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A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.

21. august 2015 opdateret af: Hoffmann-La Roche

A Randomized, Open-label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Herceptin/Docetaxel and Herceptin/Docetaxel Alone on Progression-free Survival in Patients With HER2 Positive Locally Recurrent or Metastatic Breast Cancer.

This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/docetaxel, versus Herceptin/docetaxel alone, in patients with HER2 positive locally recurrent or metastatic breast cancer who have not received prior chemotherapy for their metastatic disease. Patients will be randomized 1:1 to receive either Avastin (15mg/kg iv q3weeks) + Herceptin (8mg/kg iv loading dose and 6mg/kg iv q3weeks maintenance) + docetaxel (100mg/m2 iv q3weeks) or Herceptin + docetaxel alone. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

424

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, 1417
      • Cordoba, Argentina, 5004
      • La Plata, Argentina, B1902CMK
      • Mar del Plata, Argentina, 7600
      • Mendoza, Argentina, 5500
      • Salta, Argentina, 4400
      • San Martin, Argentina, 1650
      • Santa Fe, Argentina, 2000
      • Santa Fe, Argentina, 03000
  • Australien
    • New South Wales
      • Lismore, New South Wales, Australien, 2480
      • Newcastle, New South Wales, Australien, 2298
      • Port Macquarie, New South Wales, Australien, 2444
      • Wahroonga, New South Wales, Australien, 2076
      • Wollongong, New South Wales, Australien, 2500
    • Queensland
      • Auchenflower, Queensland, Australien, 4066
      • Nambour, Queensland, Australien, 4560
    • Victoria
      • Fitzroy, Victoria, Australien, 3065
      • Geelong, Victoria, Australien, 3220
    • Western Australia
      • Perth, Western Australia, Australien, 6000
  • Bosnien-Hercegovina
      • Banja Luka, Bosnien-Hercegovina, 78000
      • Sarajevo, Bosnien-Hercegovina, 71000
      • Tuzla, Bosnien-Hercegovina, 75000
  • Brasilien
    • GO
      • Goiania, GO, Brasilien, 74605-070
    • RS
      • Porto Alegre, RS, Brasilien, 90610-000
    • SC
      • Florianopolis, SC, Brasilien, 88034-000
    • SP
      • Barretos, SP, Brasilien, 14784-400
      • Sao Paulo, SP, Brasilien, 01509-010
  • Canada
      • Quebec, Canada, G1S 4L8
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
      • Sudbury, Ontario, Canada, P3E 5J1
      • Toronto, Ontario, Canada, M4N 3M5
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
      • Montreal, Quebec, Canada, H3T 1E2
      • Montreal, Quebec, Canada, H2W 1S6
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
  • Den Russiske Føderation
      • Kazan, Den Russiske Føderation, 420029
      • Moscow, Den Russiske Føderation, 115478
      • Obninsk, Den Russiske Føderation, 249036
      • Ryazan, Den Russiske Føderation, 390011
      • Saint-Petersburg, Den Russiske Føderation, 197758
      • UFA, Den Russiske Føderation, 450054
  • Det Forenede Kongerige
      • Exeter, Det Forenede Kongerige, EX2 5DW
      • London, Det Forenede Kongerige, SE1 7EH
      • Manchester, Det Forenede Kongerige, M20 4BX
      • Nottingham, Det Forenede Kongerige, NG5 1PB
      • Preston, Det Forenede Kongerige, PR2 9HT
      • Rhyl, Det Forenede Kongerige, LL18 5UJ
      • Stoke-on-Trent, Det Forenede Kongerige, ST4 6QG
      • Weston Super Mare, Det Forenede Kongerige, BS23 4TQ
  • Frankrig
      • Avignon, Frankrig, 84918
      • Besancon, Frankrig, 25030
      • Bordeaux, Frankrig, 33076
      • Caen, Frankrig, 14076
      • Clermont Ferrand, Frankrig, 63011
      • Dijon, Frankrig, 21079
      • Lille, Frankrig, 59020
      • Montpellier, Frankrig, 34298
      • Villejuif, Frankrig, 94805
  • Italien
    • Emilia-Romagna
      • Parma, Emilia-Romagna, Italien, 43100
    • Friuli-Venezia Giulia
      • Udine, Friuli-Venezia Giulia, Italien, 33100
    • Lombardia
      • Milano, Lombardia, Italien, 20133
      • Pavia, Lombardia, Italien, 27100
  • Kalkun
      • Izmir, Kalkun, 35100
      • Sıhhiye, ANKARA, Kalkun, 06100
  • Mexico
      • Acapulco, Mexico, 39850
      • Guadalajara, Mexico, 45100
      • Merida, Mexico, 97500
      • Monterrey, Mexico, 66260
      • Torreon, Mexico, 27000
  • Rumænien
      • Bucharest, Rumænien, 050098
      • Bucuresti, Rumænien, 022328
      • Cluj Napoca, Rumænien, 400015
      • Cluj-Napoca, Rumænien, 400015
      • Iasi, Rumænien, 700106
  • Spanien
      • Barcelona, Spanien, 08003
      • Cordoba, Spanien, 14004
      • Madrid, Spanien, 28046
      • Zaragoza, Spanien, 50009
    • Barcelona
      • Sabadell, Barcelona, Barcelona, Spanien, 08208
  • Tjekkiet
      • Praha 2, Tjekkiet, 128 08
      • Praha 5, Tjekkiet, 150 06
  • Uruguay
      • Montevideo, Uruguay, 11600
      • Montevideo, Uruguay, 11200
  • Østrig
      • Graz, Østrig, 8036
      • Salzburg, Østrig, 5020
      • Vöcklabruck, Østrig, 4840
      • Wien, Østrig, 1090

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • HER2 positive breast cancer with locally recurrent or metastatic lesions;
  • eligible for chemotherapy;
  • baseline LVEF >=50%.

Exclusion Criteria:

  • previous chemotherapy for metastatic or locally recurrent breast cancer;
  • previous radiotherapy for metastatic breast cancer (except for metastatic bone pain relief);
  • other primary tumor within last 5 years, with the exception of basal or squamous skin cancer, or in situ cancer of the cervix;
  • clinically significant cardiovascular disease;
  • chronic daily treatment with aspirin (>325mg/day) or clopidogrel (>75mg/day).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Medicin: bevacizumab [Avastin]
15 mg/kg iv hver 3. uge
Medicin: Docetaxel
100mg/m2 iv every 3 weeks
Medicin: Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks
Aktiv komparator: 2
Medicin: Docetaxel
100mg/m2 iv every 3 weeks
Medicin: Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression Free Survival (PFS)
Tidsramme: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
PFS was defined as the time from randomization to time of first documented disease progression (unequivocal progression of existing non-target lesions) or death, whichever occurred first as assessed by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0). Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. Primary PFS variable was defined based on the investigators' assessments and the statistical conclusions on the primary efficacy endpoint were based on investigator assessed PFS. PFS was estimated using Kaplan-Meier methods.
Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
OS was defined as the time from randomization to the date of death, regardless of the cause of death. OS was estimated using Kaplan-Meier methods.
Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR) in Participants With Measurable Disease at Baseline
Tidsramme: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Best OR was assessed using RECIST v1.0 criteria. Participants were classified as responders if their best OR was either confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of the longest diameter [LD] of target lesions, taking as reference the baseline sum LD). Participants without any post-baseline assessments were regarded as non-responders. The 95% CI for the one sample binomial using Pearson-Clopper method.
Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Duration of Response (DR)
Tidsramme: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
DR was defined as the time when response (CR or PR per RECIST v1.0) was first documented to the date of disease progression per RECIST v1.0 (unequivocal progression of existing non-target lesions) or death. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.
Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Time to Treatment Failure (TTF)
Tidsramme: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
TTF was defined as the time between randomization and date of disease progression (per RECIST v1.0; unequivocal progression of existing non-target lesions), death, or withdrawal of treatment due to adverse events, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.
Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Tidsramme: Baseline, Cycles 3, 5, 11, and post progressive disease (PD; 14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])
FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.
Baseline, Cycles 3, 5, 11, and post progressive disease (PD; 14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])
Change From Baseline for FACT-G and FACT-B
Tidsramme: Baseline, Cycles 3, 5, 11, and post PD (14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])
FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.
Baseline, Cycles 3, 5, 11, and post PD (14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2006

Primær færdiggørelse (Faktiske)

1. august 2014

Studieafslutning (Faktiske)

1. august 2014

Datoer for studieregistrering

Først indsendt

20. oktober 2006

Først indsendt, der opfyldte QC-kriterier

20. oktober 2006

Først opslået (Skøn)

23. oktober 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. august 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. august 2015

Sidst verificeret

1. august 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BO20231

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Brystkræft

Kliniske forsøg med bevacizumab [Avastin]

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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