NCT02422199

Brief Summary

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of pyrotinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have prior received anthracyclin, taxane or trastuzumab. Patients will be stratified by weather have prior use of trastuzumab and 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 the occurrence of death, disease progression, unacceptable toxicity, or other specified withdrawal criterion.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2015

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 9, 2018

Status Verified

July 1, 2018

Enrollment Period

1.4 years

First QC Date

April 16, 2015

Last Update Submit

July 5, 2018

Conditions

HER2 Positive Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Safety(adverse Events [AEs] and Serious Adverse Events [SAEs])

    : From consent through 28 days following treatment completion (estimated 18 months)

  • Objective Response Rate (ORR)

    Estimated 12 months

Secondary Outcomes (3)

  • Progression Free Survival (PFS)

    Estimated 18 months

  • Time to Progression (TTP)

    Estimated 18 months

  • Duration of Response (DOR)

    Estimated 18 months

Study Arms (2)

pyrotinib plus capecitabine

EXPERIMENTAL

pyrotinib(400 mg once daily) + capecitabine (2000 mg/m\^2 daily, 1000 mg/m\^2 BID)

Drug: pyrotinibDrug: capecitabine

lapatinib plus capecitabine

ACTIVE COMPARATOR

lapatinib (1250 mg once daily) + capecitabine (2000 mg/m\^2 daily, 1000 mg/m\^2 BID)

Drug: LapatinibDrug: capecitabine

Interventions

pyrotinibDRUG
pyrotinib plus capecitabine
LapatinibDRUG
lapatinib plus capecitabine
capecitabineDRUG
lapatinib plus capecitabinepyrotinib plus capecitabine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged ≥18 and ≤70 years.
  • ECOG performance status of 0 to 1.
  • Life expectancy of more than 12 weeks.
  • At least one measurable lesion exists.(RECIST 1.1).
  • Histologically or cytologic confirmed HER2 positive advanced breast cancer which failed prior therapies.
  • Required laboratory values including following parameters:
  • ANC: ≥ 1.5 x 10\^9/L;Platelet count: ≥ 100 x 10\^9/L;Hemoglobin: ≥ 9.0 g/dL;Total bilirubin: ≤ 1.5 x upper limit of normal (ULN);ALT and AST: ≤ 1.5 x ULN;BUN and creatine clearance rate: ≥ 50 mL/min;LVEF: ≥ 50%;QTcF: \< 470 ms for female and \< 450 ms for male.
  • Signed informed consent

You may not qualify if:

  • Received previous therapy with lapatinib, neratinib, pyrotinib or any other HER2 directe tyrosine kinase inhibitor.
  • Received previous therapy with capecitabine within 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

307 Hospital Affiliated to Academy Military Medical Science

Beijing, China

Location

Related Publications (1)

  • 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.

    PMID: 36135045DERIVED

MeSH Terms

Interventions

pyrotinibLapatinibCapecitabine

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2015

First Posted

April 21, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 1, 2018

Last Updated

July 9, 2018

Record last verified: 2018-07

Locations

CN(2)