A study in T-DM1 for use in patients with breast cancer after chemotherapy

A Study of Trastuzumab Emtansine (T-DM1) Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage Herceptin (HER)2-positive Breast Cancer

  • Breast Cancer
Trial Status:

Completed

This trial runs in
Countries
Trial Identifier:

NCT01196052

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial Summary

      This single-arm open-label study assessed the safety, feasibility, and efficacy of trastuzumab emtansine (T-DM1) after the completion of anthracycline-based adjuvant/neoadjuvant chemotherapy in patients with early HER2-positive breast cancer. Patients received T-DM1 3.6 mg/kg intravenously on Day 1 of each 3-week cycle, for up to 17 cycles.

      F. Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT01196052 Trial Identifier
      T-DM1 Treatments
      HER2 positive early breast cancer Condition
      Official Title

      A Study of Trastuzumab Emtansine (T-DM1) Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage Herceptin (HER)2-positive Breast Cancer

      Eligibility Criteria

      All Gender
      18 Years and older Age
      No Healthy Volunteers
      Inclusion Criteria
      • Adult patients ≥ 18 years of age.
      • Locally advanced, inflammatory, or early stage, unilateral, and histologically confirmed invasive breast cancer documented at a local laboratory (patients with inflammatory breast cancer must be able to have a core needle biopsy).
      • Herceptin (HER)2-positive tumor, confirmed by central testing using immunohistochemistry (IHC) and in situ hybridization (ISH) methods.
      • Willingness to receive anthracycline-based chemotherapy or have received doxorubicin/cyclophosphamide (AC) OR 5-fluorouracil (FU)/epirubicin/ cyclophosphamide (FEC) in a similar dose and schedule as described in the protocol as part of neoadjuvant or adjuvant treatment.
      • For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception or 2 effective forms of non-hormonal contraception by the patient and/or partner. Contraception use must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment. Male patients should use condoms for the duration of the study. Specific country requirements will be followed.
      • Negative results of serum pregnancy test for premenopausal women of reproductive capacity and for women < 12 months after menopause.
      • Patients may enroll before or after AC/FEC chemotherapy has completed.
      • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
      • Adequate hematologic, biochemistry, and cardiac assessments.
      Exclusion Criteria
      • Stage IV breast cancer or bilateral breast cancer.
      • Pregnant or breastfeeding women.
      • History of other malignancy within the previous 5 years, except contralateral breast cancer and ductal carcinoma in situ (DCIS)/lobular carcinoma in situ (LCIS), appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with outcome similar to those mentioned above.
      • Radiation therapy, immunotherapy, or biotherapy within 5 years before study enrollment; non-cardiotoxic chemotherapy for malignancy treated > 5 years before study enrollment is allowed. Patients receiving AC/FEC in a similar fashion to the study treatment prescribed for adjuvant or neoadjuvant treatment of breast cancer will be allowed to enroll in the study after the completion of their AC/FEC. No other prior history of cardiotoxic chemotherapy is allowed.
      • Active cardiac history.
      • Current chronic daily treatment with oral corticosteroids or equivalent.
      • Patients with severe dyspnea at rest or requiring supplementary oxygen therapy.
      • Active, unresolved infections at screening.
      • Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
      • Major surgery within 4 weeks before enrollment that is unrelated to the breast cancer.
      • Patients for whom concomitant radiotherapy + T-DM1 may be contraindicated yet radiation therapy is planned.
      • Known hypersensitivity to any of the study drugs or derivatives, including murine proteins.
      • Grade ≥ 2 peripheral neuropathy at Baseline.

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