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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

590 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-22

Study Completion Date

2024-07-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Metastatic Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Pyrotinib Plus trastuzumab and docetaxel

Group Type EXPERIMENTAL

Pyrotinib, Trastuzumab, Docetaxel

Intervention Type DRUG

Pyrotinib 400mg orally daily until progressive disease

B

Placebo plus trastuzumab and docetaxel

Group Type PLACEBO_COMPARATOR

Placebo, Trastuzumab, Docetaxel

Intervention Type DRUG

Placebo 400mg orally daily until progressive disease

Interventions

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Pyrotinib, Trastuzumab, Docetaxel

Pyrotinib 400mg orally daily until progressive disease

Intervention Type DRUG

Placebo, Trastuzumab, Docetaxel

Placebo 400mg orally daily until progressive disease

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No