An Open-Label Study of trastuzumab emtansine (T-DM1) compared to physician's choice in patients with HER2-Positive Metastatic Breast Cancer.
- Conditions
- HER2-Positive Metastatic Breast Cancer (MBC)MedDRA version: 14.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-000509-29-IT
- Lead Sponsor
- ROCHE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 735
• 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 regimen received as defined by the investigator; • Prior treatment with an anthracycline, trastuzumab, a taxane,lapatinib,and capecitabine; • Disease progression after at least 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 prior exposure to lapatinib and capecitabine.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 795
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 79
• 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 T DM1-containing study, regardless of whether the patient received prior T-DM1; • Brain metastases that are untreated or symptomatic, or require any radiation, surgery, or steroid therapy to control symptoms within 2 months of randomization.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - Objective response rate by independent review; - Overall survival (OS);Secondary Objective: • To evaluate the objective response rate (ORR) by investigator assessment • To evaluate the progression-free survival, duration of response, clinical benefit rate, and landmark survival rate (6-month survival rate and 1- year survival rate) of T-DM1 compared with treatment of physician's choice • To evaluate the safety of T-DM1 compared with treatment of physician's choice.;Primary end point(s): • Objective response rate by independent review; • Overall survival;;Timepoint(s) of evaluation of this end point: Final analysis of OS will take place about 36 months after FPI.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Objective response rate by investigator; • Progression-free survival(PFS); • Duration of objective response; • Clinical benefit rate; • Landmark survival rate.;Timepoint(s) of evaluation of this end point: Secondary Analysis will take place when 489 patients enrolled and followed for 9 months i.e. about 30 months from FPI.