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

• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT02422199
• Collaborator: (none)
• Enrollment: 128
• Locations: 2
• Arms: 2
• Duration (Months): 43
• Patients Per Site: 64
• Patients Per Site Per Month: 1.5

Study Details

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, 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

Study Design

• Study Type: Interventional
• Anticipated 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 1, 2015
• Actual Primary Completion Date: Oct 1, 2016
• Anticipated Study Completion Date: Dec 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Safety(adverse Events [AEs] and Serious Adverse Events [SAEs]) [: From consent through 28 days following treatment completion (estimated 18 months)]

2. Objective Response Rate (ORR) [Estimated 12 months]

Secondary Outcome Measures

1. Progression Free Survival (PFS) [Estimated 18 months]

2. Time to Progression (TTP) [Estimated 18 months]

3. Duration of Response (DOR) [Estimated 18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing	China	100021
2	307 Hospital Affiliated to Academy Military Medical Science	Beijing		China

Sponsors and Collaborators

• Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02422199
• Other Study ID Numbers: HR-BLTN-I/II-MBC
• First Posted: Apr 21, 2015
• Last Update Posted: Jul 9, 2018
• Last Verified: Jul 1, 2018

• Additional relevant MeSH terms: Breast Neoplasms; Capecitabine; Lapatinib

Study Results

No Results Posted as of Jul 9, 2018