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

NCT ID: NCT02973737

Last Updated: 2022-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 279 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-20
• Study Completion Date: 2023-06-30

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

Conditions

HER2 Positive Metastatic Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

arm 1

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

Group Type: EXPERIMENTAL

pyrotinib

Intervention Type: DRUG

400 mg once daily

Capecitabine

Intervention Type: DRUG

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

arm 2

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

Group Type: ACTIVE_COMPARATOR

placebo

Intervention Type: DRUG

400 mg once daily

Capecitabine

Intervention Type: DRUG

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

Interventions

pyrotinib

400 mg once daily

Intervention Type: DRUG

placebo

400 mg once daily

Intervention Type: DRUG

Capecitabine

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

307 Hospital Affiliated to Academy Military Medical Science

Beijing, , China

Countries

China

Other Identifiers

HR-BLTN-Ⅲ-MBC-A

Identifier Type: -

Identifier Source: org_study_id