- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03933982
Recruitment Status Recruiting
First Posted May 1, 2019
Last update posted May 29, 2019
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.
|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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
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.
1. Participated in other drug clinical trials within 4 weeks before the start of the
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
Contact: Peng Yuan, M.D. +8613501270834 email@example.com
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
Study Chair: Peng Yuan, M.D. Cancer Institute and Hospital, Chinese Academy of Medical Sciences