HER2-positive Metastatic Breast CancerNCT06305702
Real-world Study of Inetetamab in HER2-positive Metastatic Breast Cancer
An observational study of HER2-positive Metastatic Breast Cancer, run by Liaoning Cancer Hospital & Institute at 1 site in China.
Trial summary
A multicenter real-world study was conducted to gather clinicopathological data from patients with HER2-positive metastatic breast cancer who were treated with inetetamab between 2022 and 2023. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-positive Metastatic Breast Cancer
- What is being tested?
- inetetamab
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: HER2 Positive Advanced Breast Cancer patients who have received Inetetamab treatment in the metastatic setting.
Who may be able to join
- An age of at least 18 years or older
- Pathologically diagnosed with HER2-positive recurrent or metastatic breast cancer
- Having at least one measurable lesion as defined
- Receiving inetetamab-based therapy in the recurrent or metastatic stage
- Having traceable medical history records
Who cannot join
- Pregnant or lactating women
- Patients with other conditions deemed unsuitable for participating in this study by the researcher
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Real-world Clinical Study of Inetetamab-based Therapy in HER2-positive Metastatic Breast Cancer
A multicenter real-world study was conducted to gather clinicopathological data from patients with HER2-positive metastatic breast cancer who were treated with inetetamab between 2022 and 2023. The study aimed to estimate the progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs) associated with inetetamab therapy.
- Conditions
- HER2-positive Metastatic Breast Cancer
- Being tested
- inetetamab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inetetamabDrug
8mg/kg iv day 1 followed by 6mg/kg iv day 1, cycled every 21 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival(PFS)
Measured: 12 months
Secondary outcomes (2)
objective response rate (ORR)
Measured: 12 months
Adverse events (AEs)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Jul 2022
- Primary completion31 Dec 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaoning Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305702
- Sponsor's protocol ID
- LZRXN-001
- Status last verified
- Feb 2024
- First submitted
- 5 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Our plan is to disseminate the findings of this trial via peer-reviewed articles.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Real-world Clinical Study of Inetetamab-based Therapy in HER2-positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06305702
- Acronym / sponsor ID
- LZRXN-001
- Conditions
- HER2-positive Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Liaoning Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter real-world study was conducted to gather clinicopathological data from patients with HER2-positive metastatic breast cancer who were treated with inetetamab between 2022 and 2023. The study aimed to estimate the progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs) associated with inetetamab therapy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HER2 Positive Advanced Breast Cancer patients who have received Inetetamab treatment in the metastatic setting.
Key inclusion criteria (5 listed)
- An age of at least 18 years or older
- Pathologically diagnosed with HER2-positive recurrent or metastatic breast cancer
- Having at least one measurable lesion as defined
- Receiving inetetamab-based therapy in the recurrent or metastatic stage
- Having traceable medical history records
Key exclusion criteria (2 listed)
- Pregnant or lactating women
- Patients with other conditions deemed unsuitable for participating in this study by the researcher
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inetetamab8mg/kg iv day 1 followed by 6mg/kg iv day 1, cycled every 21 days | Drug | – |
Primary outcome
Progression Free Survival(PFS)
Time frame: 12 months
2 secondary outcomes
objective response rate (ORR)
Time frame: 12 months
Adverse events (AEs)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Undecided. Our plan is to disseminate the findings of this trial via peer-reviewed articles.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2-positive Metastatic Breast Cancer, run by Liaoning Cancer Hospital & Institute 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 12 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival(PFS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2024.