Combining inetetamab, pyrotinib, and vinorelbine for treating advanced HER2-positive breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Treatment for locally advanced HER2-positive breast cancer using a combination of drugs

  This study is testing a new combination of drugs to see if it can help women with locally advanced HER2-positive breast cancer get better before surgery.

  Recruiting First Affiliated Hospital of Wenzhou Medical University · Wenzhou, Zhejiang · NCT06234137

• Neoadjuvant Pyrotinib-to-pertuzumab for HER2-positive early breast cancer

  This trial tests whether a two-step neoadjuvant plan with Pyrotinib plus Trastuzumab and Docetaxel followed by Pertuzumab plus Trastuzumab and Docetaxel works better than four cycles of Pertuzumab plus Trastuzumab and Docetaxel in women with HER2-positive early- to locally advanced breast cancer.

  Recruiting Phase 3 Shanghai Jiao Tong University School of Medicine · Shanghai · NCT07797218

• Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure

  This study tests whether adding entinostat to pyrotinib and hormone therapy is safe and helps patients with advanced HR+/HER2+ breast cancer who progressed after trastuzumab.

  Recruiting Phase 1/2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07708194

• Pyrotinib plus trastuzumab and chemotherapy for HER2-positive early breast cancer

  This study tests a treatment combination of Pyrotinib, Trastuzumab and chemo given before surgery to see if it can improve responses in HER2-positive breast cancer patients who have not yet been treated.

  Recruiting Phase 2 Hebei Medical University Fourth Hospital · Shijiazhuang, Hebei · NCT07635342

• Pyrotinib and Trastuzumab with Dalpiciclib vs with Docetaxel in advanced HER2-positive breast cancer

  This study tests whether an oral regimen of pyrotinib + subcutaneous trastuzumab + dalpiciclib works as well as the standard IV regimen with docetaxel in people with advanced HER2-positive breast cancer who have limited prior treatment.

  Recruiting Phase 3 Fudan University · Shanghai, Shanghai Municipality · NCT07615751

• Pyrotinib-based regimens for advanced HER2-positive breast cancer: real-world sequential therapy after progression

  This real-world study tests whether giving disitamab vedotin after pyrotinib-based treatment helps people with advanced HER2-positive breast cancer.

  Recruiting Phase 4 Peking University People's Hospital · Beijing, Beijing Municipality · NCT07600164

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.