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

NCT05841381 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 876

Last updated 2023-05-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-06
Primary Completion
2028-05-06
Completion
2033-05-06

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05841381 on ClinicalTrials.gov