A Study to Investigate the Tolerability of Subcutaneous (SC) Trastuzumab Administration in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Early Breast Cancer (eBC) Using Either a Single-Use Injection Device or Manual Administration

PHASE3CompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

July 18, 2014

Primary Completion Date

July 12, 2018

Study Completion Date

July 12, 2018

Conditions
Breast Cancer
Interventions
DRUG

Trastuzumab

Trastuzumab IV or SC will be administered as described.

DRUG

Paclitaxel

Paclitaxel will be administered in accordance with local hospital practice.

DRUG

Docetaxel

Docetaxel will be administered in accordance with local hospital practice.

Trial Locations (7)

223040

State Inst N.N. Alexandrov Republican Scientific & Practical Centre of Oncology & Medical Radiology, A/g Lesnoy, Minsk Region

224027

"Healthcare Institution Brest Regional Oncologic Dispensary", Brest

BU-220013

Minsk City Clinical Oncologic Dispensary, Minsk

BU-210603

Vitebsk Regional Clinical Oncology Dispensary, Vitebsk

050022

Kazakh Scientific Research Institution Of Oncology and Radiology; Chemotherapy department, Almaty

050054

Almaty Cancer Hospital; Chemotherapy department, Almaty

010000

Oncology centre of Astana; Chemotherapy department, Astana

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02194166 - A Study to Investigate the Tolerability of Subcutaneous (SC) Trastuzumab Administration in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Early Breast Cancer (eBC) Using Either a Single-Use Injection Device or Manual Administration | Biotech Hunter | Biotech Hunter