Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Trastuzumab (AryoTrust) Versus Herceptin® in Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

July 9, 2016

Primary Completion Date

March 6, 2018

Study Completion Date

August 5, 2018

Conditions
Malignant Neoplasm of Breast
Interventions
DRUG

Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide

Trastuzumab (8 mg/kg IV loading dose at cycle 1, followed by 6 mg/kg at subsequent cycles) is given concomitantly with docetaxel (100 mg/m2 IV) for four 21-day cycles after four 14-day cycles of Doxorubicin (60 mg/m2 IV) plus cyclophosphamide (600 mg/m2 IV)

Trial Locations (19)

Unknown

Shafa Hospital, Ahvāz

Sheikh Mofid Clinic, Isfahan

Javadol Aemeh Clinic, Kerman

Park clinic, Kerman

Payandeh Clinic, Kermanshah

Imam Reza Hospital, Mashhad

Tohid Hospital, Sanandaj

Shahid Faqihi Hospital, Shiraz

Baqiatallah Hospital, Tehran

Booali Hospital, Tehran

Firoozgar Hospital, Tehran

Imam Khomeini hospital, Tehran

Jahad Daneshgahi Clinic, Tehran

Masood Clinic, Tehran

Mehrad Hospital, Tehran

Rasool Akram Hospital, Tehran

Toos Hospital, Tehran

Mortazavizadeh Clinic, Yazd

Aliebne Abitaleb Hospital, Zahedan

Sponsors
All Listed Sponsors
lead

AryoGen Pharmed Co.

INDUSTRY