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Trastuzumab in Treating Older Women With Early-Stage Breast Cancer

16 juli 2020 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

56

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

60 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: trastuzumab
Biologisk: 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.
Andra namn:
  • Herceptin
Övrig: 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).
Procedur: 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.
Procedur: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percent of Participants Experiencing Cardiac Events at 1 Year
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percent of Participants Experiencing Cardiac Events at 3 Years
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Tidsram
Mean Change in Pro-inflammatory Cytokines From Baseline to Mid-treatment and Baseline to End of Treatment
Tidsram: 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
Tidsram: Every 6 weeks during treatment up to three years
Every 6 weeks during treatment up to three years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Cynthia Owusu, MD

Samarbetspartners

National Cancer Institute (NCI)

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

11 november 2008

Primärt slutförande (Faktisk)

12 januari 2018

Avslutad studie (Faktisk)

12 januari 2019

Studieregistreringsdatum

Först inskickad

21 november 2008

Först inskickad som uppfyllde QC-kriterierna

21 november 2008

Första postat (Uppskatta)

24 november 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 augusti 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 juli 2020

Senast verifierad

1 juli 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CASE10107 (Annan identifierare: Case Comprehensive Cancer Center)
  • P30CA043703 (U.S.S. NIH-anslag/kontrakt)
  • CASE-10107-CC443 (Annan identifierare: Cancer Center IRB)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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