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Trastuzumab in Treating Older Women With Early-Stage Breast Cancer

16 juillet 2020 mis à jour par: Cynthia Owusu, MD

Safety and Efficacy of Single Agent Adjuvant Trastuzumab (Herceptin®) in Older Women With Early-Stage and Locally Advanced Breast Cancer: A Phase II Trial

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

PURPOSE: This phase II trial is studying the side effects of trastuzumab and to see how well it works in treating older women with early-stage breast cancer.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

OBJECTIVES:

Primary

  • To evaluate the 3-year cumulative incidence of cardiac events in women 60 years and older with HER2-positive breast cancer who receive single agent trastuzumab (Herceptin®) in the adjuvant setting.

Secondary

  • To evaluate the 1-year cumulative incidence of asymptomatic cardiac left ventricular dysfunction in women 60 years and older with Her2-positive breast cancer who receive single agent trastuzumab in the adjuvant setting.
  • To evaluate long-term cardiac toxicity (5-year cumulative incidence of cardiac events) in women 60 years and older with Her2-positive breast cancer who receive single agent trastuzumab in the adjuvant setting.
  • To assess the relation between physiologic markers of chronic heart failure and trastuzumab-related cardiac dysfunction in women 60 years and older with Her2-positive breast cancer who receive single agent trastuzumab.
  • To assess the relation between pro-inflammatory cytokines and trastuzumab-related cardiac dysfunction in women 60 years and older with Her2-positive breast cancer.
  • To determine the effect of this drug on the health-related quality of life and functional, cognitive, and mental status of women 60 years and older with Her2-positive breast cancer.
  • To determine the 5-year disease-free survival and overall survival of women 60 years and older with Her2-positive breast cancer who receive single agent trastuzumab in the adjuvant setting.

OUTLINE: This is a multicenter study.

Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α). Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52.

After completion of study therapy, patients are followed periodically for 4 years.

Type d'étude

Interventionnel

Inscription (Réel)

56

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Florida
      • Miami, Florida, États-Unis, 33136
        • University of Miami, Sylvester Comprehensive Cancer Center
    • North Carolina
      • Winston-Salem, North Carolina, États-Unis, 27157
        • Wake Forrest
    • Ohio
      • Cleveland, Ohio, États-Unis, 44121
        • University Suburban Health Center
      • Cleveland, Ohio, États-Unis, 44122
        • UHHS Chagrin Highlands Medical Center
      • Cleveland, Ohio, États-Unis, 44130
        • Southwest General Health Center
      • Cleveland, Ohio, États-Unis, 44145
        • UHHS Westlake Medical Center
      • Cleveland, Ohio, États-Unis, 44060
        • Lake/University Seidman Cancer Center
      • Cleveland, Ohio, États-Unis, 44106-5065
        • Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
      • Mayfield Heights, Ohio, États-Unis, 44124
        • UH-Monarch
      • Wadsworth, Ohio, États-Unis, 44281
        • Sharon Health Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, États-Unis, 15232
        • University of Pittsburgh

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

60 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the breast
  • Immunohistochemical staining for Her2 protein of 3+ intensity or Her2 gene amplification of ≥ 2.0 by FISH testing.
  • Life expectancy > 6 months
  • ECOG performance status ≤ 2
  • Node positive disease irrespective of tumor size

  • Node negative disease:

    • TNM Stage (AJCC Cancer Staging Manual 6th edition) T1b-T4, N0-3, M0, irrespective of hormonal status
  • Baseline LVEF ≥ lower limit of normal for a particular institution
  • Complete surgical removal of invasive cancer by mastectomy or lumpectomy
  • Complete staging work-up with CT of chest, abdomen, and pelvis plus bone scan or alternatively with PET scan for stage II and higher disease, or as determined by symptoms for all other stages. Additional staging work-up as per symptoms.

  • Adequate bone marrow function as indicated by the following:

    • ANC >1000/µL
    • Platelets ≥100,000/µL
    • Hemoglobin >10 g/dL
  • Adequate liver function, as indicated by bilirubin ≤1.5 x upper limit of normal (ULN) Adequate renal function, as indicated by creatinine ≤1.5 x ULN
  • AST or ALT <2 x ULN unless related to primary disease.
  • Signed informed consent

Exclusion Criteria:

  • Enrollment after more than 120 days from the last day of mastectomy or lumpectomy
  • Patients able to tolerate and willing to receive chemotherapy
  • Prior chemotherapy for current malignancy
  • Prior herceptin therapy

  • Active cardiac disease

    • Myocardial infarction (asymptomatic changes on EKG suggestive of old MI is not an exclusion)
    • Angina pectoris requiring anti-anginal treatment
    • Documented congestive heart failure (CHF)
    • Current use of any therapy specifically for CHF
    • Cardiac arrhythmia requiring medication
    • Current uncontrolled hypertension (diastolic >100 mmHg or systolic > 200 mmHg)
    • Clinically significant valvular abnormality (associated with New York Heart Association (NYHA) class II, III, or IV symptoms)
    • Clinically significant pericardial effusion (associated with New York Heart Association (NYHA) class II, III, or IV symptoms)

  • Past cardiac disease

    • Prior myocardial infarction (asymptomatic changes on EKG suggestive of old MI is not an exclusion)
    • Prior history of CHF
    • History of cardiomyopathy

  • Other diseases and conditions

    • Evidence of metastatic breast cancer (clinical or radiological evidence)
    • Active infection
    • Concomitant malignancies or previous malignancies within the last 3 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
    • Hypersensitivity to trastuzumab

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: le trastuzumab
Biologique: trastuzumab
Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
Autres noms:
  • Herceptine
Autre: laboratory biomarker analysis
Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).
Procédure: adjuvant therapy
Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
Procédure: quality-of-life assessment
Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percent of Participants Experiencing Cardiac Events at 1 Year
Délai: At 1 year
Number of participants that experience cardiac events that include cardiac death due to congestive heart failure (CHF), Myocardial infarction (MI) or documented arrhythmia, death without definitive cause, or signs and symptoms of CHF as defined by New York Heart Association (NYHA) class III or IV symptoms.
At 1 year

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percent of Participants Experiencing Cardiac Events at 3 Years
Délai: At 3 years
Number of participants that experience cardiac events that include cardiac death due to congestive heart failure (CHF), Myocardial infarction (MI) or documented arrhythmia, death without definitive cause, or signs and symptoms of CHF as defined by New York Heart Association (NYHA) class III or IV symptoms.
At 3 years
Percent of Participants Experiencing Cardiac Events at 5 Years
Délai: At 5 years
Number of participants that experience cardiac events that include cardiac death due to congestive heart failure (CHF), Myocardial infarction (MI) or documented arrhythmia, death without definitive cause, or signs and symptoms of CHF as defined by New York Heart Association (NYHA) class III or IV symptoms.
At 5 years
Percent of Participants of Asymptomatic Left Ventricular (LV) Cardiac Dysfunction at 1 Year
Délai: At 1 year
One-year cumulative incidence of LV cardiac dysfunction as measured by percent of participants that had asymptomatic LV cardiac dysfunction with/without permanent discontinuation
At 1 year
Percent of Participants With Asymptomatic LV Cardiac Dysfunction at Three Years
Délai: At 3 years
Three-year cumulative incidence of LV cardiac dysfunction as measured by percent of participants that had asymptomatic LV cardiac dysfunction with/without permanent discontinuation
At 3 years
Percent of Participants With Asymptomatic LV Cardiac Dysfunction at Five Years
Délai: At 5 years
Five-year cumulative incidence as measured by percent of participants that had asymptomatic LV cardiac dysfunction with/without permanent discontinuation
At 5 years
Percent of Participants With Disease-free Survival (DFS)
Délai: At 1 year
Percent of participants with DFS measured between the time from initiation of treatment to the date of first loco-regional or distant treatment failure, ignoring any intervening contralateral breast cancers or other second primary cancers. Deaths without evidence of recurrence will be treated censoring events.
At 1 year
Percent of Participants With DFS
Délai: At 2 years
Percent of participants with DFS measured between the time from initiation of treatment to the date of first loco-regional or distant treatment failure, ignoring any intervening contralateral breast cancers or other second primary cancers. Deaths without evidence of recurrence will be treated censoring events.
At 2 years
Percent of Participants With Disease-free Survival (DFS)
Délai: At 3 years
Percent of participants with DFS measured between the time from initiation of treatment to the date of first loco-regional or distant treatment failure, ignoring any intervening contralateral breast cancers or other second primary cancers. Deaths without evidence of recurrence will be treated censoring events.
At 3 years
Percent of Participants With Disease-free Survival (DFS)
Délai: At 5 years
Percent of participants with DFS measured between the time from initiation of treatment to the date of first loco-regional or distant treatment failure, ignoring any intervening contralateral breast cancers or other second primary cancers. Deaths without evidence of recurrence will be treated censoring events.
At 5 years
Overall Survival (OS) as Measured by Percent of Participants Alive at 1 Year
Délai: Up to 1 years
OS defined as percent of participants alive between time from initiation of treatment to the date of protocol-defined outcome from any cause and censored to the date of last follow-up for survivors.
Up to 1 years
Overall Survival (OS) as Measured by Percent of Participants Alive at 2 Years
Délai: Up to 2 years
OS defined as percent of participants alive between time from initiation of treatment to the date of protocol-defined outcome from any cause and censored to the date of last follow-up for survivors.
Up to 2 years
Overall Survival (OS) as Measured by Percent of Participants Alive at 3 Years
Délai: Up to 3 years
OS defined as percent of participants alive between time from initiation of treatment to the date of protocol-defined outcome from any cause and censored to the date of last follow-up for survivors.
Up to 3 years
Overall Survival (OS) as Measured by Percent of Participants Alive at 5 Years
Délai: Up to 5 years
OS defined as percent of participants alive between time from initiation of treatment to the date of protocol-defined outcome from any cause and censored to the date of last follow-up for survivors.
Up to 5 years
Mean Change in Quality of Life and Comprehensive Geriatric Assessment Scores From Baseline to Mid-treatment and Baseline to End of Treatment
Délai: Baseline to week 26 and baseline to 52 weeks after being on study
Baseline to week 26 and baseline to 52 weeks after being on study

Autres mesures de résultats

Mesure des résultats
Délai
Mean Change in Pro-inflammatory Cytokines From Baseline to Mid-treatment and Baseline to End of Treatment
Délai: Every 6 weeks during treatment up to three years
Every 6 weeks during treatment up to three years
Mean Change in Plasma Cardiac Markers From Baseline to Mid-treatment and Baseline to End of Treatment
Délai: Every 6 weeks during treatment up to three years
Every 6 weeks during treatment up to three years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Cynthia Owusu, MD

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

  • Chercheur principal: Cynthia Owusu, MD, MSc, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

11 novembre 2008

Achèvement primaire (Réel)

12 janvier 2018

Achèvement de l'étude (Réel)

12 janvier 2019

Dates d'inscription aux études

Première soumission

21 novembre 2008

Première soumission répondant aux critères de contrôle qualité

21 novembre 2008

Première publication (Estimation)

24 novembre 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 août 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 juillet 2020

Dernière vérification

1 juillet 2020

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CASE10107 (Autre identifiant: Case Comprehensive Cancer Center)
  • P30CA043703 (Subvention/contrat des NIH des États-Unis)
  • CASE-10107-CC443 (Autre identifiant: Cancer Center IRB)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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