Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments docetaxel, paclitaxel, pertuzumab, pertuzumab-placebo, trastuzumab [herceptin], trastuzumab emtansine
Phase phase 3
Targets HER, HER2
Sponsor Hoffmann-La Roche
Collaborator Genentech, Inc.
Start date July 2010
End date February 2016
Trial size 1095 participants
Trial identifier NCT01120184, BO22589

Summary

This randomized, 3-arm, multicentre, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in patients with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Patients will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
docetaxel
75 mg/m2 or 100 mg/m2 intravenously every 3 weeks for a minimum of 6 cycles.
paclitaxel
80 mg/m2 intravenously weekly for a minimum of 18 weeks
trastuzumab [herceptin]
trastuzumab [Herceptin] doses when administered with docetaxel: 8 mg/kg intravenously on cycle 1 followed by 6 mg/kg every 3 weeks in subsequent cycles or trastuzumab (Herceptin) doses when administered with paclitaxel: 4 mg/kg intravenously on day 1 of cycle 1 followed by 2 mg/kg weekly starting on day 8 of cycle 1.
(Experimental)
pertuzumab
840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles
pertuzumab-placebo
840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles
trastuzumab emtansine
3.6 mg/kg intravenously every 3 weeks
(Experimental)
pertuzumab
840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles
pertuzumab-placebo
840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles
trastuzumab emtansine
3.6 mg/kg intravenously every 3 weeks

Primary Outcomes

Measure
Progression Free Survival (PFS) based on tumor assessments performed by an Independent Review Facility (IRF)
time frame: Up to approximately 48 months after study start
Incidence of adverse events (AEs)
time frame: Up to approximately 78 months after study start

Secondary Outcomes

Measure
Overall Survival (OS) truncated at 2 years
time frame: Up to approximately 48 months after study start
1-year survival rate
time frame: From baseline to 1 year
Overall Survival (OS) rate
time frame: Up to approximately 78 months after study start
Overall or objective response rate
time frame: Up to approximately 48 months after study start
Duration of response
time frame: Up to approximately 48 months after study start
Time-to-Treatment Failure as assessed by IRF
time frame: Up to approximately 48 months after study start
Clinical benefit rate
time frame: Up to approximately 48 months after study start

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients >/=18 years of age - HER2-positive breast cancer - Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and be a candidate for chemotherapy. Patients with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent. - Patients must have measurable and/or non-measurable disease which must be evaluable per RECIST 1.1 - ECOG Performance Status 0 or 1 - Adequate organ function as determined by laboratory results Exclusion Criteria: - History of prior (or any) chemotherapy for metastatic breast cancer or recurrent locally advanced disease - An interval of <6 months from the last dose of vinca-alkaloid or taxane cytotoxic chemotherapy until the time of metastatic diagnosis - Hormone therapy <7 days prior to randomization - Trastuzumab therapy and/or lapatinib (neo- or adjuvant setting) <21 days prior to randomization - Prior trastuzumab emtansine or pertuzumab therapy

Additional Information

Official title A Study of Trastuzumab-DM1 Plus Pertuzumab Versus Trastuzumab [Herceptin] Plus a Taxane in Patients With Metastatic Breast Cancer
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.