Advanced Breast CancerPhase 2NCT05255523
Pyrotinib Plus Trastuzumab After First-line TH (P) Treatment With HER-2 Positive Breast Cancer
A Phase 2 study testing pyrotinib in people with Advanced Breast Cancer, run by Fujian Medical University Union Hospital.
Trial summary
The purpose of this study is to assess the effect of pyrotinib Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- pyrotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2022to 20 Dec 2024
- Phase
- Phase 2
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age:18-75 years old, female;
- HER2 positive advanced breast cancer diagnosed by pathology, cytology or radiology, including inoperable breast cancer with stage IV, or recurrent/metastatic breast cancer.HER-2 positivity was confirmed by histopathological test: immunohistochemistry(IHC) results of 3 + or in situ hybridization (ISH) results of amplification of HER2;
- Disease progression occurs after treatment with trastuzumab (stopping the drug for more than 12 months) or newly diagnosed IV stage breast cancer patients;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Life expectancy greater than or equal to 6 months;
- The main organs function well, and the inspection indicators meet the following requirements:
- 1) For results of blood routine test HB≥90g/L; ANC≥1.5×109/L; PLT≥90×109/L; 2) For results of blood biochemical test ALT and AST≤2×ULN, but≤5×ULN if the transferanse elevation is due to liver metastases； TBIL≤1.5×ULN； Serum creatinine ≤1.5×ULN; 7. The researchers believed that the subjects were preference to benefit; 8. Participants were willing to join in this study, and written informed consent.
Who cannot join
- Patients with brain metastases by CT or MRI;
- More factors affecting of oral drugs (gastrointestinal surgery history, inability to swallow, chronic diarrhea, intestinal obstruction);
- Study drug and excipient allergy;
- History of psychiatric drugs abuse and can't quit or patients with mental disorders;
- Pregnant or lactating female patients;
- Less than 4 weeks from the last clinical trial;
- The researchers think inappropriate.
About this study
Official title: A Single Arm，Multicenter，Real-world Observational Study of Pyrotinib Plus Trastuzumab After First-line TH (P) Treatment With HER-2 Positive Breast Cancer
The purpose of this study is to assess the effect of pyrotinib
Read the detailed description
The purpose of this study is to assess the effect of pyrotinib combined with trastuzumab in the maintenance phase delay/reduction of brain metastases after first-line TH(P) therapy for HER-2-positive advanced breast cancer
- Conditions
- Advanced Breast Cancer
- Being tested
- pyrotinib
- Keywords
- pyrotinib;CNS;breast cancer; HER-2 positivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyrotinibDrug
Also called capecitabine
After 4-6 cycles of taxane chemotherapeutics combined with trastuzumab±pertuzumab, the assessment result reaches CR or PR, and the subsequent sequential pyrrotinib plus capecitabine±trastuzumab to CNS Progress
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Pyrotinib：400mg qd po continuous medication Capecitabine: 1000 mg/m2 bid po for 14 consecutive days with 7 days off, every 21 days as a cycle. Receives: Drug: pyrotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of first progression with brain metastases
Incidence of first progression with brain metastases
Measured: 24 month
Secondary outcomes (2)
ORR without CNS
Baseline to measured stable disease without central nervous system
Measured: 24 month
TTBM
Time to brain metastases
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start20 Feb 2022 (estimated)
- Primary completion5 Nov 2023 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255523
- Sponsor's protocol ID
- 001
- Status last verified
- Feb 2022
- First submitted
- 16 Feb 2022
- Last updated
- 24 Feb 2022
- 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 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm，Multicenter，Real-world Observational Study of Pyrotinib Plus Trastuzumab After First-line TH (P) Treatment With HER-2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT05255523
- Acronym / sponsor ID
- 001
- Conditions
- Advanced Breast Cancer
- Keywords
- pyrotinib;CNS;breast cancer; HER-2 positivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 20 Feb 2022 (estimated)
- Primary completion
- 5 Nov 2023 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 24 Feb 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.
The purpose of this study is to assess the effect of pyrotinib
Detailed description
The purpose of this study is to assess the effect of pyrotinib combined with trastuzumab in the maintenance phase delay/reduction of brain metastases after first-line TH(P) therapy for HER-2-positive advanced breast cancer
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: pyrotinibPyrotinib：400mg qd po continuous medication Capecitabine: 1000 mg/m2 bid po for 14 consecutive days with 7 days off, every 21 days as a cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age:18-75 years old, female;
- HER2 positive advanced breast cancer diagnosed by pathology, cytology or radiology, including inoperable breast cancer with stage IV, or recurrent/metastatic breast cancer.HER-2 positivity was confirmed by histopathological test: immunohistochemistry(IHC) results of 3 + or in situ hybridization (ISH) results of amplification of HER2;
- Disease progression occurs after treatment with trastuzumab (stopping the drug for more than 12 months) or newly diagnosed IV stage breast cancer patients;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Life expectancy greater than or equal to 6 months;
Key exclusion criteria (7 listed)
- Patients with brain metastases by CT or MRI;
- More factors affecting of oral drugs (gastrointestinal surgery history, inability to swallow, chronic diarrhea, intestinal obstruction);
- Study drug and excipient allergy;
- History of psychiatric drugs abuse and can't quit or patients with mental disorders;
- Pregnant or lactating female patients;
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 |
|---|---|---|
| pyrotinibAlso: capecitabineAfter 4-6 cycles of taxane chemotherapeutics combined with trastuzumab±pertuzumab, the assessment result reaches CR or PR, and the subsequent sequential pyrrotinib plus capecitabine±trastuzumab to CNS Progress | Drug | Arm 1 |
Primary outcome
Incidence of first progression with brain metastases
Time frame: 24 month
Incidence of first progression with brain metastases
2 secondary outcomes
ORR without CNS
Time frame: 24 month
TTBM
Time frame: 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pyrotinib in people with Advanced Breast Cancer, run by Fujian Medical University Union Hospital.
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 7 inclusion and 7 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 24 Feb 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Incidence of first progression with brain metastases (time frame: 24 month). 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 24 Feb 2022.