HER2-positive Breast CancerNCT04609540
Pyrotinib Combined With Trastuzumab And Chemotherapy in HER2-positive MBC
An observational study of HER2-positive Breast Cancer and Metastatic Breast Cancer, run by Shandong Cancer Hospital and Institute.
Trial summary
To explore the real world data of trastuzumab Combined With Trastuzumab And Chemotherapy in China, and to explore the relationship between progression free survival and treatment pattern. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- HER2-positive Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- Trastuzumab
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 1 Jun 2022
- 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 positive Metastatic Breast Cancer
Who may be able to join
- woman, age > 18 years old
- Diagnosed with HER2 +Metastatic Breast Cancer
- Pyrotinib Combined With Trastuzumab And Chemotherapy for at least one cycle, starting from 2020.11.01-2021.10.31
- Available medical history
Who cannot join
- Incomplete medical history
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pyrotinib Combined With Trastuzumab and Chemotherapy in HER2-positive Metastatic Breast Cancer Patients- a Multicenter Retrospective Study
To explore the real world data of trastuzumab Combined With Trastuzumab And Chemotherapy in China, and to explore the relationship between progression free survival and treatment pattern.
- Being tested
- Trastuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
Also called Pyrotinib
Dual anti-HER2 therapy
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib and Trastuzumab group | Dual anti-HER2 therapy (pyrotinib and trastuzumab) and chemotherapy Receives: Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival(PFS)
The time from starting pyrotinib until disease progression or death from any cause.
Measured: 1 year
Secondary outcomes (3)
Overall survival(OS)
The time from starting pyrotinib until death, regardless of cause.
Measured: 1 year
Objective Response Rate(ORR)
The proportion of patients with complete response (CR) or partial response (PR)
Measured: 1 year
Safety
Number of participants with adverse events which were collected at 6 and 18 months after the start of pyrotinib
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HER2-positive 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiyong Yu, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609540
- Sponsor's protocol ID
- ShandongCHI-14
- Status last verified
- Oct 2020
- First submitted
- 24 Oct 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang L, Li C, Song S, Wang F, Ding T, Liu Z, Jin Y, Yu Z. A real-world comparison study of the efficacy of dual-target first-line rescue treatment of human epidermal growth factor receptor 2 positive advanced breast cancer: trastuzumab combined with pertuzumab versus trastuzumab combined with pyrotinib. Front Oncol. 2026 Mar 4;16:1720851. doi: 10.3389/fonc.2026.1720851. eCollection 2026.
PubMed 41858362
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pyrotinib Combined With Trastuzumab and Chemotherapy in HER2-positive Metastatic Breast Cancer Patients- a Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT04609540
- Acronym / sponsor ID
- ShandongCHI-14
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 30 Oct 2020 (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.
To explore the real world data of trastuzumab Combined With Trastuzumab And Chemotherapy in China, and to explore the relationship between progression free survival and treatment pattern.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyrotinib and Trastuzumab group | – | Drug: TrastuzumabDual anti-HER2 therapy (pyrotinib and trastuzumab) and chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HER2 positive Metastatic Breast Cancer
Key inclusion criteria (4 listed)
- woman, age > 18 years old
- Diagnosed with HER2 +Metastatic Breast Cancer
- Pyrotinib Combined With Trastuzumab And Chemotherapy for at least one cycle, starting from 2020.11.01-2021.10.31
- Available medical history
Key exclusion criteria (1 listed)
- Incomplete medical history
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 |
|---|---|---|
| TrastuzumabAlso: PyrotinibDual anti-HER2 therapy | Drug | Pyrotinib and Trastuzumab group |
Primary outcome
Progression free survival(PFS)
Time frame: 1 year
The time from starting pyrotinib until disease progression or death from any cause.
3 secondary outcomes
Overall survival(OS)
Time frame: 1 year
Objective Response Rate(ORR)
Time frame: 1 year
Safety
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Derived from this study: PubMed 41858362Zhang L, Li C, Song S, Wang F, Ding T, Liu Z, Jin Y, Yu Z. A real-world comparison study of the efficacy of dual-target first-line rescue treatment of human epidermal growth factor receptor 2 positive advanced breast cancer: trastuzumab combined with pertuzumab versus trastuzumab combined with pyrotinib. Front Oncol. 2026 Mar 4;16:1720851. doi: 10.3389/fonc.2026.1720851. eCollection 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2-positive Breast Cancer and Metastatic Breast Cancer, run by Shandong Cancer Hospital and Institute.
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 16 Dec 2020. 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, PhD (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: 1 year). 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 NCT04609540, which also lists 1 linked publication.
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 16 Dec 2020.