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NCT05856383Recruiting

Efficacy and Safety of Inetetamab Combined With Pyrotinib and Vinorelbine in ABC

Efficacy and Safety of Inetetamab Combined With Pyrotinib and Vinorelbine in the Treatment of Advanced Breast Cancer

Source: ClinicalTrials.gov · Last updated 12 May 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
2 Apr 2023
Start date
16 Mar 2022
Primary completion date
31 Dec 2027
Lead sponsor
Zhejiang Cancer Hospital
NCT number
NCT05856383

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 16 Mar 2022 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.
  • Persons with a known history of allergy to the drug components of this protocol;
  • Have a history of immunodeficiency, including HIV testing positive, or have other acquired or congenital immunodeficiency diseases;

Other

  • Pregnant or lactating women;
  • The researcher believes that it is not suitable for inclusion.

Who the study is looking for

  • Age ≥ 18 years;
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zhejiang Cancer Hospital
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.