapy for HER2-negative locally recurrent/metastatic breast cancer. Ann Oncol. 2016 Nov;27(11):2046-2052. doi: 10.1093/annonc/mdw316. Epub 2016 Aug 8.
- von Minckwitz G, Puglisi F, Cortes J, Vrdoljak E, Marschner N, Zielinski C, Villanueva C, Romieu G, Lang I, Ciruelos E, De Laurentiis M, Veyret C, de Ducla S, Freudensprung U, Srock S, Gligorov J. Bevacizumab plus chemotherapy versus chemotherapy alone as second-line treatment for patients with HER2-negative locally recurrent or metastatic breast cancer after first-line treatment with bevacizumab plus chemotherapy (TANIA): an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1269-78. doi: 10.1016/S1470-2045(14)70439-5. Epub 2014 Sep 28.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 lutego 2011
Zakończenie podstawowe (Rzeczywisty)
1 grudnia 2013
Ukończenie studiów (Rzeczywisty)
1 marca 2015
Daty rejestracji na studia
Pierwszy przesłany
25 listopada 2010
Pierwszy przesłany, który spełnia kryteria kontroli jakości
26 listopada 2010
Pierwszy wysłany (Oszacować)
30 listopada 2010
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
11 lutego 2016
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
12 stycznia 2016
Ostatnia weryfikacja
1 stycznia 2016
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- MO22998
- 2010-020998-16
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
produkt wyprodukowany i wyeksportowany z USA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Rak piersi
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Emory UniversityNational Cancer Institute (NCI)WycofanePrognostyczny rak piersi IV stopnia AJCC v8 | Przerzutowy nowotwór złośliwy w mózgu | Przerzutowy rak piersi | Anatomiczny IV stopień raka piersi American Joint Committee on Cancer (AJCC) v8
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Jonsson Comprehensive Cancer CenterZakończonyRak prostaty oporny na kastrację | Przerzutowy rak prostaty | Stadium IVA raka prostaty AJCC v8 | Rak prostaty w stadium IVB AJCC v8 | Rak prostaty w stadium IV American Joint Committee on Cancer (AJCC) v8Stany Zjednoczone
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Jonsson Comprehensive Cancer CenterZakończonyBiochemicznie nawracający rak prostaty | Przerzutowy rak prostaty | Nowotwór złośliwy z przerzutami w kości | Stadium IVA raka prostaty AJCC v8 | Rak prostaty w stadium IVB AJCC v8 | Rak prostaty w stadium IV American Joint Committee on Cancer (AJCC) v8Stany Zjednoczone
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Jonsson Comprehensive Cancer CenterEli Lilly and Company; Genentech, Inc.Aktywny, nie rekrutującyNiedrobnokomórkowy rak płuc z przerzutami | Oporny na leczenie niedrobnokomórkowy rak płuc | Rak płuca w stadium IV American Joint Committee on Cancer (AJCC) v8 | Rak płuc w stadium IVA AJCC v8 | Rak płuc w stadium IVB AJCC v8Stany Zjednoczone
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)ZakończonyGruczolakorak gruczołu krokowego III stopnia AJCC v7 | Gruczolakorak gruczołu krokowego II stopnia AJCC v7 | Stopień I gruczolakoraka gruczołu krokowego American Joint Committee on Cancer (AJCC) v7Stany Zjednoczone
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Jonsson Comprehensive Cancer CenterRekrutacyjnyRak prostaty oporny na kastrację | Przerzutowy rak prostaty | Stadium IVA raka prostaty AJCC v8 | Rak prostaty w stadium IVB AJCC v8 | Rak prostaty w stadium IV American Joint Committee on Cancer (AJCC) v8Stany Zjednoczone
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NRG OncologyNational Cancer Institute (NCI)Aktywny, nie rekrutującyAnatomiczny rak piersi IV stadium AJCC v8 | Prognostyczny rak piersi IV stopnia AJCC v8 | Nowotwór złośliwy z przerzutami w kości | Przerzutowy nowotwór złośliwy w węzłach chłonnych | Przerzutowy nowotwór złośliwy w wątrobie | Przerzutowy rak piersi | Przerzutowy nowotwór złośliwy w płucach | Nowotwór... i inne warunkiStany Zjednoczone, Kanada, Arabia Saudyjska, Republika Korei
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National Cancer Institute (NCI)ZakończonyOporny na leczenie złośliwy nowotwór lity | Nawracający złośliwy nowotwór lity | Przerzutowy złośliwy nowotwór lity | Nieoperacyjny lity nowotwór | Nawracający rak drobnokomórkowy płuca | Stopień IIIA Rak drobnokomórkowy płuca AJCC v7 | Etap IIIB Rak drobnokomórkowy płuca AJCC v7 | Rak drobnokomórkowy... i inne warunkiStany Zjednoczone
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Jonsson Comprehensive Cancer CenterBeiGene; Driven To CureWycofanePrzerzutowy rak nerkowokomórkowy | Rak nerkowokomórkowy IV stopnia AJCC v8 | Rak brodawkowaty nerki | Zbieranie raka przewodów | Nieoperacyjny rak nerki | Dziedziczna leiomyomatoza i rak nerkowokomórkowy | Jasnokomórkowy brodawkowaty nowotwór nerki | Dziedziczny rak brodawkowaty nerki | Niesklasyfikowany... i inne warunkiStany Zjednoczone
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Jonsson Comprehensive Cancer CenterAstraZenecaZakończonyRak płaskonabłonkowy jamy ustnej i gardła | Stopień kliniczny III zależny od HPV (p16-dodatni) rak jamy ustnej i gardła AJCC v8 | Stopień kliniczny II, w którym pośredniczy HPV (p16-dodatni) rak jamy ustnej i gardła AJCC v8 | Patologiczny etap I, w którym pośredniczy HPV (p16-dodatni) rak jamy... i inne warunkiStany Zjednoczone