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A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab

Primary Purpose

HER2 Positive Metastatic Breast Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
pyrotinib
Lapatinib
capecitabine
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HER2 Positive Metastatic Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • 307 Hospital Affiliated to Academy Military Medical Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

pyrotinib plus capecitabine

lapatinib plus capecitabine

Arm Description

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)

Outcomes

Primary Outcome Measures

Safety(adverse Events [AEs] and Serious Adverse Events [SAEs])
Objective Response Rate (ORR)

Secondary Outcome Measures

Progression Free Survival (PFS)
Time to Progression (TTP)
Duration of Response (DOR)

Full Information

First Posted
April 16, 2015
Last Updated
July 5, 2018
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02422199
Brief Title
A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab
Official Title
A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2 Positive Metastatic Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pyrotinib plus capecitabine
Arm Type
Experimental
Arm Description
pyrotinib(400 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID)
Arm Title
lapatinib plus capecitabine
Arm Type
Active Comparator
Arm Description
lapatinib (1250 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID)
Intervention Type
Drug
Intervention Name(s)
pyrotinib
Intervention Type
Drug
Intervention Name(s)
Lapatinib
Intervention Type
Drug
Intervention Name(s)
capecitabine
Primary Outcome Measure Information:
Title
Safety(adverse Events [AEs] and Serious Adverse Events [SAEs])
Time Frame
: From consent through 28 days following treatment completion (estimated 18 months)
Title
Objective Response Rate (ORR)
Time Frame
Estimated 12 months
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Time Frame
Estimated 18 months
Title
Time to Progression (TTP)
Time Frame
Estimated 18 months
Title
Duration of Response (DOR)
Time Frame
Estimated 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Received previous therapy with lapatinib, neratinib, pyrotinib or any other HER2 directe tyrosine kinase inhibitor. Received previous therapy with capecitabine within 3 months.
Facility Information:
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
307 Hospital Affiliated to Academy Military Medical Science
City
Beijing
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
36135045
Citation
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.
Results Reference
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A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab

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