Safety Study of Pertuzumab (in Combination With Trastuzumab and Docetaxel) in Indian Participants With Breast Cancer

PHASE4CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

August 17, 2015

Primary Completion Date

September 26, 2018

Study Completion Date

September 26, 2018

Conditions
Breast Cancer
Interventions
DRUG

Docetaxel

Participants will receive docetaxel in line with locally approved Prescribing Information. After Cycle 6 (cycle length = 21 days), continuation of docetaxel treatment will be at the discretion of the investigator. Docetaxel will be administered after pertuzumab and trastuzumab.

DRUG

Pertuzumab

Participants will receive pertuzumab at an initial dose of 840 milligrams (mg) as a 60-minute intravenous infusion on Cycle 1 Day 1 (cycle length = 21 days), followed by every 3 weeks at a dose of 420 mg as a 30 to 60-minute intravenous infusion until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.

DRUG

Trastuzumab

Participants will receive trastuzumab at an initial dose of 8 milligrams per kilogram (mg/kg) as a 90-minute intravenous infusion on Cycle 1 Day 1 (cycle length = 21 days), followed by every 3 weeks at a dose of 6 mg/kg as a 30 to 90-minute intravenous infusion until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.

Trial Locations (9)

110092

MAX Balaji Hospital, Delhi

400012

Tata Memorial Hospital; Dept of Medical Oncology, Mumbai

400053

Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute, Mumbai

411001

Jehangir Clinical Development Centre Pvt. Ltd; Cancer Research Room, Pune

500034

Indo-American Cancer Hospital & Research Center, Hyderabad

560054

M S Ramaiah Memorial Hospital, Bangalore

632004

Christian Medical College & Hospital; Medicine, Vellore

700156

TATA Medical Centre; Medical Oncology, Kolkata

110 085

Rajiv Gandhi Cancer Institute & Research Center, New Delhi

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02445586 - Safety Study of Pertuzumab (in Combination With Trastuzumab and Docetaxel) in Indian Participants With Breast Cancer | Biotech Hunter | Biotech Hunter