Breast CancerNCT05359120
Pyrotinib Combined With Capecitabine in HER-2 Positive Advanced Breast Cancer and Brain Metastases (Post-PERMEATE)
An observational study of Breast Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
This study aims to describe the different treatment time, treatment mode and clinical outcomes of pyrotinib maleate tablets combined with capecitabine in the treatment of patients with HER-2 positive advanced breast cancer with brain metastases. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2022to May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cases of patients with brain metastases from HER2-positive advanced breast cancer who received pyrotinib combined with capecitabine from July 2018 to December 2022.
Who may be able to join
- Pathologically diagnosed patients with HER-2 expression-positive advanced breast cancer; Note: Positive HER2 expression refers to at least one tumor cell immunohistochemical staining intensity of 3+ or fluorescence in situ hybridization [FISH] in the pathological detection/recheck of the primary or metastatic lesions performed by the pathology department of the participating central hospital confirmed positive;
- Brain metastases are diagnosed by MRI/enhanced CT imaging, according to RECIST 1.1 criteria, with or without measurable lesions and with or without symptoms of brain metastases;
- Pyrotinib combined with capecitabine in the treatment of brain metastases with non-PD evaluation at the first treatment, at least ≥ 2 continuous imaging reports or assessments
- For previous treatment regimens, no previous use of capecitabine or progression after capecitabine discontinuation for 6 months, or progression after discontinuation of capecitabine adjuvant therapy for one year or more;
- There are traceable medical history data.
Who cannot join
- Patients enrolled in the previous PERMEATE study;
- The research program is receiving other anti-tumor drug treatment at the same time;
- The initial dose of pyrotinib is lower than the minimum dose in the instructions (240 mg), and the capecitabine is 50% lower than the standard dose;
- Pyrotinib combined with capecitabine in the treatment of non-brain metastases and progressive patients;
- The investigator believes that the patient is not suitable to enter this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan cancer hospital
Zhengzhou, Henan, 450008
Min Yan, Dr, 8615713857388, ym200678@126.com
About this study
Official title: A Nationwide Multicenter, Ambispective Real-world Study of Pyrotinib Combined With Capecitabine in Patients With HER-2 Positive Advanced Breast Cancer and Brain Metastases (Post-PERMEATE)
This study aims to describe the different treatment time, treatment mode and clinical outcomes of pyrotinib maleate tablets combined with capecitabine in the treatment of patients with HER-2 positive advanced breast cancer with brain metastases.
Read the detailed description
This study is a multicenter, observational, real-world study with no formal statistical assumptions and sample size calculations; patient efficacy and safety data will be descriptively analyzed to assess the risk of HER2-positive advanced breast cancer patients with brain metastases. Efficacy of pyrotinib combined with capecitabine regimen in the real world, while evaluating the overall survival benefit of local therapy and drug therapy in patients with brain metastases.
The estimated sample size is 300 cases, and at least one group of cohort A, cohort B and cohort C is planned to exceed 100 cases; Cohort A - patients with new brain metastases directly treated with pyrotinib combined with capecitabine; Cohort B- Whole brain radiotherapy or stereotactic radiotherapy concurrently (≤3 months before and after radiotherapy) with pyrotinib combined with capecitabine; Cohort C - group of patients with pyrotinib plus capecitabine after whole brain radiotherapy or stereotactic radiotherapy (more than 3 months after radiotherapy)。
- Conditions
- Breast Cancer
- Keywords
- HER-2 positive advanced breast cancer, pyrotinib, capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cohort A | new brain metastases directly treated with pyrotinib combined with capecitabine | |
| cohort B | whole brain radiotherapy or stereotactic radiotherapy concurrently (≤3 months before and after radiotherapy) with pyrotinib combined with capecitabine | |
| cohort C | after whole brain radiotherapy or stereotactic radiotherapy (more than 3 months after radiotherapy) treated with pyrotinib combined with capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Failure(TTF)
Time from initiation of study protocol treatment to treatment failure or study protocol discontinuation for any reason (including discontinuation due to patient request, disease progression, adverse events, or death)
Measured: up to 2 years
Secondary outcomes (7)
Progression-free survival(PFS)
Time from initiation of study protocol treatment to disease progression (if occurring within 30 days of end of treatment) or death, as assessed by clinician or with or without radiographic progression.
Measured: up to 2 years
CNS-DCR
The patients began to receive the treatment plan of this study, and during the period of the patients' disease progression group, the number of patients with the best response effect of intracranial lesions in the patient's medical records were objective remission (CR+PR) and stable disease (SD) in the analysis data set. The sum of the percentages of the total population.
Measured: up to 2 years
CNS-CBR
The patient started to receive the treatment plan of this study, and during the period of the patient's disease progression group, the best response effect of intracranial lesions in the patient's medical records was complete remission (CR) + partial remission (PR) + stable disease (SD) ≥ 6 The sum of the month's patient population as a percentage of the total population in the analyzed dataset.
Measured: up to 2 years
CNS-ORR
Among all patients who received pyrotinib plus capecitabine for brain metastases, the proportion of patients with physician-assessed complete remission (CR) or any less than complete remission (documented remission) in the patient's medical records on radiology scans.
Measured: up to 2 years
CNS-DOR
Duration between first scan showing documented remission of intracranial lesions and first scan showing disease progression or end of treatment if no progression occurred. rwDOR was evaluable in patients who received ≥2 consecutive radiology scans.
Measured: up to 2 years
Overall Survival(OS)
The time from the start of treatment with this study protocol to the time of all-cause death of patients.
Measured: up to 2 years
safety
Refers to the proportion of patients with a clinically significant adverse event (AE) (ie, leading to treatment modification or discontinuation, patient hospitalization, death, or permanent sequelae) documented in the medical records.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start30 May 2022
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
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 Henan Cancer HospitalThe 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
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359120
- Sponsor's protocol ID
- HNCH-MBC09-BM03
- Status last verified
- Apr 2022
- First submitted
- 29 Apr 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification are available following article publication
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nationwide Multicenter, Ambispective Real-world Study of Pyrotinib Combined With Capecitabine in Patients With HER-2 Positive Advanced Breast Cancer and Brain Metastases (Post-PERMEATE)
- ClinicalTrials.gov ID
- NCT05359120
- Acronym / sponsor ID
- HNCH-MBC09-BM03
- Conditions
- Breast Cancer
- Keywords
- HER-2 positive advanced breast cancer, pyrotinib, capecitabine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 30 May 2022 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 3 May 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.
This study aims to describe the different treatment time, treatment mode and clinical outcomes of pyrotinib maleate tablets combined with capecitabine in the treatment of patients with HER-2 positive advanced breast cancer with brain metastases.
Detailed description
This study is a multicenter, observational, real-world study with no formal statistical assumptions and sample size calculations; patient efficacy and safety data will be descriptively analyzed to assess the risk of HER2-positive advanced breast cancer patients with brain metastases. Efficacy of pyrotinib combined with capecitabine regimen in the real world, while evaluating the overall survival benefit of local therapy and drug therapy in patients with brain metastases.
The estimated sample size is 300 cases, and at least one group of cohort A, cohort B and cohort C is planned to exceed 100 cases; Cohort A - patients with new brain metastases directly treated with pyrotinib combined with capecitabine; Cohort B- Whole brain radiotherapy or stereotactic radiotherapy concurrently (≤3 months before and after radiotherapy) with pyrotinib combined with capecitabine; Cohort C - group of patients with pyrotinib plus capecitabine after whole brain radiotherapy or stereotactic radiotherapy (more than 3 months after radiotherapy)。
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cohort A | – | –new brain metastases directly treated with pyrotinib combined with capecitabine |
| cohort B | – | –whole brain radiotherapy or stereotactic radiotherapy concurrently (≤3 months before and after radiotherapy) with pyrotinib combined with capecitabine |
| cohort C | – | –after whole brain radiotherapy or stereotactic radiotherapy (more than 3 months after radiotherapy) treated with pyrotinib combined with capecitabine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cases of patients with brain metastases from HER2-positive advanced breast cancer who received pyrotinib combined with capecitabine from July 2018 to December 2022.
Key inclusion criteria (5 listed)
- Pathologically diagnosed patients with HER-2 expression-positive advanced breast cancer; Note: Positive HER2 expression refers to at least one tumor cell immunohistochemical staining intensity of 3+ or fluorescence in situ hybridization [FISH] in the pathological detection/recheck of the primary or metastatic lesions performed by the pathology department of the participating central hospital confirmed positive;
- Brain metastases are diagnosed by MRI/enhanced CT imaging, according to RECIST 1.1 criteria, with or without measurable lesions and with or without symptoms of brain metastases;
- Pyrotinib combined with capecitabine in the treatment of brain metastases with non-PD evaluation at the first treatment, at least ≥ 2 continuous imaging reports or assessments
- For previous treatment regimens, no previous use of capecitabine or progression after capecitabine discontinuation for 6 months, or progression after discontinuation of capecitabine adjuvant therapy for one year or more;
- There are traceable medical history data.
Key exclusion criteria (5 listed)
- Patients enrolled in the previous PERMEATE study;
- The research program is receiving other anti-tumor drug treatment at the same time;
- The initial dose of pyrotinib is lower than the minimum dose in the instructions (240 mg), and the capecitabine is 50% lower than the standard dose;
- Pyrotinib combined with capecitabine in the treatment of non-brain metastases and progressive patients;
- The investigator believes that the patient is not suitable to enter this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to Failure(TTF)
Time frame: up to 2 years
Time from initiation of study protocol treatment to treatment failure or study protocol discontinuation for any reason (including discontinuation due to patient request, disease progression, adverse events, or death)
7 secondary outcomes
Progression-free survival(PFS)
Time frame: up to 2 years
CNS-DCR
Time frame: up to 2 years
CNS-CBR
Time frame: up to 2 years
CNS-ORR
Time frame: up to 2 years
CNS-DOR
Time frame: up to 2 years
Overall Survival(OS)
Time frame: up to 2 years
safety
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification are available following article publication
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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.
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 Henan Cancer Hospital 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 5 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 19 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Yan (15713857388, ym200678@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Failure(TTF) (time frame: up to 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 19 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.