A Study to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel Versus Placebo + Trastuzumab + Docetaxel in Previously Untreated Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

243

Participants

Timeline

Start Date

September 13, 2016

Primary Completion Date

June 27, 2018

Study Completion Date

January 22, 2021

Conditions
Breast Cancer
Interventions
DRUG

Docetaxel

Docetaxel (75-mg/m\^2) was administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.

DRUG

Pertuzumab

Pertuzumab (840-mg loading dose for Cycle 1, followed by 420 mg for subsequent cycles) was administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.

DRUG

Placebo

Placebo matched to pertuzumab was administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.

DRUG

Trastuzumab

Trastuzumab (8-mg/kg loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles) was administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.

Trial Locations (15)

100021

CHINESE ACADEMY OF MEDICAL SCIENCE; CANCER INST. & HOSPITAL; Medical ward, Beijing

100142

Beijing Cancer Hospital, Beijing

100853

Chinese PLA General Hospital, Beijing

110001

First Hospital of China Medical University, Shenyang

110016

The 900th Hospital of PLA joint service support force, Fuzhou

110042

Liaoning cancer Hospital & Institute, Shenyang

130021

the First Hospital of Jilin University, Changchun

150081

Harbin Medical University Cancer Hospital, Harbin

200120

Fudan University Shanghai Cancer Center, Shanghai

210029

Jiangsu province hospital; surgery on galactophore, Nanjing

211100

Jiangsu Cancer Hospital, Nanjing

213003

Changzhou First People's Hospital, Changzhou

310022

Zhejiang Cancer Hospital, Zhejiang

510080

Guangdong General Hospital, Guangzhou

610041

West China Hospital, Sichuan University, Chengdu

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02896855 - A Study to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel Versus Placebo + Trastuzumab + Docetaxel in Previously Untreated Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter