Pyrotinib, Trastuzumab, Pertuzumab and Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

216

Participants

Timeline

Start Date

May 30, 2020

Primary Completion Date

December 30, 2022

Study Completion Date

December 30, 2027

Conditions
Breast Cancer Invasive
Interventions
DRUG

Pyrotinib

Pyrotinib 400 mg taken orally everyday, every 3 weeks, for 4 cycles.

DRUG

Trastuzumab

"Trastuzumab IV infusion in 3-week cycles.~Neoadjuvant treatment: 8 milligrams per kilogram (mg/kg) loading dose for Cycle 1, followed by 6 mg/kg for Cycles 2-4.~Adjuvant treatment: 8 mg/kg loading dose, followed by 6 mg/kg for remaining cycles till completion of 1 year trastuzumab"

DRUG

Pertuzumab

"Pertuzumab IV infusion in 3-week cycles.~Neoadjuvant treatment: 840 milligrams (mg) loading dose for Cycle 1, followed by 420 mg for Cycles 2-4.~Adjuvant treatment: 840 mg loading dose, followed by 420mg for remaining cycles till completion of 1 year pertuzumab"

DRUG

Nab-paclitaxel

Nab-paclitaxel 100mg/m2 by intravenous (IV) infusion on day1, day8 and day15, every 3 weeks, for 4 cycles.

DRUG

EC chemotherapy

Epirubicin 90 mg/m2, and cyclophosphamide 600 mg/m2 by intravenous (IV) infusion every 3 weeks for 4 cycles (Cycles 5-8)

DRUG

Physician's choice

Physician decided chemotherapy for 0-4 cycles.

DRUG

T-DM1

T-DM1 IV infusion in 3-week cycles. 3.6 mg/kg by intravenous (IV) infusion every 3 weeks for 14 cycles

PROCEDURE

Surgery

All participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated.

Trial Locations (1)

200025

Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai

All Listed Sponsors
collaborator

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

lead

Shanghai Jiao Tong University School of Medicine

OTHER

NCT04398914 - Pyrotinib, Trastuzumab, Pertuzumab and Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer | Biotech Hunter | Biotech Hunter