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

15. marts 2019 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

74

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Den Russiske Føderation
      • Kazan, Den Russiske Føderation, 420029
        • St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"
      • Krasnodar, Den Russiske Føderation, 350040
        • Clinical Oncology Dispensary No. 1, Dept. Chemotherapy
      • Moscow, Den Russiske Føderation, 129128
        • N.A. Semashko Central Clinical Hospital, Moscow
      • Pyatigorsk, Den Russiske Føderation, 357502
        • SBIH of Stavropol territory "Pyatigorsk Oncol. Dispensary"
      • Samara, Den Russiske Føderation, 443 031
        • SBIH "Samara Regional Clinical Oncol. Dispensary", Samara
      • Sochi, Den Russiske Føderation, 354057
        • GUZ "Oncological Dispesary #2"
      • Stavropol, Den Russiske Føderation, 355 047
        • Stavropol Regional Clin. Oncology Dispensary Dept. Oncology
      • Yaroslavl, Den Russiske Føderation, 150 040
        • Yaroslavl Regional Clinical Oncology Hosp. Dept.Chemotherapy
  • Det Forenede Kongerige
      • Barnstaple, Det Forenede Kongerige, EX31 4JB
        • North Devon District Hospital
      • Bournemouth, Det Forenede Kongerige, BH7 7DW
        • Royal Bournemouth and Christchurch Hospital
      • Exeter, Det Forenede Kongerige, EX2 5DW
        • Royal Devon and Exeter Hospital
      • London, Det Forenede Kongerige, W6 8RF
        • Charing Cross Hospital
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Shatin, Hong Kong
        • Prince of Wales Hospital
  • Indien
      • Amravati, Indien, 444606
        • Sujan Surgical Cancer Hospital
      • Maharashtra, Indien, 422 004
        • Curie Manavata Cancer Centre
      • Maharashtra, Indien, 400 012
        • Tata Memorial Hospital
      • Nagpur, Indien, 440010
        • Central India Cancer Research Institute
      • Pune, Indien, 411001
        • Ruby Hall Clinic
      • Thiruvananthapuram, Indien, 695 011
        • Regional Cancer Center
  • Polen
      • Gdansk, Polen, 80-211
        • University Clinical Center, Gdansk
  • 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

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

Kvinde

Beskrivelse

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

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: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Afatinib 40mg once daily (OD)
Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease
Medicin: Afatinib 40mg once daily (OD)
Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease
Eksperimentel: Paclitaxel 80 mg/m2 weekly
Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy
Medicin: Paclitaxel 80 mg/m2 weekly
Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy
Eksperimentel: Vinorelbine 25 mg/m2 weekly
Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy
Medicin: Vinorelbine 25 mg/m2 weekly
Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version (RECIST) 1.1
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Best Overall Response According to RECIST v1.1 (With Confirmation)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

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

Sponsor

Boehringer Ingelheim

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

Hjælpsomme links

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 (Faktiske)

24. maj 2011

Primær færdiggørelse (Faktiske)

13. marts 2017

Studieafslutning (Faktiske)

13. marts 2017

Datoer for studieregistrering

Først indsendt

6. januar 2011

Først indsendt, der opfyldte QC-kriterier

6. januar 2011

Først opslået (Skøn)

7. januar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

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 .

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