A Study of Pyrotinib in Combination With Trastuzumab and Docetaxel in Patients With HER2 Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

A Phase 3,Randomized, Double-blinded, Placebo-controlled Study to Evaluate Efficacy and Safety of Pyrotinib Plus Trastuzumab and Docetaxel Versus Placebo Plus Trastuzumab and Docetaxel in Patients With HER2 Positive MBC.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03863223
• Other study ID #: HR-BLTN-III-MBC-C
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 22, 2019
• Est. completion date: July 30, 2024

Study information

• Verified date: November 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blinded, multicenter phase 3 clinical trial to evaluate the efficacy and safety of pyrotinib plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus docetaxel in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 590
• Est. completion date: July 30, 2024
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. HER2 positive recurrent or metastasis breast cancer.

2. Patients with measurable disease are eligible.

3. Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.

4. Adequate organ function.

5. Signed, written inform consent obtained prior to any study procedure.

Exclusion Criteria:

1. History of anti-cancer therapy for MBC(with the exception of one prior hormonal regimen for MBC).

2. History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting,except trastuzumab used in the neo-adjuvant or adjuvant setting.

3. Assessed by the investigator to be unable receive systemic chemotherapy.

4. History of other malignancy within the last 5 years,except for carcinoma in situ of cervix,basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent.

5. Pregnant or lactating women,or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Pyrotinib, Trastuzumab, Docetaxel
Pyrotinib 400mg orally daily until progressive disease
• Placebo, Trastuzumab, Docetaxel
Placebo 400mg orally daily until progressive disease

Locations

Country	Name	City	State
China	Cancer Institute and Hospital,Chinese Academy of Medical Science	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Progression Free Survival	Approximately 42 months
Secondary	AEs+SAEs	Adverse Events and Serious Adverse Events	From the first drug administration to within 28 days for the last treatment
Secondary	OS	Overall Survival	Up to 2 years
Secondary	ORR	Objective Response Rate	Approximately 42 months
Secondary	DoR	Duration of Objective Response	Approximately 42 months
Secondary	CBR	Clinical Benefit rate	From the start of randomization to 6 months