A Study of Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer (Pyrotinib)
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|ClinicalTrials.gov Identifier: NCT03933982|
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : May 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Brain Metastases||Drug: Pyrotinib Plus Vinorelbine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer : a Prospective, Single-arm, Open-label Study|
|Actual Study Start Date :||December 22, 2018|
|Estimated Primary Completion Date :||December 22, 2021|
|Estimated Study Completion Date :||June 22, 2022|
|Experimental: Pyrotinib plus Vinorelbine||
Drug: Pyrotinib Plus Vinorelbine
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.
- Objective Response Rate (ORR) of CNS [ Time Frame: Estimated up to 1 year ]ORR, defined as proportion of complete response and partial response according to RANO-Brain Metastases (RANO-BM) criteria.
- Time to progression (TTP) [ Time Frame: Estimated up to 1 year ]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 (overall survival) [ Time Frame: Estimated up to 1 year ]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 [ Time Frame: Estimated up to 1 year ]Time to radiotherapy, defined as the time from the date of informed consent until to the date of radiotherapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933982
|Contact: Peng Yuan, M.D.||+firstname.lastname@example.org|
|Study Chair:||Peng Yuan, M.D.||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|