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

• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT02973737
• Collaborator: (none)
• Enrollment: 350
• Location: 1
• Arms: 2
• Duration (Months): 41
• Patients Per Site Per Month: 8.5

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, 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

Study Design

• Study Type: Interventional
• Anticipated 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: Jul 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2018
• Anticipated Study Completion Date: Dec 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival (PFS) [Estimated 10 months]

Secondary Outcome Measures

1. Objective Response Rate (ORR) [Estimated 10 months]

2. Safety(adverse Events [AEs] and Serious Adverse Events [SAEs]) [From infromed consent through 28 days following treatment completion]

3. Duration of Response (DOR) [Estimated 10 months]

4. Clinical Benefit rate (CBR) [Estimated 10 months]

5. Overall Survival (OS) [Estimated 30 months]

Eligibility Criteria

Criteria

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

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.

1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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: NCT02973737
• Other Study ID Numbers: HR-BLTN-Ⅲ-MBC-A
• First Posted: Nov 25, 2016
• Last Update Posted: Dec 20, 2017
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Breast Neoplasms; Capecitabine

Study Results

No Results Posted as of Dec 20, 2017