Breast CancerNCT05572645
Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab
An observational study of Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pyrotinib Plus Trastuzumab and Pertuzumab Plus Trastuzumab
- How many people
- 333 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 1 Sep 2023
- 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: Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage
Who may be able to join
- HER2+ MBC patients scored +3 by immunohistochemical (IHC) analysis or scored +2 and the result of fluorescence in situ hybridization was positive.
- Patients received Pyrotinib(320-400 mg, po, qd) plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) or Pertuzumab(840mg q3w, and then 420 mg q3w) plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) for at least one cycle, starting from Jan 2018 to Sep 2022.
- Patients had complete medical records. All data were retrospectively collected from medical records of individual institutions.
Who cannot join
- Incomplete medical history
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab in HER2-Positive Metastatic Breast Cancer: a Multicenter, Retrospective Study
Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab
Read the detailed description
This is a retrospective study aiming to explore the efficacy and safety of Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab in patients with HER2-positive metastatic breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Pyrotinib Plus Trastuzumab, Pertuzumab Plus Trastuzumab
- Keywords
- Pyrotinib, Trastuzumab, Pertuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyrotinib Plus TrastuzumabDrug
treatment based on Pyrotinib(320-400 mg, po, qd) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w)
Pertuzumab Plus TrastuzumabDrug
treatment based on Pertuzumab(840mg q3w, and then 420 mg q3w) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w)
| Study group | Role | What they receive |
|---|---|---|
| PyroH | treatment based on Pyrotinib(320-400 mg, po, qd) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) Receives: Drug: Pyrotinib Plus Trastuzumab | |
| PertH | treatment based on Pertuzumab(840mg q3w, and then 420 mg q3w) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) Receives: Drug: Pertuzumab Plus Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression free survival
Measured: 6 weeks
Secondary outcomes (1)
Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 Oct 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan 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
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Biyun Wang, MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572645
- Sponsor's protocol ID
- YOUNGBC-21
- Status last verified
- Feb 2024
- First submitted
- 5 Oct 2022
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
You S, Xie Y, Sang D, Luo T, Yuan P, Xu F, Wang B. Comparing pyrotinib with trastuzumab and pertuzumab with trastuzumab for HER2-positive metastatic breast cancer: a retrospective, multicenter analysis. Front Endocrinol (Lausanne). 2023 Dec 11;14:1325540. doi: 10.3389/fendo.2023.1325540. eCollection 2023.
PubMed 38149099
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab in HER2-Positive Metastatic Breast Cancer: a Multicenter, Retrospective Study
- ClinicalTrials.gov ID
- NCT05572645
- Acronym / sponsor ID
- YOUNGBC-21
- Conditions
- Breast Cancer
- Keywords
- Pyrotinib, Trastuzumab, Pertuzumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 10 Oct 2022 (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.
Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab
Detailed description
This is a retrospective study aiming to explore the efficacy and safety of Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab in patients with HER2-positive metastatic breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PyroH | – | Drug: Pyrotinib Plus Trastuzumabtreatment based on Pyrotinib(320-400 mg, po, qd) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) |
| PertH | – | Drug: Pertuzumab Plus Trastuzumabtreatment based on Pertuzumab(840mg q3w, and then 420 mg q3w) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage
Key inclusion criteria (3 listed)
- HER2+ MBC patients scored +3 by immunohistochemical (IHC) analysis or scored +2 and the result of fluorescence in situ hybridization was positive.
- Patients received Pyrotinib(320-400 mg, po, qd) plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) or Pertuzumab(840mg q3w, and then 420 mg q3w) plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) for at least one cycle, starting from Jan 2018 to Sep 2022.
- Patients had complete medical records. All data were retrospectively collected from medical records of individual institutions.
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 |
|---|---|---|
| Pyrotinib Plus Trastuzumabtreatment based on Pyrotinib(320-400 mg, po, qd) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) | Drug | PyroH |
| Pertuzumab Plus Trastuzumabtreatment based on Pertuzumab(840mg q3w, and then 420 mg q3w) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) | Drug | PertH |
Primary outcome
PFS
Time frame: 6 weeks
Progression free survival
1 secondary outcome
Adverse Events
Time frame: 6 weeks
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 26 Feb 2024.
- Derived from this study: PubMed 38149099You S, Xie Y, Sang D, Luo T, Yuan P, Xu F, Wang B. Comparing pyrotinib with trastuzumab and pertuzumab with trastuzumab for HER2-positive metastatic breast cancer: a retrospective, multicenter analysis. Front Endocrinol (Lausanne). 2023 Dec 11;14:1325540. doi: 10.3389/fendo.2023.1325540. eCollection 2023.
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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 Fudan 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 3 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: finished, as of the sponsor's last update on 26 Feb 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?
PFS (time frame: 6 weeks). 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 NCT05572645, 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 26 Feb 2024.