A Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Chinese Participants With HER2-Positive Early Breast Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

February 5, 2020

Primary Completion Date

December 13, 2021

Study Completion Date

February 8, 2026

Conditions
HER2-positive Early Breast Cancer
Interventions
DRUG

Pertuzumab IV

Pertuzumab will be administered as a fixed non-weight-based loading dose of 840-milligrams (mg) IV and then a 420-mg IV maintenance dose Q3W.

DRUG

Trastuzumab IV

Trastuzumab will be administered as an 8-milligram per kilogram of body weight (mg/kg) IV loading dose and then 6 mg/kg IV maintenance dose Q3W.

DRUG

Pertuzumab and Trastuzumab FDC SC

The pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) will be administered SC at a fixed non-weight-based dose. A loading dose of 1200 mg SC pertuzumab and 600 mg SC trastuzumab is then followed by a maintenance dose of 600 mg SC pertuzumab and 600 mg SC trastuzumab Q3W.

DRUG

Doxorubicin

Doxorubicin 60 milligrams per meter squared of body surface area (mg/m\^2) will be administered IV on Day 1 of each cycle of treatment (as part of AC Q3W) for Cycles 1-4.

DRUG

Cyclophosphamide

Cyclophosphamide 600 mg/m\^2 will be administered IV on Day 1 of each cycle of treatment (as part of AC Q3W) for Cycles 1-4.

DRUG

Docetaxel

Docetaxel 75 mg/m\^2 will be administered IV on Day 1 of Cycle 5. At the investigator's discretion the dose may be escalated to 100 mg/m\^2 IV for Cycles 6-8 (Q3W) provided no dose-limiting toxicity occurs.

PROCEDURE

Surgery

Participants in both cohorts are scheduled to undergo surgery after 8 cycles of neoadjuvant therapy. Participants may undergo breast-conserving surgery or mastectomy according to routine clinical practice.

RADIATION

Post-Operative Radiotherapy

If indicated, radiotherapy is given after chemotherapy and surgery, during adjuvant HER2-targeted therapy and hormone therapy (for hormone-receptor positive disease).

DRUG

Hormone Therapy

For hormone receptor positive breast cancer, tamoxifen or aromatase inhibitors will be allowed as adjuvant hormone therapy for postmenopausal participants and with ovarian suppression or ablation for premenopausal participants in countries where it has been registered for this indication. Its use must be consistent with the registered label. Hormone therapy is given after chemotherapy and surgery during adjuvant HER2-targeted therapy.

Trial Locations (18)

100044

Peking University People's Hospital, Beijing

100142

Beijing Cancer Hospital, Beijing

110016

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

130012

Jilin Cancer Hospital, Changchun

130021

The First Hospital of Jilin University, Changchun

150081

Harbin Medical University Cancer Hospital, Harbin

200025

Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai

200032

Fudan University Shanghai Cancer Center, Shanghai

210036

Jiangsu Province Hospital, Nanjing

250117

Shandong Cancer Hospital, Jinan

266003

The Affiliated Hospital of Medical College Qingdao University, Qingdao

310022

Zhejiang Cancer Hospital, Hangzhou

430023

Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan

430079

Hubei Cancer Hospital, Wuhan

510060

Sun Yet-sen University Cancer Center, Guangzhou

610041

West China Hospital, Sichuan University, Chengdu

710061

The First Affiliated Hospital of Xian Jiao Tong University, Xi'an

050035

Hebei Medical University Fourth Hospital, Shijiazhuang

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT04024462 - A Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Chinese Participants With HER2-Positive Early Breast Cancer | Biotech Hunter | Biotech Hunter