Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT05841381
PHASE3

Adjuvant Study of Pyrotinib in Combination With Trastuzumab in HER2 Positive Invasive Breast Cancer

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

This is an open label, phase III study evaluating the efficacy and safety of Pyrotinib in Combination With Trastuzumab and paclitaxel in patients HER2 Positive and lymph node negative invasive Breast Cancer

Official title: Adjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive and Lymph Node Negative Invasive Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

876

Start Date

2023-05-06

Completion Date

2033-05-06

Last Updated

2023-05-03

Healthy Volunteers

No

Conditions

Interventions

DRUG

Pyrotinib

pyrotinib: 400mg orally daily for 1 year

DRUG

Trastuzumab

8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 17 cycles

DRUG

Paclitaxel

80mg/m2 per week for a total of 12 weeks