EUCTR2011-000509-29-NOActive, not recruitingPhase 1
A Phase III randomized, multicenter, two-arm, open-label trial to evaluate the efficacy of trastuzumab emtansine compared with treatment of physician’s choice in patients with HER2-positive metastatic breast cancer who have received at least two prior regimens of HER2-directed therapy. - TH3RESA
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- F. Hoffmann-La Roche Ltd
- Enrollment
- 602
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Age = 18 years
- •Histologically or cytologically documented breast cancer
- •Metastatic or unresectable locally advanced/recurrent breast cancer
- •HER2-positive disease by prospective central laboratory confirmation
- •Disease progression on the last systemic anti-cancer regimen received as defined by the investigator unless they were intolerant
- •Prior treatment with trastuzumab, lapatinib, and a taxane in any setting
- •Disease progression after at least two regimens of HER2 directed therapy in the metastatic or unresectable locally advanced/recurrent breast cancer
- •A minimum of 6 weeks of prior trastuzumab
- •Patients must have had at least 6 weeks prior exposure to lapatinib.
- •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 540
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
Exclusion Criteria
- •Chemotherapy = 21 days before first study treatment
- •Trastuzumab = 21 days before first study treatment
- •Lapatinib = 14 days before first study treatment
- •Prior enrollment in a trastuzumab emtansine-containing study, regardless of whether the patient received prior trastuzumab emtansine
- •Brain metastases that are untreated or symptomatic, or require any radiation, surgery, or corticosteroid therapy to control symptoms within 1 month of randomization.
Investigators
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