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A Study of Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer

Study Purpose

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER1, HER2 and HER4 receptors. This study is a single-arm, prospective, open label clinical study of pyrotinib plus vinorelbine as the therapy of brain metastases from HER2-positive metastatic breast cancer.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 75 Years
Gender Female
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age18-75 years. 2. ECOG performance status ≤2. 3. Histologically confirmed HER2 positive advanced breast cancer. 4. Prior to anthracyclines and taxanes (neoadjuvant, adjuvant and metastatic setting). Received ≤4 regimes in metastatic setting. Prior to trastuzumab is allowed. 5. Not received whole brain radiotherapy (WBRT) or recurrence after WBRT. 6. Controlled CNS symptoms (headache, dizziness, lethargy, nausea etc.). 7. Patients with CNS metastasis; at least one CNS metastases with a longest diameter ≥1 cm and a diameter perpendicular to the longest diameter should be ≥0.5 cm; 8. Signed the informed consent form prior to patient entry.

Exclusion Criteria:

1. Participated in other drug clinical trials within 4 weeks before the start of the study; 2. Received radiotherapy, chemotherapy, surgery and target therapy within 4 weeks before the start of the study; 3. Received endocrine therapy within 7 days before the start of the study; 4. Suitable for surgical resection; 5. Accompanied by rapid progress of organ invasion; 6. Factors influencing the usage of oral administration (such as unable to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction etc.). 7. Prior to pyrotinib or vinorelbine or anti-HER2 TKI drugs; 8. Allergies to any compounds of experimental drugs; 9. CNS disorders or mental disorders, history of clear neurological or mental disorders, including epilepsy or dementia; 10. Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma. 11. Any other situations judged by investigator as not suitable for participating in this study.

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Chinese Academy of Medical Sciences
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Peng Yuan, M.D.
Principal Investigator Affiliation Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries China

The disease, disorder, syndrome, illness, or injury that is being studied.

Breast Cancer, Brain Metastases
Arms & Interventions


Experimental: Pyrotinib plus Vinorelbine


Drug: - Pyrotinib Plus Vinorelbine

Pyrotinib: 320mg/d, q.d., p.o. A course of treatment need 21 days. Vinorelbine: 60mg/m2 q.d. d1,8,15, p.o. A course of treatment need 21 day.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing, China




Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, ,

Site Contact

Peng Yuan, M.D.