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

Primary Purpose

HER2 Positive Metastatic Breast Cancer

Status

Active

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

pyrotinib

placebo

Capecitabine

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Aged ≥18 and ≤75 years.
ECOG performance status of 0 to 1.
Life expectancy of more than 12 weeks.
According to RECIST 1.1, at least one measurable lesion exists
Histologically or cytologic confirmed HER2 positive advanced breast cancer which failed prior therapies.
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
Previously reveived both Anthracyclin and Taxane.
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.
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.
History of receiving chemotherapy, target-therapy or investigational treatment within 28 days prior to randomization. Received hormone therapy within 7 days prior to randomization.
Brain metastases that are untreated, symptomatic, or require therapy to control symptoms.
Current severe, uncontrolled systemic disease.
Unable or unwilling to swallow tablets.

Sites / Locations

307 Hospital Affiliated to Academy Military Medical Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

arm 1

arm 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

Secondary Outcome Measures

Objective Response Rate (ORR)

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

Duration of Response (DOR)

Clinical Benefit rate (CBR)

Overall Survival (OS)

Full Information

NCT ID

NCT02973737

First Posted

November 22, 2016

Last Updated

October 24, 2022

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02973737

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 20, 2016 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Data Monitoring Committee

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, 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.

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

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 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

279 (Actual)

8. Arms, Groups, and Interventions

Arm Title

arm 1

Arm Type

Experimental

Arm Description

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

Arm Title

arm 2

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

pyrotinib

Intervention Description

400 mg once daily

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

400 mg once daily

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Time Frame

Estimated 10 months

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Time Frame

Estimated 10 months

Title

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

Time Frame

From infromed consent through 28 days following treatment completion

Title

Duration of Response (DOR)

Time Frame

Estimated 10 months

Title

Clinical Benefit rate (CBR)

Time Frame

Estimated 10 months

Title

Overall Survival (OS)

Time Frame

Estimated 30 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged ≥18 and ≤75 years. ECOG performance status of 0 to 1. Life expectancy of more than 12 weeks. According to RECIST 1.1, at least one measurable lesion exists Histologically or cytologic confirmed HER2 positive advanced breast cancer which failed prior therapies. 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 Previously reveived both Anthracyclin and Taxane. 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. 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. History of receiving chemotherapy, target-therapy or investigational treatment within 28 days prior to randomization. Received hormone therapy within 7 days prior to randomization. Brain metastases that are untreated, symptomatic, or require therapy to control symptoms. Current severe, uncontrolled systemic disease. Unable or unwilling to swallow tablets.

Facility Information:

Facility Name

307 Hospital Affiliated to Academy Military Medical Science

City

Beijing

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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