Breast cancer
Conditions
Interventions
Test group:HS022+Vinorelbine
Control group:Trastuzumab +vinorelbine for injection
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female =18 and =75 years of age on day of signing the informed consent form (ICF). 2. Histologically confirmed adenocarcinoma of the breast. 3. Recurrent disease not amenable to curative surgery or radiation therapy. 4. HER2-positivity, based on IHC score 3+ or ISH positivity. For those IHC score 2+ patients, fluorescence in situ hybridization (FISH), chromogenic in situ hybridization (CISH) or silver enhanced in situ hybridization (SISH) should be tested to prove HER2 gene amplification. 5. No prior systemic anticancer agent such as chemotherapy, biological or targeted agent for metastatic disease. For patients with recurrent disease, prior neo-/adjuvant therapy containing trastuzumab must have been stopped at least 12 months before the diagnosis of recurrent (local or metastatic) disease. 6. Those with at least one measurable target lesion (RECIST 1.1 standard): at least one diameter line of the target lesion can be accurately measured, and the lesions were irradiated or had any forms of local intervention, skin lesions, brain lesions, and bone lesions can only be evaluated as non-target lesions; 7. ECOG <2; 8. Left ventricular ejection fraction (LVEF) = 50% within 4 weeks before randomization; 9. Adequate hematology, liver function and kidney function, as shown in the following laboratory test values a) Absolute value of neutrophil = 1.5 × 109/L b) Platelet = 100 × 109/L, and hemoglobin = 90g/L; c) Total serum bilirubin = 1.5 times the upper limit of normal value (except for Gilbert syndrome); d) ALT and AST = 2.5 times the upper limit of normal value (subjects with liver metastasis = 5 times the upper limit of normal value); e) Blood creatinine = 1.5 times the upper limit of normal value. 10.The expected survival period = 3 months. 11. Patients have voluntarily agreed to participate and given written informed consent.
Exclusion criteria
Exclusion criteria: 1.Prior surgery within 4 weeks preceeding enrollment or expected to be performed during the trial, prior chemotherapy wihtin 4 weeks preceeding enrollment, prior radiotherapy or endocrinotherapy within 4 weeks before enrollment. 2.Prior treatment with vinorelbine; 3.Current peripheral neuropathy above 2 grades; 4.Known brain metastasis or other CNS metastasis that is either symptomatic or untreated. Central nervous system metastases that have been treated by complete resection and/or radiotherapy demonstrating stability or improvement are not an exclusion criterion provided they are stable as shown by computed tomography (CT) or magnetic resonance imaging (MRI) scan for at least 4 weeks before Screening without evidence of cerebral edema and no requirements for corticosteroids or anticonvulsants. 5.Participation in another clinical study within 4 weeks before enrollment (3 months for studies involving monoclonal therapy), excluding those who failed in screening; 6. Patients with any other malignant tumor in the past five years, excluding fully cured cervical carcinoma in situ, basal cell or squamous cell skin cancer; 7. A clear history of neurological or mental disorders, including epilepsy or dementia; 8. Those who are allergic to any ingredient or excipient of the test drug, including those who are allergic to benzyl alcohol; 9. Those who have received whole blood or component blood transfusion within 2 weeks before randomization; 10. Those who currently suffer from diseases affecting intravenous injection and venous blood collection; 11. Presence of serious and uncontrollable systemic diseases (such as dyspnea, bronchospasm, acute attack of asthma or other diseases requiring continuous oxygen inhalation treatment), which, according to the judgment of the researcher, will significantly affect the participation/completion of the trial and efficacy evaluation; 12. Any of the following heart diseases: a) Currently untreated or uncontrollable hypertension (systolic blood pressure>150 mmHg or diastolic blood pressure>100 mmHg), or unstable angina pectoris; b) A history of congestive heart failure at any level according to the New York Heart Association criteria, or serious arrhythmia requiring treatment (excluding atrial fibrillation or paroxysmal supraventricular tachycardia); c) Myocardial infarction occurred within 6 months before signing the informed consent; 13. A current long-term use of corticosteroids everyday (>10 mg/day methylprednisolone as an equivalent dose), excluding inhaled corticosteroids; 14. A positive presence in terms of antibody to human immunodeficiency virus, treponema pallidum and hepatitis C virus, or active hepatitis B infection with clinical significance needing treatment: positive testing for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb], with hepatitis B virus deoxyribonucleic acid [HBV DNA] = the upper limit of reference. Among them, positive syphilis specific antibody with negative syphilis non-specific antibody can be enrolled; positive hepatitis C virus antibody with negative hepatitis C virus RNA [HCV RNA] can be enrolled; 15. Pregnant or lactating women; Or women of childbearing age with positive blood pregnancy tests; Or women of childbearing age and their spouses are unwilling to take effective contraceptive measures during and within 7 months after the end of the clinical trial; 16. Other factors that are not suitable for enrollmen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The best overall response rate (ORR24); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR);The duration of remission (DoR);Progression-free survival rate (PFS:);Overall survival rate (OS rate);Vital signs;physical examination;ECOG physical condition;left ventricular ejection fraction (LVEF);laboratory examination;adverse events (AE);The incidence of anti-drug antibodies (ADAs) ;Valley concentration Ctrough; | — |
Countries
China
Contacts
Public ContactTang Jinhai/Jiang Zefei
Jiangsu Province People's Hospital (First Affiliated Hospital of Nanjing Medical University)
Outcome results
None listed