This trial is active, not recruiting.

Condition metastatic breast cancer
Treatments trastuzumab + docetaxel, trastuzumab emtansine
Phase phase 3
Sponsor Hoffmann-La Roche
Start date July 2014
End date October 2017
Trial size 49 participants
Trial identifier NCT02144012, YO28405


This is a Phase III, randomized, multicenter, multinational, two-arm, open-label clinical trial to investigate a first-line treatment of patients with HER2-positive metastatic breast cancer. The study will enroll patients with HER2-positive, unresectable, locally advanced breast cancer (BC) if they have recurrent disease or progressive disease (PD) despite primary multimodality therapy, and/or metastatic BC if they have not received prior chemotherapy for their metastatic disease. Eligible patients at up to approximately 40 sites in the Asia-Pacific region will be randomized in a 2:1 ratio to receive trastuzumab emtansine (Arm A) and will receive trastuzumab plus docetaxel (Arm B). All study drugs will be administered at in-clinic visits occurring every three weeks during the treatment phase. Trastuzumab plus docetaxel was chosen as the comparator in the control group (Arm B), as it represents a common first-line treatment option used in this patient population in China and other Asia-Pacific countries.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
trastuzumab emtansine
trastuzumab emtansine 3.6 mg/kg intravenous (IV) over 30-90 minutes every 3 weeks (Q3W)
(Active Comparator)
trastuzumab + docetaxel
For the first cycle, trastuzumab 8 mg/kg IV plus docetaxel at either 75 mg/m2 or 100 mg/m2 IV. For the subsequent cycles, trastuzumab 6 mg/kg IV plus docetaxel 75 mg/m2 or 100 mg/m2 IV Q3W

Primary Outcomes

Progression-free survival, defined as the time from randomization to the first occurrence of disease progression (with the use of RECIST v1.1) or death from any cause, whichever occurs first, on the basis of investigator assessments
time frame: Up to 66 months
Safety: Incidence of adverse events (AEs)
time frame: Up to 66 months

Secondary Outcomes

Overall survival (OS), defined as the time from the date of randomization to the date of death from any cause
time frame: Up to 66 months
One-year survival rate, Kaplan-Meier estimates
time frame: Up to 66 months
OS truncated at 2 years, defined as the time from the date of randomization to the date of death from any cause, with deaths occurring beyond 2 years after the patient's randomization date censored at 2 years
time frame: Up to 66 months
Objective response rate (ORR), defined as partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of RECIST v1.1
time frame: Up to 66 months
Duration of response (DOR), defined as the time from the date of initial confirmed PR or CR to the date of disease progression or death within the study
time frame: Up to 66 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age >/= 18 years - HER2-positive disease, as defined by an immunohistochemistry test score of 3+ and/or in situ hybridization positivity, prospectively confirmed by a Sponsor-designated central laboratory prior to enrollment - Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease appropriate for chemotherapy - Patients must have measurable and/or non-measurable disease that is evaluable per the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1 - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Adequate organ function - For women of childbearing potential and men with partners of childbearing potential, agreement by the patient and/or partner to use two adequate non-hormonal forms of contraception during treatment and for at least 6 months after the last dose of study drug Exclusion Criteria: - Pregnancy or lactation - Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; bone fractures, except bone fractures because of disease under study) - Currently known active infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) - Major surgical procedure or significant traumatic injury within approximately 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment - Current peripheral neuropathy Grade >/= 2 per National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE, v4.0) - History of systemic anti-cancer therapy after the diagnosis of MBC or for recurrent locally advanced disease, with the exception of prior hormonal regimens for recurrent locally advanced disease or MBC - An interval of < 12 months after the last dose of vinca alkaloid or taxane chemotherapy (i.e., for treatment of early stage, non-metastatic disease) - Hormonal therapy < 7 days prior to randomization - Trastuzumab < 21 days prior to randomization - Lapatinib 10 mg/day methylprednisone equivalent) - History of intolerance (including Grade 3 or 4 infusion reaction) or hypersensitivity to trastuzumab, murine proteins, docetaxel or paclitaxel - Known hypersensitivity any of the study drugs, including excipients, or any drugs formulated in polysorbate 80

Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.