A Study to Evaluate Inetetamab + Pyrotinib + Chemotherapy in Previously Untreated HER2-Positive Metastatic Breast Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

December 10, 2022

Primary Completion Date

December 10, 2024

Study Completion Date

December 10, 2025

Conditions
HER2-positive Recurrent/Metastatic Breast Cancer
Interventions
DRUG

Inetetamab, pyrotinib, chemotherapy

"Inetetamab: was administered as an intravenous (IV) loading dose of 8mg/kg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 6mg/kg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination.~pyrotinib: 400 mg once daily orally within 30 minutes after a meal at the same time each day.~chemotherapy:Taxanes (paclitaxel, docetaxel, liposomal paclitaxel, nabpaclitaxel), vinorelbine, capecitabine, eribulin, and other chemotherapeutic agents indicated in advanced breast cancer are permitted. Refer to the appropriate package insert for dosage and administration recommendations."

All Listed Sponsors
lead

Fujian Medical University

OTHER

NCT05621434 - A Study to Evaluate Inetetamab + Pyrotinib + Chemotherapy in Previously Untreated HER2-Positive Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter