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This is a prospective, no interventional, single arm cohort study, which aims to study the efficacy and safety of inetetamab combined with pyrotinib and vinorelbine in the Treatment of HER2 positive advanced breast cancer in the real world. The study will be conducted by signing an informed consent form for study enrollment, collecting patient case information, and conducting observation and follow-up.
This is a prospective, no interventional, single arm cohort study, which aims to study the efficacy and safety of inetetamab combined with pyrotinib and vinorelbine in the Treatment of HER2 positive advanced breast cancer in the real world. The study will be conducted by signing an informed consent form for study enrollment, collecting patient case information, and conducting observation and follow-up.The research process is divided into screening period, treatment period, and survival and follow-up periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group of ues of inetetamab combined with pyrotinib and vinorelbine | Group of ues of inetetamab combined with pyrotinib and vinorelbine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inetetamab Combined With Pyrotinib and Vinorelbine | Drug | Inetetamab Combined With Pyrotinib and Vinorelbine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progressive free survival(PFS) | The time between the date of treatment of inetetamab combined with pyrotinib and vinorelbine and the progression of the tumor or death from any cause. | From date of treatment of inetetamab combined with pyrotinib and vinorelbine until the date of the progression of the tumor or death from any cause, whichever came first, assessed up to about 48 months |
| Adverse events | The duration of adverse reaction data collection should be from the date the patient started medication to 30 days after the end of the last medication | assessed up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival(OS) | Refers to the time between the date when the patient starts treatment of inetetamab combined with pyrotinib and vinorelbine and vinorelbine and death from any cause. | From date of the patient starts treatment of inetetamab combined with pyrotinib and vinorelbine and vinorelbine and death from any cause,assessed up to about 48 months. |
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Inclusion Criteria:
(1) HER2 positive is defined as>10% of immunoreactive cells with an immunohistochemical (IHC) score of 3 or an in situ hybridization (ISH) result of HER2 gene amplification (2) Advanced breast cancer is defined as locally advanced breast cancer or metastatic breast cancer that cannot be removed by radical surgery confirmed by researchers; 3. The functional level of the main organs has been evaluated by the researchers to withstand chemotherapy, anti HER2 monoclonal antibodies, and anti HER2 TKI drugs. The LVEF and QT intervals measured by echocardiography or MUGA are within a clinically acceptable safety range. If the survival benefits of the treatment value are assessed by the researcher to be greater than the risks faced, the admission conditions for the specific organ function level can be appropriately relaxed by the researcher, but the reasons need to be explained in the medical record; 4. ECOG score: 0-2 points; 5. Voluntarily sign the informed consent form for this study. 6. Contraception during the study period and within 6 months after treatment, non lactation.
Exclusion Criteria:
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patients with HER2 positive dvanced breast cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen zhanhong | Contact | +8613606505124 | czred@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Chen zhanhong | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31430226 | Result | Ma F, Ouyang Q, Li W, Jiang Z, Tong Z, Liu Y, Li H, Yu S, Feng J, Wang S, Hu X, Zou J, Zhu X, Xu B. Pyrotinib or Lapatinib Combined With Capecitabine in HER2-Positive Metastatic Breast Cancer With Prior Taxanes, Anthracyclines, and/or Trastuzumab: A Randomized, Phase II Study. J Clin Oncol. 2019 Oct 10;37(29):2610-2619. doi: 10.1200/JCO.19.00108. Epub 2019 Aug 20. | |
| 33581774 |
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| ID | Term |
|---|---|
| C000622954 | pyrotinib |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
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| Objective response rate(ORR) | Refers to the proportion of patients whose tumors have shrunk to a certain amount and remained for a certain period of time. The percentage of cases that include CR and PR in the number of evaluable cases. | up to 48 months. |
| Disease Control Rate (DCR) | Refers to the percentage of confirmed cases of complete remission (CR), partial remission (PR), and disease stabilization (SD) (≥ 4 weeks) among patients with evaluable efficacy. | up to 48 months. |
| Xu B, Yan M, Ma F, Hu X, Feng J, Ouyang Q, Tong Z, Li H, Zhang Q, Sun T, Wang X, Yin Y, Cheng Y, Li W, Gu Y, Chen Q, Liu J, Cheng J, Geng C, Qin S, Wang S, Lu J, Shen K, Liu Q, Wang X, Wang H, Luo T, Yang J, Wu Y, Yu Z, Zhu X, Chen C, Zou J; PHOEBE Investigators. Pyrotinib plus capecitabine versus lapatinib plus capecitabine for the treatment of HER2-positive metastatic breast cancer (PHOEBE): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2021 Mar;22(3):351-360. doi: 10.1016/S1470-2045(20)30702-6. Epub 2021 Feb 11. |
| D006571 |
| Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |