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LUX-Breast 2; Afatinib in HER2 (Human Epidermal Growth Factor Receptor)-Treatment Failures

15 marzo 2019 aggiornato da: Boehringer Ingelheim

LUX-Breast 2; An Open Label, Phase II Trial of Afatinib (BIBW 2992) in Patients With Metastatic HER2-overexpressing Breast Cancer Failing HER2-targeted Treatment in the Neoadjuvant and/or Adjuvant Treatment Setting

The general aim of this study is to investigate the efficacy and safety of afatinib (BIBW 2992) alone and in combination with weekly paclitaxel or weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed HER2-targeted treatment in the neoadjuvant or adjuvant setting

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

74

Fase

  • Fase 2

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

  • Federazione Russa
      • Kazan, Federazione Russa, 420029
        • St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"
      • Krasnodar, Federazione Russa, 350040
        • Clinical Oncology Dispensary No. 1, Dept. Chemotherapy
      • Moscow, Federazione Russa, 129128
        • N.A. Semashko Central Clinical Hospital, Moscow
      • Pyatigorsk, Federazione Russa, 357502
        • SBIH of Stavropol territory "Pyatigorsk Oncol. Dispensary"
      • Samara, Federazione Russa, 443 031
        • SBIH "Samara Regional Clinical Oncol. Dispensary", Samara
      • Sochi, Federazione Russa, 354057
        • GUZ "Oncological Dispesary #2"
      • Stavropol, Federazione Russa, 355 047
        • Stavropol Regional Clin. Oncology Dispensary Dept. Oncology
      • Yaroslavl, Federazione Russa, 150 040
        • Yaroslavl Regional Clinical Oncology Hosp. Dept.Chemotherapy
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Shatin, Hong Kong
        • Prince of Wales Hospital
  • India
      • Amravati, India, 444606
        • Sujan Surgical Cancer Hospital
      • Maharashtra, India, 422 004
        • Curie Manavata Cancer Centre
      • Maharashtra, India, 400 012
        • Tata Memorial Hospital
      • Nagpur, India, 440010
        • Central India Cancer Research Institute
      • Pune, India, 411001
        • Ruby Hall Clinic
      • Thiruvananthapuram, India, 695 011
        • Regional Cancer Center
  • Polonia
      • Gdansk, Polonia, 80-211
        • University Clinical Center, Gdansk
  • Regno Unito
      • Barnstaple, Regno Unito, EX31 4JB
        • North Devon District Hospital
      • Bournemouth, Regno Unito, BH7 7DW
        • Royal Bournemouth and Christchurch Hospital
      • Exeter, Regno Unito, EX2 5DW
        • Royal Devon and Exeter Hospital
      • London, Regno Unito, W6 8RF
        • Charing Cross Hospital
  • Taiwan
      • Taichung, Taiwan, 404
        • China Medical University Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taipei, Taiwan, 10449
        • MacKay Memorial Hospital
      • Taipei, Taiwan, 112
        • Taipe Veterans General Hospital
      • Taipei, Taiwan, 112
        • Koo Foundation Sun Yet-Sen Cancer Center

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

Femmina

Descrizione

Inclusion criteria:

  1. Female patients >=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer
  2. Stage IV metastatic disease
  3. At least one measurable lesion according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1). Skin, bone and brain lesions are considered non-target lesions
  4. Must have failed or progressed on either trastuzumab or lapatinib or trastuzumab and lapatinib treatment in the neoadjuvant and/or adjuvant setting

Exclusion criteria:

  1. Prior first line therapy for metastatic breast cancer
  2. Known pre-existing interstitial lung disease
  3. Active brain metastases
  4. History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to trial treatment.
  5. Cardiac left ventricular function with resting ejection fraction of less than 50%.
  6. Prior treatment with Epidermal Growth Factor Receptor (EGFR)/HER2-targeted small molecules or antibodies other than trastuzumab and lapatinib in the neoadjuvant or adjuvant setting
  7. Prior treatment with paclitaxel in the past 12 months
  8. Must not have received prior vinorelbine treatment - Further exclusion criteria apply

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: Non randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Afatinib 40mg once daily (OD)
Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease
Droga: Afatinib 40mg once daily (OD)
Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease
Sperimentale: Paclitaxel 80 mg/m2 weekly
Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy
Droga: Paclitaxel 80 mg/m2 weekly
Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy
Sperimentale: Vinorelbine 25 mg/m2 weekly
Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy
Droga: Vinorelbine 25 mg/m2 weekly
Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version (RECIST) 1.1
Lasso di tempo: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Objective response according to RECIST v1.1. Best overall response of confirmed complete response (CR) or confirmed partial response (PR) recorded since first administration of trial medication and until the earliest of disease progression, death or start of next treatment in each part separately. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. Percentage of participants with OR along with exact 95% Confidence Interval by Clopper and Pearson is presented.
From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Best Overall Response According to RECIST v1.1 (With Confirmation)
Lasso di tempo: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Best overall response was assessed according to RECIST version 1.1 and was calculated relative to the baseline of each respective part .Percentage of participants with best overall response along with exact 95% Confidence Interval by Clopper and Pearson is presented. Best overall response was defined as the best response recorded at any time from the first administration of drug to the End of Treatment (EOT). As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Best Overall Response According to RECIST v1.1 (Regardless of Confirmation)
Lasso di tempo: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Best overall response was assessed according to RECIST version 1.1 and was calculated relative to the baseline of each respective part (without clinical disease assessment) .Percentage of participants with best overall response along with exact 95% Confidence Interval by Clopper and Pearson is presented. Best overall response was defined as the best response recorded at any time from the first administration of drug to the End of Treatment (EOT). As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Progression Free Survival (PFS)
Lasso di tempo: From drug start date in monotherapy to 1st disease progression and drug start date in combination therapy to 2nd disease progression
Progression Free Survival is defined as the time from the drug start date to the date of 1st disease progression or death for monotherapy and 2nd disease progression or death from the drug start date of the combination therapy for combination therapy'. Median is calculated from the Kaplan-Meier curve.
From drug start date in monotherapy to 1st disease progression and drug start date in combination therapy to 2nd disease progression
Duration of Objective Response According to RECIST v1.1
Lasso di tempo: From the first objective response to the time of progression or death, up to 1562 days
Duration of objective response, defined as the time from first objective response to the time of progression or death. (regardless of confirmation). As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
From the first objective response to the time of progression or death, up to 1562 days
Percentage of Patients With Highest Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade of 3 or Higher
Lasso di tempo: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Percentage of patients with highest common terminology criteria for adverse events (CTCAE) version 3.0 Grade of 3 or higher.
From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Change From Baseline to End of Treatment in Systolic Blood Pressure (SBP)
Lasso di tempo: Baseline and End of treatment period, up to 1562 days
Change from baseline to end of treatment in systolic blood pressure (SBP).
Baseline and End of treatment period, up to 1562 days
Change From Baseline to End of Treatment in Diastolic Blood Pressure (DBP)
Lasso di tempo: Baseline and End of treatment period, up to 1562 days
Change from baseline to end of treatment in diastolic blood pressure (DBP).
Baseline and End of treatment period, up to 1562 days
Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values
Lasso di tempo: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Number of patient with possibly clinically significant (PCS) laboratory values by functional group (haematology, differentials, coagulation, electrolytes, enzymes, and substrates). Acronyms Used: Prothrombin time-International normalized ratio (PT-INR), Alanine aminotransferase/Glutamic pyruvic transaminase (ALT/GPT) Serum glutamic pyruvic transaminase (SGPT), Aspartate aminotransferase/Glutamic-oxaloacetic transaminase (AST/GOT) Serum glutamic-oxaloacetic transaminase (SGOT)
From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days

Collaboratori e investigatori

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

Sponsor

Boehringer Ingelheim

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

Collegamenti utili

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 (Effettivo)

24 maggio 2011

Completamento primario (Effettivo)

13 marzo 2017

Completamento dello studio (Effettivo)

13 marzo 2017

Date di iscrizione allo studio

Primo inviato

6 gennaio 2011

Primo inviato che soddisfa i criteri di controllo qualità

6 gennaio 2011

Primo Inserito (Stima)

7 gennaio 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 giugno 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 marzo 2019

Ultimo verificato

1 marzo 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1200.98
  • 2010-021945-29 (Numero EudraCT)

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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