Combining inetetamab, pyrotinib, and vinorelbine for treating advanced HER2-positive breast cancer
Efficacy and Safety of Inetetamab Combined With Pyrotinib and Vinorelbine in the Treatment of Advanced Breast Cancer
This study is testing a new combination of three drugs to see if they can help people with advanced HER2-positive breast cancer feel better and live longer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy, inetetamab, pyrotinib |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05856383 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the efficacy and safety of a combination treatment involving inetetamab, pyrotinib, and vinorelbine for patients with HER2-positive advanced breast cancer. The study will enroll participants who provide informed consent and will collect detailed patient case information throughout the treatment process. It includes a screening period, treatment period, and subsequent survival and follow-up periods to monitor outcomes in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed HER2-positive advanced breast cancer that is not amenable to radical surgery.
Not a fit: Patients with HER2-negative breast cancer or those who cannot tolerate chemotherapy or anti-HER2 therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment combination could offer a new effective option for patients with HER2-positive advanced breast cancer.
How similar studies have performed: While this approach is being explored in this specific combination, similar studies have shown promise in treating HER2-positive breast cancer with targeted therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years; 2. The HER2 positive advanced breast cancer confirmed by cytology or histology must meet the following conditions at the same time: (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: 1. Pregnant or lactating women; 2. At the same time or in the past five years, patients with one or more malignant tumors with metastatic capacity or potential other than HER2 positive breast cancer, but not including cured cervical carcinoma in situ, thyroid cancer, skin basal cell carcinoma or squamous cell carcinoma. For other malignant tumors occurring within a period of more than 5 years from this treatment, if only cured by surgery, they are allowed to be included. 3. Persons with a known history of allergy to the drug components of this protocol; 4. Have a history of immunodeficiency, including HIV testing positive, or have other acquired or congenital immunodeficiency diseases; 5. The researcher believes that it is not suitable for inclusion.
Where this trial is running
Hangzhou, Zhejiang
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Chen zhanhong — Zhejiang Cancer Hospital
- Study coordinator: Chen zhanhong
- Email: czred@sina.com
- Phone: +8613606505124
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.