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A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment

NCT01702571

Description:

This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

A Study of Kadcyla (<span class="go-doc-concept go-doc-intervention">Trastuzumab Emtansine</span>) in Patients With <span class="go-doc-concept go-doc-biomarker">HER2</span> Positive <span class="go-doc-concept go-doc-disease">Breast Cancer</span> Who Have Received Prior Anti-<span class="go-doc-concept go-doc-biomarker">HER2</span> And <span class="go-doc-concept go-doc-intervention">Chemotherapy</span>-based Treatment

Title

  • Brief Title: A Study of Kadcyla (Trastuzumab Emtansine) in Patients With HER2 Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment
  • Official Title: A Two-cohort, Open-label, Multicenter Study of Trastuzumab Emtansine (T-DM1) in HER2-positive Locally Advanced or Metastatic Breast Cancer Patients Who Have Received Prior Anti-HER2 and Chemotherapy-based Treatment.
  • Clinical Trial IDs

    NCT ID: NCT01702571

    ORG ID: MO28231

    NCI ID: 2012-001628-37

    Trial Conditions

    Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    Kadcyla (trastuzumab emtansine) Cohort 1, Cohort 2

    Trial Purpose

    This two-cohort, open-label, multicenter study will assess the safety and the efficacy of
    Kadcyla in patients with HER2-positive locally advanced or metastatic breast cancer who have
    received prior anti-HER2 and chemotherapy-based treatment. Patients in Cohort 1 will be
    drawn from the general patient population; Cohort 2 will include only asian patients.
    Patients in both cohorts will receive 3.6 mg/kg Kadcyla intravenously every 3 weeks until
    unacceptable toxicity, withdrawal of consent, or disease progression.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Cohort 1 Experimental Kadcyla (trastuzumab emtansine)
    Cohort 2 Experimental Kadcyla (trastuzumab emtansine)

    Eligibility Criteria

    Inclusion Criteria:

    - HER2-positive disease determined locally

    - Histologically or cytologically confirmed invasive breast cancer

    - Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced or
    metastatic setting must include both chemotherapy, alone or in combination with
    another agent, and an anti-HER2 agent, alone or in combination with another agent

    - Documented progression of incurable, unresectable, locally advanced, or metastatic
    breast cancer (mBC), defined by the investigator: progression must occur during or
    after most recent treatment for locally advanced/mBC or within 6 months of completing
    adjuvant therapy

    - Measurable and/or non-measurable disease

    - Left ventricular ejection fraction (LVEF) >/=50% by either echocardiogram (ECHO) or
    multiple-gated acquisition scan (MUGA)

    - Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2

    - Adequate organ function

    - Use of highly effective contraception as defined by the protocol

    - Cohort 2: only Asian patients will be enrolled

    Exclusion Criteria:

    - History of treatment with Kadcyla

    - Prior enrollment into a clinical study containing Kadcyla regardless of having
    received Kadcyla or not

    - Peripheral neuropathy of Grade >/= 3 per National Cancer Institute (NCI) common
    terminology criteria for adverse events (CTCAE) v. 4.0

    - History of other malignancy within the previous 5 years, except for appropriately
    treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine
    cancer, synchronous or previously diagnosed HER2-positive breast cancer

    - History of receiving any anti-cancer drug/biologic or investigational treatment
    within 21 days prior to first study treatment except hormone therapy, which can be
    given up to 7 days prior to first study treatment; recovery of treatment-related
    toxicity consistent with other eligibility criteria

    - History of exposure to cumulative doses of anthracyclines

    - History of radiation therapy within 14 days of first study treatment. The patient
    must have recovered from any resulting acute toxicity (to Grade </=1) prior to first
    study treatment.

    - Central nervous system (CNS)-only disease

    - Brain metastases which are symptomatic

    - History of a decrease in LVEF to < 40% or symptomatic congestive heart failure (CHF)
    with previous trastuzumab treatment

    - History of symptomatic CHF (New York Heart Association [NYHA] Classes II-IV) or
    serious cardiac arrhythmia requiring treatment

    - History of myocardial infarction or unstable angina within 6 months of first study
    treatment

    - Current dyspnea at rest due to complications of advanced malignancy or requirement
    for continuous oxygen therapy

    - Current severe, uncontrolled systemic disease (e.g., clinically significant
    cardiovascular, pulmonary, or metabolic disease)

    - Currently known active infection with HIV, hepatitis B virus, or hepatitis C virus

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Safety: incidence of adverse events

    Secondary Outcome Measures

    Progression-free survival according to response evaluation for solid tumors (RECIST) v.1.1

    Overall survival according to RECIST v.1.1

    Overall response rate according to RECIST v.1.1

    Clinical benefit rate according to RECIST v.1.1

    Duration of response according to RECIST v.1.1

    Time to response according to RECIST v.1.1

    Trial Keywords