HER2-positive Advanced Breast CancerNCT04963608
RWS of Inetetamab HER2 Positive Advanced Breast Cancer
An observational study of HER2-positive Advanced Breast Cancer, run by Zhiyong Yu.
Trial summary
This non-Interventional study will describe and analyze the clinical use of Inetetamab in clinical practice in the treatment of HER2 positive advanced breast cancer in the real world. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- HER2-positive Advanced Breast Cancer
- What is being tested?
- Inetetamab
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2021to Dec 2021
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: HER2+ advanced breast cancer patients whose treatment decision with Inetetamab has been made by their physician and who meet the eligibility criteria will be invited to participate in the study
Who may be able to join
- Patients with stage IV breast cancer
- Patients with HER2 positive status
- Patients that received Inetetamab
- Patients that began Inetetamab therapy prior to June 30, 2021.
Who cannot join
- Patients treated with an investigational anticancer agent Inetetamab
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Real World Study of Inetetamab HER2 Positive Advanced Breast Cancer
This non-Interventional study will describe and analyze the clinical use of Inetetamab in clinical practice in the treatment of HER2 positive advanced breast cancer in the real world.
- Conditions
- HER2-positive Advanced 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
| Study group | Role | What they receive |
|---|---|---|
| non-interventional study | Her2 positive ABC patients who have received Inetetamab in the metastatic setting. Receives: Drug: Inetetamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival(PFS)
Measured: 12 months
Incidences of adverse events and toxicities
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 posted15 Jul 2021
- Study startJul 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Advanced 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhiyong Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhiyong Yu, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963608
- Sponsor's protocol ID
- RSINETE
- Status last verified
- Jul 2021
- First submitted
- 11 Jul 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The results of this retrospective observational study will not be formally documented in a Clinical Study Report. Coded patient-level data will be shared with the sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Study of Inetetamab HER2 Positive Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT04963608
- Acronym / sponsor ID
- RSINETE
- Conditions
- HER2-positive Advanced Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhiyong YuUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 15 Jul 2021 (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.
This non-Interventional study will describe and analyze the clinical use of Inetetamab in clinical practice in the treatment of HER2 positive advanced breast cancer in the real world.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-interventional study | – | Drug: InetetamabHer2 positive ABC patients who have received Inetetamab in the metastatic setting. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HER2+ advanced breast cancer patients whose treatment decision with Inetetamab has been made by their physician and who meet the eligibility criteria will be invited to participate in the study
Key inclusion criteria (4 listed)
- Patients with stage IV breast cancer
- Patients with HER2 positive status
- Patients that received Inetetamab
- Patients that began Inetetamab therapy prior to June 30, 2021.
Key exclusion criteria (1 listed)
- Patients treated with an investigational anticancer agent Inetetamab
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 | non-interventional study |
Primary outcome
Progression Free Survival(PFS)
Time frame: 12 months
Incidences of adverse events and toxicities
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Individual participant dataSharing planned: Undecided. The results of this retrospective observational study will not be formally documented in a Clinical Study Report. Coded patient-level data will be shared with the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2-positive Advanced Breast Cancer, run by Zhiyong Yu.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiyong yu (86-13355312277, drzhiyongyu@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival(PFS) (time frame: 12 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?
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 15 Jul 2021.