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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03863223
Other study ID # HR-BLTN-III-MBC-C
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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