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

21 agosto 2015 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

424

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • 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
  • Austria
      • Graz, Austria, 8036
      • Salzburg, Austria, 5020
      • Vöcklabruck, Austria, 4840
      • Wien, Austria, 1090
  • Bosnia Erzegovina
      • Banja Luka, Bosnia Erzegovina, 78000
      • Sarajevo, Bosnia Erzegovina, 71000
      • Tuzla, Bosnia Erzegovina, 75000
  • Brasile
    • GO
      • Goiania, GO, Brasile, 74605-070
    • RS
      • Porto Alegre, RS, Brasile, 90610-000
    • SC
      • Florianopolis, SC, Brasile, 88034-000
    • SP
      • Barretos, SP, Brasile, 14784-400
      • Sao Paulo, SP, Brasile, 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
  • Federazione Russa
      • Kazan, Federazione Russa, 420029
      • Moscow, Federazione Russa, 115478
      • Obninsk, Federazione Russa, 249036
      • Ryazan, Federazione Russa, 390011
      • Saint-Petersburg, Federazione Russa, 197758
      • UFA, Federazione Russa, 450054
  • Francia
      • Avignon, Francia, 84918
      • Besancon, Francia, 25030
      • Bordeaux, Francia, 33076
      • Caen, Francia, 14076
      • Clermont Ferrand, Francia, 63011
      • Dijon, Francia, 21079
      • Lille, Francia, 59020
      • Montpellier, Francia, 34298
      • Villejuif, Francia, 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
  • Messico
      • Acapulco, Messico, 39850
      • Guadalajara, Messico, 45100
      • Merida, Messico, 97500
      • Monterrey, Messico, 66260
      • Torreon, Messico, 27000
  • Regno Unito
      • Exeter, Regno Unito, EX2 5DW
      • London, Regno Unito, SE1 7EH
      • Manchester, Regno Unito, M20 4BX
      • Nottingham, Regno Unito, NG5 1PB
      • Preston, Regno Unito, PR2 9HT
      • Rhyl, Regno Unito, LL18 5UJ
      • Stoke-on-Trent, Regno Unito, ST4 6QG
      • Weston Super Mare, Regno Unito, BS23 4TQ
  • Repubblica Ceca
      • Praha 2, Repubblica Ceca, 128 08
      • Praha 5, Repubblica Ceca, 150 06
  • Romania
      • Bucharest, Romania, 050098
      • Bucuresti, Romania, 022328
      • Cluj Napoca, Romania, 400015
      • Cluj-Napoca, Romania, 400015
      • Iasi, Romania, 700106
  • Spagna
      • Barcelona, Spagna, 08003
      • Cordoba, Spagna, 14004
      • Madrid, Spagna, 28046
      • Zaragoza, Spagna, 50009
    • Barcelona
      • Sabadell, Barcelona, Barcelona, Spagna, 08208
  • Tacchino
      • Izmir, Tacchino, 35100
      • Sıhhiye, ANKARA, Tacchino, 06100
  • Uruguay
      • Montevideo, Uruguay, 11600
      • Montevideo, Uruguay, 11200

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 1
Droga: bevacizumab [Avastin]
15 mg/kg iv ogni 3 settimane
Droga: Docetaxel
100mg/m2 iv every 3 weeks
Droga: Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks
Comparatore attivo: 2
Droga: Docetaxel
100mg/m2 iv every 3 weeks
Droga: Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression Free Survival (PFS)
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival (OS)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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])

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hoffmann-La Roche

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2006

Completamento primario (Effettivo)

1 agosto 2014

Completamento dello studio (Effettivo)

1 agosto 2014

Date di iscrizione allo studio

Primo inviato

20 ottobre 2006

Primo inviato che soddisfa i criteri di controllo qualità

20 ottobre 2006

Primo Inserito (Stima)

23 ottobre 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

28 agosto 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 agosto 2015

Ultimo verificato

1 agosto 2015

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BO20231

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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