Breast cancer
Conditions
Interventions
Case series:Pyrrotinib + trastuzumab + vinorelbine
Sponsors
Cancer hospital of Chinese academy of medical sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Female patients >=18 years old; 2. ECOG score 0-1; 3. The expected survival time is not less than 12 weeks; 4. Pathology confirmed HER2 positive breast cancer.The criteria for HER2 positivity follow the 2018 ASCO-CAP guidelines for HER2 positivity. The immunohistochemical (IHC) score of 3+ or 2+ was confirmed by the pathology laboratory and the test was positive by in situ hybridization (ISH). 5. Received <=4 systemic treatment schemes in the stage of metastasis; 6. There is at least one measurable target lesion required by RECIST 1.1; 7. Voluntary participation in the study, signed informed consent, good compliance and willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Known history of allergy to any component of the drug; 2. Patients with uncontrolled brain metastasis; 3. There are various factors affecting the absorption of oral drugs, such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction; 4. Female patients during pregnancy and lactation, female patients with fertility who tested positive in the baseline pregnancy test or female patients of child-bearing age who were not willing to take effective contraceptive measures during the whole trial period; 5. According to the judgment of the researcher, there are serious concomitant diseases (including but not limited to severe hypertension and severe diabetes that cannot be controlled by drugs) that seriously endanger the safety of patients or affect the completion of the study; 6. The investigator considers that the patient is not suitable for any other circumstances in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;DCR;DCR; | — |
Countries
China
Contacts
Public ContactCai Ruigang
Jiangsu hengrui pharmaceutical co. LTD
Outcome results
None listed