Halozyme Therapeutics Inc (HALO)

[rod5247]

Phase IIIb Study to Evaluate the Safety and Tolerability of Herceptin SC With Perjeta and Docetaxel in Patients With HER2-positive Advanced Breast Cancer

Condition:
Breast Cancer

Interventions:
Drug: Docetaxel; Drug: pertuzumab [Perjeta]; Drug: trastuzumab [Herceptin]

Study Type:
Interventional

Phase:
Phase 3

Sponsor:
Hoffmann-La Roche

Funder Type:
Industry

Study Design:
Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Primary Purpose: Treatment; Masking: Open Label

Outcome Measures:
Incidence of adverse events (AEs); Incidence and severity of adverse events Grade >/= 3, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0; Incidence of cardiac events (composite outcome measure): congestive heart failure (CHF) and cardiac death; Progression-free survival, tumor assessments according to RECIST v1.1; Overall survival; Objective response rate, defined as a complete response (CR) or a partial response (PR); Incidence of anti-Herceptin, anti-rHuPH20 antibodies

Number Enrolled:
400

Gender:
Female

Age Groups:
Adult / Senior

NCT Number:
NCT02402712

Other IDs:
BO29159, 2014-001458-40

Title Acronym:


Study Start:
May 2015

Primary Completion:
November 2018

Study Completion:
November 2018

First Received:
March 23, 2015

Last Updated:
March 25, 2015

Last Verified:
March 2015

Results First Received:
No Study Results Posted