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Clinical Trials/EUCTR2008-002819-40-HU
EUCTR2008-002819-40-HUActive, not recruitingNot Applicable

A randomized, multicenter, Phase II study of the efficacy and safety of trastuzumab-MCC-DM1 vs. trastuzumab (Herceptin®) and docetaxel (Taxotere®) in patients with metastatic HER2-positive breast cancer who have not received prior chemotherapy for metastatic disease

F Hoffmann-La Roche Ltd0 sites120 target enrollmentStarted: October 20, 2008Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
120
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •a. Disease-Specific Criteria
  • •1. Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease, and a candidate for chemotherapy. Patients with locally advanced disease must have recurrent or progressive disease after failing initial attempts at local control. The disease must be considered to be unresectable.
  • •2. HER2-positive (IHC 3+ or gene-amplified by FISH-positive) based on local laboratory assay results
  • •3. No prior chemotherapy for their MBC (hormonal therapy is allowed.)
  • •4. Measurable disease per modified RECIST
  • •Patients should have at least one target lesion =2 cm on conventional CT scan or = 1 cm on a spiral CT scan.
  • •5. Tumor blocks or 11 unstained slides available for confirmatory central laboratory HER2 testing
  • •b. General Criteria
  • •6. Age =18 years
  • •7. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
  • •8. Adequate organ function, evidenced by the following laboratory results within approximately 21 days prior to randomization:
  • •Absolute neutrophil count >1500 cells/mm[3]
  • •Platelet count > 100,000 cells/mm[3]
  • •Hemoglobin > 9.0 g/dL
  • •Patients are allowed to be transfused with red blood cells to obtain this level.
  • •Total bilirubin = 1.5 x the upper limit of normal (ULN)
  • •SGOT (AST) and/or SGPT (ALT), and alkaline phosphatase = 2.5 ×ULN, with the following exception:
  • •Patients with bone metastases: alkaline phosphatase = 5 x ULN
  • •Serum creatinine < 1.5 × ULN
  • •International normalized ratio (INR) and activated partial thromboplastin time (aPTT) < 1.5 ×ULN (unless on therapeutic anticoagulation or due to a lupus anticoagulant)
  • •For women of childbearing potential and men with partners of childerbearing potential, agreement to use a highly effective, non-hormonal form of contraception or two 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 whose partners are pregnant should use condoms for the duration of the study.
  • •Specific country requirements will be followed (e.g., in the United Kingdom, women of childbearing potential and male subjects and their partners of childbearing potential must use two methods of contraception [one of which must be a barrier method] for the duration of the study).
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •a. Cancer-Related Criteria
  • •1. History of any chemotherapy for MBC
  • •Prior hormonal therapy is allowed.
  • •2. An interval of < 6 months from the completion of cytotoxic chemotherapy (excluding hormonal therapy) in the neo-adjuvant or adjuvant setting until the time of treatment on study for metastatic disease.
  • •3. Trastuzumab = 21 days prior to randomization
  • •4. Hormone therapy < 7 days prior to randomization
  • •5. Current peripheral neuropathy of Grade =3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0
  • •6. History of other malignancy within the last 5 years, except for appropiately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those previously mentioned.
  • •7. Previous radiotherapy for the treatment of unresectable, locally advanced or metastatic breast cancer is not allowed if:
  • •More than 25% of marrow-bearing bone has been irradiated.
  • •The last fraction of radiotherapy has been administered within approximately 3 weeks prior to randomization.
  • •8. Brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery, or other therapy to control symptoms from brain metastases within 2 months prior to randomization.
  • •CT or magnetic resonance imaging (MRI) scan of the brain is mandatory (within approximately 28 days prior to randomization) in cases of clinical suspicion of brain metastases or in a patient with any prior history of brain metastases.
  • •9. History of exposure to the following cumulative doses of anthracyclines:
  • •Doxorubicin or liposomal doxorubicin > 500 mg/m[2]
  • •Epirubicin > 900 mg/m[2]
  • •Mitoxantrone > 120mg/m[2] and idarubicin > 90 mg/m[2]
  • •If another anthracycline or more than 1 anthracycline has been used, then the cumulative dose must not exceed the equivalent of 500 mg/m[2] of doxorubicin.
  • •b. Cardiopulmonary Function
  • •10. Current unstable angina
  • •11. History of symptomatic congestive heart failure (CHF; New York Heart Association [NYHA] classes II-IV), or ventricular arrhythmia requiring treatment
  • •12. History of myocardial infarction within 6 months prior to randomization
  • •13. LVEF below 50% within approximately 28 days prior to randomization
  • •14. History of a decrease in LVEF to < 40% or symptomatic CHF with previous adjuvant trastuzumab treatment
  • •15. Cardiac troponin I = 0.2 ng/mL within approximately 28 days prior to randomization
  • •16. Severe dyspnea at rest because of complications of advanced malignancy or requiring current continuous oxygen therapy
  • •General Criteria
  • •17. Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures)
  • •18. Major surgical procedure or significant traumatic injury within approximately 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
  • •19. Current pregnancy or lactation
  • •20. History of receiving any investigational treatment within approximately 28 days prior to randomization
  • •21. Current known infection with HIV, active hepatitis B and/or hepatitis C virus
  • •22. History of intolerance (including Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab, murine proteins, or docetaxel
  • •23. Known hypersensitivity to any of the study drugs, including the excipients, or any drugs formulated in polysorbate 80
  • •24. Assessed by the investigator to be unab

Investigators

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