Safety and Efficacy of Trastuzumab as Part of Breast Cancer Treatment Regimen

PHASE4CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

August 18, 2015

Primary Completion Date

June 24, 2021

Study Completion Date

June 24, 2021

Conditions
Breast Cancer
Interventions
DRUG

Carboplatin

TCH regimen: Carboplatin dose = Target Area Under Curve (AUC) (6 milligrams\*milliliter/minute \[mg\*mL/min\]) multiplied by (Glomerular Filtration Rate \[GFR\] + 25). Carboplatin will be administered as IV bolus every 3 weeks for 6 cycles (Cycles 1 to 6).

DRUG

Cyclophosphamide

AC-TH regimen: Cyclophosphamide 600 mg/m\^2 IV bolus every 3 weeks for 4 cycles (Cycles 1 to 4).

DRUG

Docetaxel

AC-TH regimen: Docetaxel 100 mg/m\^2 IV infusion every 3 weeks for 4 cycles (Cycles 5 to 8). TCH regimen: Docetaxel 75 mg/m\^2 IV bolus every 3 weeks for 6 cycles (Cycles 1 to 6).

DRUG

Doxorubicin

Participants will receive Doxorubicin 60 mg/m\^2 administered as I.V. bolus injection over 5 to 15 minute every 3 weeks for 4 cycles for AC-TH regimen.

DRUG

Paclitaxel

AC-TH regimen: Paclitaxel 175 mg/m\^2 IV infusion every 3 weeks for 4 cycles (Cycles 5 to 8).

DRUG

Trastuzumab

AC-TH regimen: For weekly administration, 4 milligrams per kilograms (mg/kg) loading dose on Day 1 of Cycle 5, followed by 2 mg/kg on Day 8 of Cycle 5 and 2 mg/kg every week for 4 cycles (up to Cycle 8). For 3 weekly administration, 8 mg/kg loading dose on Day 1 of Cycle 5, followed by 6 mg/kg every 3 for 4 cycles (up to Cycle 8). From Day 1 of Cycle 9, 6 mg/kg will be administered every 3 weeks up to Cycle 22. TCH regimen: For weekly administration, 4 mg/kg loading dose followed by 2 mg/kg weekly from Cycles 1 to Cycle 6. For 3 weekly administration, 8 mg/kg loading dose followed 6 mg/kg every 3 weeks from Cycles 1 to 6. From Cycle 7, 6 mg/kg every 3 weeks up to Cycle 18. All administrations will be intravenous (IV) infusion.

Trial Locations (6)

110085

Rajiv Gandhi Cancer Institute & Research Center, New Delhi

110092

MAX Balaji Hospital, Delhi

411001

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

500082

Yashoda Hospital, Hyderabad

560017

Manipal Hospital; Department of Oncology, Bangalore

620008

Dr. GVN Cancer Institute; Medical Oncology, Trichy

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02419742 - Safety and Efficacy of Trastuzumab as Part of Breast Cancer Treatment Regimen | Biotech Hunter | Biotech Hunter