Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Vinorelbine

Tubulin Modulators

Antimitotic Agents

pyrotinib 320mg tablets administered daily by mouth, vinorelbine(po) 80 mg/m2 weekly (following a first cycle at 60 mg/m2) administered on day 1 and day 8 of 21 day cycle. Treatment lasts for two cycles

Pyrotinib 320mg + Vinorelbine

pyrotinib 400mg tablets administered daily by mouth, vinorelbine(po) 80 mg/m2 weekly (following a first cycle at 60 mg/m2) administered on day 1 and day 8 of 21 day cycle. Treatment lasts for two cycles

Pyrotinib 400mg + Vinorelbine

pyrotinib administered daily by mouth（MTD）, vinorelbine(po) 80 mg/m2 weekly (following a first cycle at 60 mg/m2) administered on day 1 and day 8 of 21 day cycle, or vinorelbine(iv) 25 mg/m2 on day 1 and day 8 of 21 day cycle. Treatments will lasts until disease progression (as assessed by the investigator) or unmanageable toxicity.

Pyrotinib plus Vinorelbine

wang shusen

zhang jingmin

The purpose of this study is to identify the highest tolerable dose of pyrotinib in combination with vinorelbine and to assess the safety and efficacy of the combination in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer.

The study will be conducted in two parts. In the first part, testing will be done on up to 12 subjects to determine the highest tolerable dose of pyrotinib and vinorelbine in patients with advanced solid tumors. In the second part of the study, we will explore the safety and efficacy of Pyrotinib + vinorelbine in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination.

Pyrotinib Plus Vinorelbine in Participants With HER2-positive Previously Treated Locally Advanced or Metastatic Breast Cancer

A Single-arm, Multi-center Phase II Clinical Study of Pyrotinib Combined With Vinorelbine in the Treatment of HER2-positive and Treated Metastatic Breast Cancer

from enrollment to progression or death (for any reason), assessed up to 3 years

OS was defined as the time from the date of randomization to the date of death from any cause.

Sun Yat-sen University

Symptoms and General Pathology

Nervous System Diseases

Neoplasm Metastasis

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Pyrotinib: 320mg/d, q.d., p.o. A course of treatment need 21 days. Vinorelbine: 60mg/m2 q.d. d1,8,15, p.o. A course of treatment need 21 day.

Pyrotinib Plus Vinorelbine

Peng Yuan, M.D.

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER1, HER2 and HER4 receptors. This study is a single-arm, prospective, open label clinical study of pyrotinib plus vinorelbine as the therapy of brain metastases from HER2-positive metastatic breast cancer.

A Study of Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer

Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer : a Prospective, Single-arm, Open-label Study

ORR, defined as proportion of complete response and partial response according to RANO-Brain Metastases (RANO-BM) criteria.

TTP, defined as the time from the date of informed consent until the date of disease progression (PD), either CNS PD or extracranial PD, whichever comes first.

OS, defined as the time from the date of informed consent until to the date of death, regardless of the cause of death.

Time to radiotherapy, defined as the time from the date of informed consent until to the date of radiotherapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pyrotinib Plus Vinorelbine in Participants With HER2-positive Previously Treated Locally Advanced or Metastatic Breast Cancer	NCT04605575	Breast Cancer Pyrotinib Breast Diseases Vinorelbine HER2-positive B...	Pyrotinib 320mg... Pyrotinib 400mg... Pyrotinib plus ...	18 Years - 70 Years	Sun Yat-sen University
A Study of Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer	NCT03933982	Breast Cancer Brain Metastase...	Pyrotinib Plus ...	18 Years - 75 Years	ChineseAMS
Pyrotinib Plus Vinorelbine in Participants With HER2-positive Previously Treated Locally Advanced or Metastatic Breast Cancer	NCT04605575	Breast Cancer Pyrotinib Breast Diseases Vinorelbine HER2-positive B...	Pyrotinib 320mg... Pyrotinib 400mg... Pyrotinib plus ...	18 Years - 70 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for pyrotinib plus vinorelbine