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HER2-positive Advanced Breast CancerHER2-VIPNCT05856383

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

An observational study of HER2-positive Advanced Breast Cancer, run by Zhejiang Cancer Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HER2-positive Advanced Breast Cancer
What is being tested?
Inetetamab Combined With Pyrotinib and Vinorelbine
How many people
100 participants
Where
1 siteChina
Study dates
16 Mar 2022to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients with HER2 positive dvanced breast cancer.

Who may be able to join

  • Age ≥ 18 years;
  • The HER2 positive advanced breast cancer confirmed by cytology or histology must meet the following conditions at the same time:
  • 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.

Who cannot join

  • 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;
  • The researcher believes that it is not suitable for inclusion.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chen zhanhong contact

+8613606505124

czred@sina.com

China1 site, 1 recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Chen zhanhong, 13606505124, czred@sina.com

    Recruiting

Other trials in China

About this study

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

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.

Read the detailed description

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.

Being tested
Inetetamab Combined With Pyrotinib and Vinorelbine
Keywords
Advanced breast cancer，HER2-positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inetetamab Combined With Pyrotinib and VinorelbineDrug

    Inetetamab Combined With Pyrotinib and Vinorelbine

Study groups in NCT05856383
Study groupRoleWhat they receive
Group of ues of inetetamab combined with pyrotinib and vinorelbineGroup of ues of inetetamab combined with pyrotinib and vinorelbine
Receives: Drug: Inetetamab Combined With Pyrotinib and Vinorelbine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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

    Measured: assessed up to 48 months

Secondary outcomes (3)

  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.

    Measured: 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.

    Measured: 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.

    Measured: up to 48 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2023
  2. Study start16 Mar 2022
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05856383
Sponsor's protocol ID
ZCHBC024
Acronym
HER2-VIP
Status last verified
May 2023
First submitted
2 Apr 2023
Last updated
12 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 31430226

  • 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.

    PubMed 33581774

Questions about this trial

What is this clinical trial studying?

An observational study of HER2-positive Advanced Breast Cancer, run by Zhejiang Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chen zhanhong (+8613606505124, czred@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progressive free survival(PFS) (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05856383, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.

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