A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in HER2+ Early Breast Cancer Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

503

Participants

Timeline

Start Date

February 19, 2018

Primary Completion Date

April 19, 2019

Study Completion Date

January 13, 2022

Conditions
HER2 Positive Breast Cancer
Interventions
DRUG

HD201

Loading dose of 8mg/kg in Cycle 1 and 6mg/kg in subsequent cycles.

DRUG

Herceptin

Loading dose of 8mg/kg in Cycle 1 and 6mg/kg in subsequent cycles.

DRUG

Docetaxel

75mg/m2 via i.v. infusion during cycles 1 to 4.

DRUG

Epirubicin

75 mg/m2 via i.v. infusion during cycles 5-8.

DRUG

Cyclophosphamide

500 mg/m2 via i.v. infusion during cycles 5-8.

Trial Locations (15)

1122

National Institute of Oncology, Budapest

4002

Complex Oncology Center, Plovdiv

4032

University of Debrecen, Debrecen

10138

East Tallinn Central Hospital, Tallinn

41009

Hospital Universitario Virgen Macarena, Seville

41124

Modena Hospital, Modena

46050

Beacon International Specialist Centre, Kuala Lumpur

50200

Maharaj Nakorn Chiang Mai Hospital, Chiang Mai

50586

Hospital Kuala Lumpur, Kuala Lumpur

61018

"GI V. T. Zaycev Institute General and Urgent Surgery of NAMS of Ukraine ", Kharkiv

92210

Centre René Huguenin (Institut Curie), Saint-Cloud

129515

"LLC Vitamed", Moscow

220013

Minsk Clinical Oncological Dispensary, Minsk

0179

S. Khechinashvili University Hospital, Tbilisi

95-060

Szpital Specjalistyczny Brzeziny, Brzeziny

Sponsors
All Listed Sponsors
lead

Prestige Biopharma Limited

INDUSTRY