A Randomised, Open-label, Parallel Controlled, Multicentre, Phase 3 Clinical Trial of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer:
Sponsor study identifier
interventional
240
1 country
1
Study Start
May 3, 2017
Actual (reported)Primary Completion
March 31, 2019
Actual (reported)Study Completion
March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized,open-label,multi-center,active-controlled, parallel design study of the combination of pyrotinib and capecitabine versus Lapatinib plus capecitabine in HER2+ MBC patients, who have prior received taxane and trastuzumab.Patients will be randomized in a 1:1 ratio to one of the following treatment arms.Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m\^2 twice daily),Arm B: Lapatinib (1250 mg once daily) + capecitabine (1000 mg/m\^2 twice daily).Patients will receive either arm of therapy until disease progression, unacceptable toxicity, or withdrawalof consent.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 3, 2017
Actual (reported)March 15, 2017
Actual (reported)May 3, 2017
Actual (reported)March 31, 2019
Actual (reported)March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Progression Free Survival(PFS)
From infromed consent to progression or death
Estimated 10 months
Safety: AE
AE recorded from infromed consent to 28 days after treatment completion
Overall Survival (OS)
Estimated 30 months
Objective Response Rate (ORR)
Estimated 10 months
Time to Progression (TTP)
Estimated 10 months
Duration of Response (DOR)
Estimated 10 months
pyrotinib(400 mg once daily) + capecitabine (2000 mg/m\^2 daily, 1000 mg/ m\^2 BID)
Lapatinib (1250 mg once daily)+ capecitabine (2000 mg/m\^2 daily, 1000 mg/m\^2 BID)
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Pyrotinib Plus Capecitabine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Lapatinib Plus Capecitabine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordCancer Institute and Hospital,Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
Bao Y, Zhang Z, He X, Cai L, Wang X, Li X. Cost-Effectiveness of Pyrotinib Plus Capecitabine versus Lapatinib Plus Capecitabine for the Treatment of HER2-Positive Metastatic Breast Cancer in China: A Scenario Analysis of Health Insurance Coverage. Curr Oncol. 2022 Aug 23;29(9):6053-6067. doi: 10.3390/curroncol29090476.
Xu B, Yan M, Ma F, Hu X, Feng J, Ouyang Q, Tong Z, Li H, Zhang Q, Sun T, Wang X, Yin Y, Cheng Y, Li W, Gu Y, Chen Q, Liu J, Cheng J, Geng C, Qin S, Wang S, Lu J, Shen K, Liu Q, Wang X, Wang H, Luo T, Yang J, Wu Y, Yu Z, Zhu X, Chen C, Zou J; PHOEBE Investigators. Pyrotinib plus capecitabine versus lapatinib plus capecitabine for the treatment of HER2-positive metastatic breast cancer (PHOEBE): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2021 Mar;22(3):351-360. doi: 10.1016/S1470-2045(20)30702-6. Epub 2021 Feb 11.
First Submitted
March 3, 2017
First Posted
March 15, 2017
Study Start
May 3, 2017
Actual (reported)Primary Completion
March 31, 2019
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Study Completion
March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 18, 2020
Record last verified: 2020-06
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Source: ClinicalTrials.gov.
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