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Trial record 96 of 125 for:    lapatinib | Recruiting, Active, not recruiting, Completed Studies | Phase 2

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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ClinicalTrials.gov Identifier: NCT02422199
Recruitment Status : Active, not recruiting
First Posted : April 21, 2015
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
HER2 Positive Metastatic Breast Cancer Drug: pyrotinib Drug: Lapatinib Drug: capecitabine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2015
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: pyrotinib plus capecitabine
pyrotinib(400 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID)
Drug: pyrotinib
Drug: capecitabine
Active Comparator: lapatinib plus capecitabine
lapatinib (1250 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID)
Drug: Lapatinib
Drug: capecitabine



Primary Outcome Measures :
  1. Safety(adverse Events [AEs] and Serious Adverse Events [SAEs]) [ Time Frame: : From consent through 28 days following treatment completion (estimated 18 months) ]
  2. Objective Response Rate (ORR) [ Time Frame: Estimated 12 months ]

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Estimated 18 months ]
  2. Time to Progression (TTP) [ Time Frame: Estimated 18 months ]
  3. Duration of Response (DOR) [ Time Frame: Estimated 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT02422199


Locations
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China, Beijing
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100021
China
307 Hospital Affiliated to Academy Military Medical Science
Beijing, China
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02422199     History of Changes
Other Study ID Numbers: HR-BLTN-I/II-MBC
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Lapatinib
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Trastuzumab
Taxane
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological
Protein Kinase Inhibitors
Enzyme Inhibitors