Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive and Estrogen Receptor/Progesterone Receptor Negative Breast Cancer to Evaluate the Efficiency and Safety of Treatment With Trastuzumab Plus (+) QL1209/Pertuzumab + Docetaxel.

PHASE3CompletedINTERVENTIONAL
Enrollment

517

Participants

Timeline

Start Date

November 23, 2020

Primary Completion Date

August 22, 2022

Study Completion Date

October 24, 2023

Conditions
Breast Cancer
Interventions
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.

DRUG

QL1209

QL1209 IV infusion in 3-week cycles. Prior to surgery (neoadjuvant treatment): 840 milligrams (mg) loading dose for Cycle 1, followed by 420 mg for Cycles 2-4.

DRUG

Pertuzumab

Pertuzumab IV infusion in 3-week cycles. Prior to surgery (neoadjuvant treatment): 840 milligrams (mg) loading dose for Cycle 1, followed by 420 mg for Cycles 2-4.

DRUG

Docetaxel

Docetaxel IV infusion in 3-week cycles. Neoadjuvant treatment: 75 mg/m2 for Cycles 1-4

PROCEDURE

surgery

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

Trial Locations (2)

300171

Tianjin Medical University Cancer Institution & Hospital, Tianjin

2000 32

Fudan University Cancer Hospital, Shanghai

All Listed Sponsors
lead

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

NCT04629846 - Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive and Estrogen Receptor/Progesterone Receptor Negative Breast Cancer to Evaluate the Efficiency and Safety of Treatment With Trastuzumab Plus (+) QL1209/Pertuzumab + Docetaxel. | Biotech Hunter | Biotech Hunter