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Trastuzumab in Treating Older Women With Early-Stage Breast Cancer

16. juli 2020 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

56

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

60 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Andre navn:
  • Herceptin
Annen: 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).
Fremgangsmåte: 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.
Fremgangsmåte: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percent of Participants Experiencing Cardiac Events at 1 Year
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percent of Participants Experiencing Cardiac Events at 3 Years
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Cynthia Owusu, MD

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. november 2008

Primær fullføring (Faktiske)

12. januar 2018

Studiet fullført (Faktiske)

12. januar 2019

Datoer for studieregistrering

Først innsendt

21. november 2008

Først innsendt som oppfylte QC-kriteriene

21. november 2008

Først lagt ut (Anslag)

24. november 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. august 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juli 2020

Sist bekreftet

1. juli 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CASE10107 (Annen identifikator: Case Comprehensive Cancer Center)
  • P30CA043703 (U.S. NIH-stipend/kontrakt)
  • CASE-10107-CC443 (Annen identifikator: Cancer Center IRB)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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