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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

424

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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
  • Australia
    • New South Wales
      • Lismore, New South Wales, Australia, 2480
      • Newcastle, New South Wales, Australia, 2298
      • Port Macquarie, New South Wales, Australia, 2444
      • Wahroonga, New South Wales, Australia, 2076
      • Wollongong, New South Wales, Australia, 2500
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
      • Nambour, Queensland, Australia, 4560
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
      • Geelong, Victoria, Australia, 3220
    • Western Australia
      • Perth, Western Australia, Australia, 6000
  • Bosnia og Herzegovina
      • Banja Luka, Bosnia og Herzegovina, 78000
      • Sarajevo, Bosnia og Herzegovina, 71000
      • Tuzla, Bosnia og Herzegovina, 75000
  • Brasil
    • GO
      • Goiania, GO, Brasil, 74605-070
    • RS
      • Porto Alegre, RS, Brasil, 90610-000
    • SC
      • Florianopolis, SC, Brasil, 88034-000
    • SP
      • Barretos, SP, Brasil, 14784-400
      • Sao Paulo, SP, Brasil, 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 føderasjonen
      • Kazan, Den russiske føderasjonen, 420029
      • Moscow, Den russiske føderasjonen, 115478
      • Obninsk, Den russiske føderasjonen, 249036
      • Ryazan, Den russiske føderasjonen, 390011
      • Saint-Petersburg, Den russiske føderasjonen, 197758
      • UFA, Den russiske føderasjonen, 450054
  • Frankrike
      • Avignon, Frankrike, 84918
      • Besancon, Frankrike, 25030
      • Bordeaux, Frankrike, 33076
      • Caen, Frankrike, 14076
      • Clermont Ferrand, Frankrike, 63011
      • Dijon, Frankrike, 21079
      • Lille, Frankrike, 59020
      • Montpellier, Frankrike, 34298
      • Villejuif, Frankrike, 94805
  • Italia
    • Emilia-Romagna
      • Parma, Emilia-Romagna, Italia, 43100
    • Friuli-Venezia Giulia
      • Udine, Friuli-Venezia Giulia, Italia, 33100
    • Lombardia
      • Milano, Lombardia, Italia, 20133
      • Pavia, Lombardia, Italia, 27100
  • Mexico
      • Acapulco, Mexico, 39850
      • Guadalajara, Mexico, 45100
      • Merida, Mexico, 97500
      • Monterrey, Mexico, 66260
      • Torreon, Mexico, 27000
  • Romania
      • Bucharest, Romania, 050098
      • Bucuresti, Romania, 022328
      • Cluj Napoca, Romania, 400015
      • Cluj-Napoca, Romania, 400015
      • Iasi, Romania, 700106
  • Spania
      • Barcelona, Spania, 08003
      • Cordoba, Spania, 14004
      • Madrid, Spania, 28046
      • Zaragoza, Spania, 50009
    • Barcelona
      • Sabadell, Barcelona, Barcelona, Spania, 08208
  • Storbritannia
      • Exeter, Storbritannia, EX2 5DW
      • London, Storbritannia, SE1 7EH
      • Manchester, Storbritannia, M20 4BX
      • Nottingham, Storbritannia, NG5 1PB
      • Preston, Storbritannia, PR2 9HT
      • Rhyl, Storbritannia, LL18 5UJ
      • Stoke-on-Trent, Storbritannia, ST4 6QG
      • Weston Super Mare, Storbritannia, BS23 4TQ
  • Tsjekkisk Republikk
      • Praha 2, Tsjekkisk Republikk, 128 08
      • Praha 5, Tsjekkisk Republikk, 150 06
  • Tyrkia
      • Izmir, Tyrkia, 35100
      • Sıhhiye, ANKARA, Tyrkia, 06100
  • Uruguay
      • Montevideo, Uruguay, 11600
      • Montevideo, Uruguay, 11200
  • Østerrike
      • Graz, Østerrike, 8036
      • Salzburg, Østerrike, 5020
      • Vöcklabruck, Østerrike, 4840
      • Wien, Østerrike, 1090

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 1
Legemiddel: bevacizumab [Avastin]
15 mg/kg iv hver 3. uke
Legemiddel: Docetaxel
100mg/m2 iv every 3 weeks
Legemiddel: Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks
Aktiv komparator: 2
Legemiddel: Docetaxel
100mg/m2 iv every 3 weeks
Legemiddel: Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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])

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hoffmann-La Roche

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2006

Primær fullføring (Faktiske)

1. august 2014

Studiet fullført (Faktiske)

1. august 2014

Datoer for studieregistrering

Først innsendt

20. oktober 2006

Først innsendt som oppfylte QC-kriteriene

20. oktober 2006

Først lagt ut (Anslag)

23. oktober 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

28. august 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. august 2015

Sist bekreftet

1. august 2015

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • BO20231

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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