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A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting

NCT01808573

Description:

This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

A Study of <span class="go-doc-concept go-doc-intervention">Neratinib</span> Plus <span class="go-doc-concept go-doc-intervention">Capecitabine</span> Versus <span class="go-doc-concept go-doc-intervention">Lapatinib</span> Plus <span class="go-doc-concept go-doc-intervention">Capecitabine</span> in Patients With <span class="go-doc-concept go-doc-biomarker">HER2</span>+ Metastatic <span class="go-doc-concept go-doc-disease">Breast Cancer</span> Who Have Received Two or More Prior <span class="go-doc-concept go-doc-biomarker">HER2</span> Directed Regimens in the Metastatic Setting

Title

  • Brief Title: A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting
  • Official Title: A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting
  • Clinical Trial IDs

    NCT ID: NCT01808573

    ORG ID: PUMA-NER-1301

    NCI ID: 2012-004492-38

    Trial Conditions

    HER2+ Metastatic Breast Cancer (MBC)

    Trial Interventions

    Drug Synonyms Arms
    neratinib neratinib plus capecitabine
    capecitabine Xeloda neratinib plus capecitabine
    lapatinib Tykerb, Tyverb lapatinib plus capecitabine
    capecitabine Xeloda lapatinib plus capecitabine

    Trial Purpose

    This is a randomized, multi-center, multinational, open-label, active-controlled, parallel
    design study of the combination of neratinib plus capecitabine versus the combination of
    lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2
    directed regimens in the metastatic setting.

    Detailed Description

    This is a randomized, multi-center, multinational, open-label, active-controlled, parallel
    design study of the combination of neratinib plus capecitabine versus the combination of
    lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2
    directed regimens in the metastatic setting. Patients will be randomized in a 1:1 ratio to
    one of the following treatment arms:

    - Arm A: neratinib (240 mg once daily) + capecitabine (1500 mg/m^2 daily, 750 mg/m^2
    twice daily [BID])

    - Arm B: lapatinib (1250 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2
    BID)

    Patients will receive either neratinib plus capecitabine combination or lapatinib plus
    capecitabine combination until the occurrence of death, disease progression, unacceptable
    toxicity, or other specified withdrawal criterion.

    Trial Arms

    Name Type Description Interventions
    neratinib plus capecitabine Experimental neratinib, capecitabine
    lapatinib plus capecitabine Active Comparator lapatinib, capecitabine

    Eligibility Criteria

    Inclusion Criteria:

    - Aged 18 years at signing of informed consent.

    - Histologically confirmed MBC, current stage IV.

    - Documented HER2 overexpression or gene-amplified tumor (immunohistochemistry [IHC] 3+
    or IHC 2+ with confirmatory fluorescence in situ hybridization [FISH]+).

    - Prior treatment with at least two (2) HER2-directed regimens for metastatic breast
    cancer.

    Exclusion Criteria:

    - Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2
    directed tyrosine kinase inhibitor.

    Note: There are additional inclusion and exclusion criteria. The study center will
    determine if you meet all of the criteria.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Independently assessed Progression Free Survival

    Overall Survival

    Secondary Outcome Measures

    Investigator Assessed Progression Free Survival

    Objective Response Rate (ORR)

    Clinical Benefit Rate (CBR)

    Duration of Response (DOR)

    Time to intervention for symptomatic metastatic central nervous system disease

    Safety (Adverse Events [AEs] and Serious Adverse Events [SAEs])

    Health Outcomes Assessments

    Trial Keywords