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Clinical Trials/CTRI/2012/07/002804
CTRI/2012/07/002804Active, not recruitingPhase 3

A PHASE III randomized, multicenter, two-arm, open-label trial to evaluate the efficacy of T-DM1 compared with treatment of physicianâ??s choice in patients with HER2-positive metastatic breast cancer who have received at least two prior regimens of HER2 directed therapy - THERESA

Genentech Inc0 sites0 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 3
Status
Active, not recruiting
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • •Signed study-specific Informed Consent Form(s)
  • •Age >= 18 years
  • •Histologically or cytologically documented breast cancer
  • •Metastatic or unresectable locally advanced/recurrent breast cancer
  • •HER2-positive disease documented as ISH-positive and/or 3+ by IHC on previously collected tumor tissue and prospectively confirmed by Sponsor-designated central laboratory prior to study enrolment
  • •Tumor blocks or 11 unstained slides available for confirmatory central laboratory HER2 testing and exploratory biomarker analyses Both IHC and ISH assays will be performed; however, only one positive result is required for eligibility.
  • •Disease progression on the last regimen received as defined by the investigator
  • •Prior treatment with an anthracycline, trastuzumab, a taxane, lapatinib, and capecitabine in the neoadjuvant, adjuvant, locally advanced, or recurrent/metastatic setting and documented disease progression (by investigator assessment) after at least two regimens of HER2-directed therapy in the metastatic or unresectable locally advanced/recurrent setting
  • •A minimum of 6 weeks of prior trastuzumab for the treatment of metastatic or unresectable locally advanced/recurrent disease is required. Trastuzumab must have been administered as six consecutive weekly doses or as two consecutive doses on an every-3-week schedule.
  • •Patients must have had at least 6 weeks of prior exposure in the metastatic (or unresectable locally advanced/recurrent) setting to lapatinib and capecitabine (given together or separately) unless they were intolerant of lapatinib and/or capecitabine.
  • •Intolerance is defined as any treatment-related Grade 4 adverse event, or any treatment-related Grade 2 or 3 adverse event that is unacceptable to the patient and persists despite standard countermeasures. The reason for intolerance will be fully documented.
  • •Patients who were found to be intolerant to lapatinib can be considered eligible if they experienced disease progression during a single trastuzumab-based regimen in the metastatic (or unresectable locally advanced/recurrent) setting.
  • •For patients with hormone-receptorâ??positive disease, disease progression in any setting on prior hormonal therapy
  • •Adequate organ function, as evidenced by the following laboratory results:
  • •Absolute neutrophil count > 1500 cells/mm3
  • •Platelet count > 100,000 cells/mm3
  • •Hemoglobin > 9.0 g/dL
  • •Patients are allowed to receive transfused red blood cells to achieve this level.
  • •Total bilirubin <= 1.5 upper limit of normal (ULN) except in patients with previously documented Gilbertâ??s syndrome in which case total bilirubin <= 3 mg/dL
  • •SGOT (AST) and SGPT (ALT) <= 2.5 Ã? the ULN
  • •Alkaline phosphatase <= 2.5 Ã? the ULN
  • •Patients with hepatic and/or bone metastases:
  • •alkaline phosphatase <= 5 Ã? the ULN
  • •Serum creatinine < 1.5 Ã? the ULN
  • •International normalized ratio (INR) < 1.5 Ã? the ULN
  • •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (see Appendix B)
  • •LVEF >= 50% by either ECHO or MUGA
  • •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including completion of PRO measures
  • •Negative results of serum p

Exclusion Criteria

  • •Patients who meet any of the following criteria will be excluded from study entry:
  • •a. Cancer-Related Criteria
  • •Chemotherapy <= 21 days before first study treatment
  • •Trastuzumab <= 21 days before first study treatment
  • •Lapatinib <= 14 days before first study treatment
  • •Hormone therapy <= 7 days before first study treatment
  • •Investigational therapy or any other therapy <= 28 days before first study treatment
  • •Prior enrollment in a T-DM1â??containing study, regardless of whether the patient received prior T-DM1
  • •Previous radiotherapy for the treatment of unresectable, locally advanced/recurrent or metastatic breast cancer is not allowed if: The last fraction of radiotherapy has been administered within 14 days prior to randomization. More than 25% of marrow-bearing bone has been irradiated. The patient has not recovered from any resulting acute toxicity (to Grade <= 1) prior to randomization.
  • •Brain metastases that are untreated or symptomatic, or require any radiation, surgery, or steroid therapy to control symptoms from brain metastases within 2 months of randomization
  • •History of intolerance (including Grade 3 or 4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins
  • •History of exposure to the following cumulative doses of anthracyclines:
  • •Doxorubicin or liposomal doxorubicin 500 mg/m2
  • •Epirubicin 900 mg/m2
  • •Mitoxantrone 120 mg/m2
  • •If another anthracycline, or more than one anthracycline, has been used, the cumulative dose must not exceed the equivalent of 500 mg/m2 doxorubicin.
  • •Current peripheral neuropathy of Grade >= 3 per the NCI CTCAE, v4.0
  • •History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those mentioned above
  • •b. Cardiopulmonary Function Criteria
  • •Current unstable ventricular arrhythmia requiring treatment
  • •History of symptomatic CHF (New York Heart Association [NYHA] Classes IIâ??IV)
  • •History of myocardial infarction or unstable angina within 6 months of enrollment
  • •History of a decrease in LVEF to 40% or symptomatic CHF with previous trastuzumab treatment
  • •Severe dyspnea at rest due to complications of advanced malignancy or requiring current continuous oxygen therapy
  • •c. General Criteria
  • •Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
  • •Major surgical procedure or significant traumatic injury within 28 days before enrollment or anticipation of the need for major surgery during the course of study treatment
  • •Current pregnancy or lactation
  • •Current known active infection with HIV, hepatitis B, and/or hepatitis C virus
  • •For patients who are known carriers of hepatitis B virus (HBV), active hepatitis B infection must be ruled out based on negative serologic testing and/or determination of HBV DNA viral load per local guidelines.
  • •Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol

Investigators

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