HER2-Positive Metastatic Breast Cancer (MBC) MedDRA version: 18.0 Level: PT Classification code 10065430 Term: HER-2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Progression-free survival (PFS) per investigator assessment - Overall survival (OS) ; Secondary Objective: • To evaluate the objective response rate (ORR) and landmark survival rate (6-month survival rate and 1-year survival rate) of trastuzumab emtansine compared with treatment of physician’s choice • To evaluate the safety of trastuzumab emtansine compared with treatment of physician’s choice. ; Primary end point(s): • Progression-free survival by investigator assessment • Overall survival ; Timepoint(s) of evaluation of this end point: • The primary PFS (by investigator assessment) analysis will be performed when approximately 324 PFS events have occurred, which is projected to be approximately 16 months from first patient enrolled in the trial (FPI). • The first OS interim analysis will be performed at the time of the primary PFS analysis (approximately 16 months from FPI); the second interim analysis will be performed when approximately 67% of the targeted deaths (492) have occurred (approximately 26 months from FPI). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Objective response rate by investigator • Duration of objective response • Landmark survival rate. ;Timepoint(s) of evaluation of this end point: After either PFS or OS (at any interim or final analysis) shows statistical significance, the secondary endpoints will be tested sequentially. | — |
Countries
Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Hungary, India, Israel, Italy, Korea, Republic of, Norway, Poland, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed