Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer to Evaluate Treatment With Trastuzumab Plus (+) Pertuzumab + Docetaxel Compared With Trastuzumab + Placebo + Docetaxel

PHASE3CompletedINTERVENTIONAL
Enrollment

329

Participants

Timeline

Start Date

March 14, 2016

Primary Completion Date

October 23, 2017

Study Completion Date

March 14, 2022

Conditions
Breast Cancer
Interventions
DRUG

FEC Chemotherapy

Fluorouracil 500-600 milligrams per square meter (mg/m2), epirubicin 90-120 mg/m2, and cyclophosphamide 500-600 mg/m2 by intravenous (IV) infusion every 3 weeks for three cycles (Cycles 5-7). FEC chemotherapeutic agents will be administered following surgery on Day 1 of each specified cycle.

PROCEDURE

Surgery

All participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated.

DRUG

Docetaxel

Docetaxel IV infusion in 3-week cycles. Neoadjuvant treatment: 75 mg/m2 for Cycles 1-4.

DRUG

Pertuzumab

Pertuzumab IV infusion in 3-week cycles. Prior to surgery (neoadjuvant treatment): 840 milligrams (mg) loading dose for Cycle 1, followed by 420 mg for Cycles 2-4. After surgery and 3 cycles of FEC chemotherapy (adjuvant treatment): 840 mg loading dose for Cycle 8, followed by 420 mg for Cycles 9-20)

DRUG

Placebo

Placebo by IV infusion in 3-week cycles as neoadjuvant treatment (Cycles 1-4)and as adjuvant treatment (Cycles 8-20)

DRUG

Trastuzumab

Trastuzumab IV infusion in 3-week cycles. Neoadjuvant treatment: 8 milligrams per kilogram (mg/kg) loading dose for Cycle 1, followed by 6 mg/kg for Cycles 2-4. Adjuvant treatment: 8 mg/kg loading dose for Cycle 8, followed by 6 mg/kg for Cycles 9-20.

Trial Locations (23)

104

Mackay Memorial Hospital; Dept of Surgery, Taipei

110

Taipei Medical University Hospital, Taipei

404

China Medical University Hospital; Surgery, Taichung

10220

Bhumibol Adulyadej Hospital; Medicine, Bangkok

16499

Ajou University Medical Center, Gyeonggi-do

23561

Taipei Medical University ?Shuang Ho Hospital, New Taipei City

40002

Srinagarind Hospital, Khon Kaen University; Surgery, Khon Kaen

41404

Kyungpook National University Medical Center, Daegu

90110

Songklanagarind Hospital; Department of Surgery, Songkhla

100071

The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA), Beijing

130021

the First Hospital of Jilin University, Changchun

132013

Jilin Cancer Hospital, Changchun

150081

Harbin Medical University Cancer Hospital, Harbin

200025

Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital), Shanghai

200120

Fudan University Shanghai Cancer Center, Shanghai

210008

Jiangsu Province Hospital, Nanjing

250117

Shandong Cancer Hospital, Jinan

310022

Zhejiang Cancer Hospital, Zhejiang

350001

Fujian Medical University Union Hospital, Fuzhou

450008

Henan Cancer Hospital, Zhengzhou

510080

Guangdong General Hospital, Guangzhou

510663

Sun Yet-sen University Cancer Center, Guangzhou

08308

Korea University Guro Hospital, Seoul

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02586025 - Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer to Evaluate Treatment With Trastuzumab Plus (+) Pertuzumab + Docetaxel Compared With Trastuzumab + Placebo + Docetaxel | Biotech Hunter | Biotech Hunter