An Open-Label Study of trastuzumab emtansine compared to physician's choice in patients with HER2-Positive Metastatic Breast Cancer.

Phase 1

Conditions: HER2-Positive Metastatic Breast Cancer (MBC)
MedDRA version: 18.0Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 18.0Level: LLTClassification code 10027475Term: Metastatic 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-BE

Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

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.