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

  • Cancer
  • Breast Cancer
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:


This trial runs in
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Croatia
  • Denmark
  • Dominican Republic
  • Ecuador
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Guatemala
  • Hong Kong
  • Hungary
  • iceland
  • indonesia
  • Ireland
  • Italy
  • Luxembourg
  • Mexico
  • Netherlands
  • Norway
  • Panama
  • Peru
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • Turkey
  • United Arab Emirates
  • United Kingdom
  • United States
  • venezuela
Trial Identifier:

NCT01702571 2012-001628-37 MO28231

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      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.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT01702571, MO28231, 2012-001628-37 Trial Identifier
      Trastuzumab Emtansine Treatments
      Breast Cancer Condition
      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

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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, LABC, or mBC, defined by the investigator: progression must occur during or after most recent treatment for LABC/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
      Exclusion Criteria
      • History of treatment with trastuzumab emtansine
      • Prior enrollment into a clinical study containing trastuzumab emtansine regardless of having received trastuzumab emtansine 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 participant must have recovered from any resulting acute toxicity (to Grade </=1) prior to first study treatment.
      • Metastatic central nervous system (CNS) disease only
      • Brain metastases which are symptomatic
      • History of a decrease in LVEF to less than (<) 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 (clinically significant cardiovascular, pulmonary, or metabolic disease)
      • Pregnancy or lactation
      • Currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
      • History of intolerance (such as Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins or any component of the product

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