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

ConditionHER2-positive Advanced Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZhejiang Cancer Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years;

Disqualifiers

Pregnant or lactating women;

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;

Trial population

patients with HER2 positive dvanced breast cancer.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Inetetamab Combined With Pyrotinib and Vinorelbine

    Drug

    Inetetamab Combined With Pyrotinib and Vinorelbine

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Group of ues of inetetamab combined with pyrotinib and vinorelbine1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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
2

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

Time frame
assessed up to 48 months

Secondary outcomes

1

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.

Time frame
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.
2

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.

Time frame
up to 48 months.
3

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.

Time frame
up to 48 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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