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A Study of Pyrotinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02973737
Recruitment Status : Unknown
Verified December 2017 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : November 25, 2016
Last Update Posted : December 20, 2017
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, double blind, active-controlled, parallel design study of the combination of pyrotinib in combination with capecitabine versus placebo plus capecitabine in HER2+ MBC patients, who have prior received anthracyclin, taxane and trastuzumab.

Patients will be randomized in a 2:1 ratio to one of the following treatment arms:

Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m^2 twice daily) Arm B: placebo (400 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.

Patients in control group can be provide pyrotinib treatment when they progressed after the placebo plus capecitabine treatment.


Condition or disease Intervention/treatment Phase
HER2 Positive Metastatic Breast Cancer Drug: pyrotinib Drug: placebo Drug: Capecitabine Phase 3

Detailed Description:

This study is a phase 3, randomized, multi-center, multinational, double blind, active-controlled, parallel design study of the combination of pyrotinib in combination with capecitabine versus placebo plus capecitabine in HER2+ MBC patients, who have prior received anthracyclin, taxane and trastuzumab.

Patients will be randomized in a 2:1 ratio to one of the following treatment arms:

Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m^2 twice daily) Arm B: placebo (400 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.

Efficacy assessments will be performed at screening, every 6 weeks until cycle 18, every 12 weeks thereafter.

Patients in control group can be provide pyrotinib treatment when they progressed after the placebo plus capecitabine treatment. Pyrotinb will be administrated until the patients reached progress again or wit

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pyrotinib Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer:a Randomised, Double-blind, Multicentre, Phase 3 Trial
Study Start Date : July 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: arm 1
pyrotinib plus capecitabine pyrotinib(400 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID)
Drug: pyrotinib
400 mg once daily

Drug: Capecitabine
1000 mg/m2 per day on day 1 through 14, every 21 days.

Active Comparator: arm 2
placebo plus capecitabine placebo(400 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID)
Drug: placebo
400 mg once daily

Drug: Capecitabine
1000 mg/m2 per day on day 1 through 14, every 21 days.




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Estimated 10 months ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Estimated 10 months ]
  2. Safety(adverse Events [AEs] and Serious Adverse Events [SAEs]) [ Time Frame: From infromed consent through 28 days following treatment completion ]
  3. Duration of Response (DOR) [ Time Frame: Estimated 10 months ]
  4. Clinical Benefit rate (CBR) [ Time Frame: Estimated 10 months ]
  5. Overall Survival (OS) [ Time Frame: Estimated 30 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:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged ≥18 and ≤75 years.
  2. ECOG performance status of 0 to 1.
  3. Life expectancy of more than 12 weeks.
  4. According to RECIST 1.1, at least one measurable lesion exists
  5. Histologically or cytologic confirmed HER2 positive advanced breast cancer which failed prior therapies.
  6. Prior treatment with trastuzumab(≥2 cycles in the metastatic setting, or ≥3 months in adjuvant setting), and the patients are not available for the trastuzumab or lapatinib
  7. Previously reveived both Anthracyclin and Taxane.
  8. Required laboratory values including following parameters:

    ANC: ≥ 1.5 x 10^9/L; Platelet count: ≥ 90 x 10^9/L; Hemoglobin: ≥ 9.0 g/dL; Total bilirubin: ≤ 1.5 x upper limit of normal (ULN); ALT and AST: ≤ 2 x ULN(patients with liver metastases: </= 5 x ULN); BUN and Creatinine: ≤ 1.5 x ULN;LVEF: ≥ 50%;QTcF: < 470 ms.

  9. Signed informed consent

Exclusion Criteria:

  1. Received previous therapy with lapatinib, neratinib, pyrotinib or any other HER2 directe tyrosine kinase inhibitor.
  2. Received previous therapy with capecitabine.
  3. History of receiving chemotherapy, target-therapy or investigational treatment within 28 days prior to randomization. Received hormone therapy within 7 days prior to randomization.
  4. Brain metastases that are untreated, symptomatic, or require therapy to control symptoms.
  5. Current severe, uncontrolled systemic disease.
  6. Unable or unwilling to swallow tablets.

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): NCT02973737


Locations
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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: NCT02973737    
Other Study ID Numbers: HR-BLTN-Ⅲ-MBC-A
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents