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

NCT02973737 | Unknown Phase 3

• 1 other identifier: HR-BLTN-Ⅲ-MBC-A
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 1

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.

Conditions

HER2 Positive Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Estimated 10 months

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  Estimated 10 months

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

  From infromed consent through 28 days following treatment completion

• Duration of Response (DOR)

  Estimated 10 months

• Clinical Benefit rate (CBR)

  Estimated 10 months

• Overall Survival (OS)

  Estimated 30 months

Study Arms (2)

arm 1

EXPERIMENTAL

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

Drug: pyrotinib; Drug: Capecitabine

arm 2

ACTIVE COMPARATOR

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

Drug: placebo; Drug: Capecitabine

Interventions

pyrotinib DRUG

400 mg once daily

arm 1

placebo DRUG

400 mg once daily

arm 2

Capecitabine DRUG

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

arm 1; arm 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

307 Hospital Affiliated to Academy Military Medical Science

Beijing, China

Location

MeSH Terms

Interventions

pyrotinib; Capecitabine

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 25, 2016
• Study Start: July 20, 2016
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)