Breast CancerNCT06990347
A Study on the Efficacy and Safety of IPyC for HER2+ MBC
An observational study of Breast Cancer, run by Fujian Medical University at 1 site in China.
Trial summary
Between July 2020 and August 2024, 301 HER2-positive MBC patients from five tertiary centers received the regimen until disease progression or unacceptable toxicity. Efficacy endpoints included progression-free survival (PFS), objective response rate (ORR), and clinical benefit rate (CBR). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Inetetamab and Pyrotinib Combined with Chemotherapy
- How many people
- 301 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 1 May 2025
- 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: Patients from five centers, clinical oncology school of fujian medical university, fujian provincial hospital, the first affiliated hospital of xiamen university, zhangzhou zhengxing hospital and the third affiliated people's hospital of fujian university of traditional chinese medicine
Who may be able to join
- patients who underwent a biopsy of the metastatic site and were confirmed as having MBC
- patients who received inetetamab + pyrotinib + chemotherapy as metastasis therapy.
Who cannot join
- male patients or individuals with prior malignancy
- patients with prior or current enrollment in interventional clinical trials for MBC
- patients who received less than 2 cycles of treatment (6 weeks of inetetamab or 8 weeks of pyrotinib)
- patients who were lost to follow-up during the therapeutic process
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Multicenter Cohort Study on the Efficacy and Safety of Inetetamab and Pyrotinib Combined With Chemotherapy for HER2-positive Metastatic Breast Cancer
Between July 2020 and August 2024, 301 HER2-positive MBC patients from five tertiary centers received the regimen until disease progression or unacceptable toxicity. Efficacy endpoints included progression-free survival (PFS), objective response rate (ORR), and clinical benefit rate (CBR).
- Conditions
- Breast Cancer
- Being tested
- Inetetamab and Pyrotinib Combined with Chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inetetamab and Pyrotinib Combined with ChemotherapyDrug
Inetetamab and Pyrotinib Combined with Chemotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
Measured: 2 years
Secondary outcomes (2)
objective response rate (ORR)
Measured: 2 years
clinical benefit rate (CBR)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Jul 2020
- Primary completion1 Aug 2024
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- 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
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fan Wu, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990347
- Sponsor's protocol ID
- K2024-534-01
- Status last verified
- May 2025
- First submitted
- 18 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Multicenter Cohort Study on the Efficacy and Safety of Inetetamab and Pyrotinib Combined With Chemotherapy for HER2-positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06990347
- Acronym / sponsor ID
- K2024-534-01
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 25 May 2025 (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.
Between July 2020 and August 2024, 301 HER2-positive MBC patients from five tertiary centers received the regimen until disease progression or unacceptable toxicity. Efficacy endpoints included progression-free survival (PFS), objective response rate (ORR), and clinical benefit rate (CBR).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from five centers, clinical oncology school of fujian medical university, fujian provincial hospital, the first affiliated hospital of xiamen university, zhangzhou zhengxing hospital and the third affiliated people's hospital of fujian university of traditional chinese medicine
Key inclusion criteria (2 listed)
- patients who underwent a biopsy of the metastatic site and were confirmed as having MBC
- patients who received inetetamab + pyrotinib + chemotherapy as metastasis therapy.
Key exclusion criteria (4 listed)
- male patients or individuals with prior malignancy
- patients with prior or current enrollment in interventional clinical trials for MBC
- patients who received less than 2 cycles of treatment (6 weeks of inetetamab or 8 weeks of pyrotinib)
- patients who were lost to follow-up during the therapeutic process
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 |
|---|---|---|
| Inetetamab and Pyrotinib Combined with ChemotherapyInetetamab and Pyrotinib Combined with Chemotherapy | Drug | – |
Primary outcome
progression-free survival (PFS)
Time frame: 2 years
2 secondary outcomes
objective response rate (ORR)
Time frame: 2 years
clinical benefit rate (CBR)
Time frame: 2 years
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 25 May 2025.
- Individual participant dataSharing planned: No
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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 Breast Cancer, run by Fujian Medical University 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 2 inclusion and 4 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 25 May 2025. 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: 2 years). 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 25 May 2025.