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

  • STATUS
    Recruiting
  • End date
    Jul 30, 2024
  • participants needed
    590
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
Updated on 25 January 2021
measurable disease
breast cancer
metastasis
HER2
trastuzumab
cancer treatment

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.

Details
Condition Metastatic Breast Cancer, Stage IV Breast Cancer
Treatment Pyrotinib, Trastuzumab, Docetaxel, Placebo, Trastuzumab, Docetaxel
Clinical Study IdentifierNCT03863223
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Are you female?
Do you have Metastatic Breast Cancer?
Do you have any of these conditions: Metastatic Breast Cancer or Stage IV Breast Cancer?
HER2 positive recurrent or metastasis breast cancer
Patients with measurable disease are eligible
Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1
Adequate organ function
Signed, written inform consent obtained prior to any study procedure

Exclusion Criteria

History of anti-cancer therapy for MBCwith the exception of one prior hormonal regimen for MBC
History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment settingexcept trastuzumab used in the neo-adjuvant or adjuvant setting
Assessed by the investigator to be unable receive systemic chemotherapy
History of other malignancy within the last 5 yearsexcept for carcinoma in situ of cervixbasal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent
Pregnant or lactating womenor 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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