Breast CancerPhase 2NCT06362096
A Multicenter, Prospective Study of Diarrhea Tolerance of Pyrotinib Combined With Trastumab and Taxane in the First-line Treatment of HER2-positive Advanced Breast Cancer
A Phase 2 study testing Trastuzumab+pyrotinib+taxene in people with Breast Cancer, run by Huihua Xiong.
Trial summary
To explore a reasonable and effective way to reduce the incidence of grade 3 or above diarrhea caused by pyrotinib Read more about this study
- Who is it for?
- Ages 17 to 75 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Trastuzumab+pyrotinib+taxene
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- May 2024to May 2026
- 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 17 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- aged ≥ 18 years, ≤75 years
- Her2-positive recurrent or metastatic breast cancer; Patients with local recurrence need to be confirmed by the investigator that radical surgical resection is not possible.
- Did not receive any systemic antitumor therapy in the advanced stage;
- At least one measurable lesion was present according to RECIST1.1 criteria.
- The ECOG score is 0 to 1
- The functional major organs must be normal
- Volunteer to participate in this study, sign informed consent, have good compliance and willing to cooperate with follow-up
Who cannot join
- Have received any systematic antitumor therapy at the recurrence/metastasis stage;
- Tyrosine kinase inhibitor (TKI) formulations targeting HER have been used at any stage of breast cancer
- Patients judged by the investigators to be unsuitable for systematic chemotherapy.
- Patients with active brain metastases (meaning those requiring mannitol treatment or with symptomatic brain metastases);
- Had undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or were expected to undergo major surgical treatment.
- Serious heart disease or discomfort
- Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect the use and absorption of medications.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: ve Study of Diarrhea Tolerance of Pyrotinib Combined With Trastumab and Taxane in the First-line Treatment of HER2-positive Advanced Breast Cancer
To explore a reasonable and effective way to reduce the incidence of grade 3 or above diarrhea caused by pyrotinib
- Conditions
- Breast Cancer
- Being tested
- Trastuzumab+pyrotinib+taxene
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab+pyrotinib+taxeneDrug
Trastuzumab (first cycle 8mg/Kg, subsequent 6mg/Kg, iv, q3w) Pyrrotinib * po, qd, q3w The first cycle 240mg+ montmorillonite powder, the second cycle 320mg+ montmorillonite powder prevention Subsequent cycle 400mg+* montmorillonite powder used when necessary taxenes
| Study group | Role | What they receive |
|---|---|---|
| ARM1 | Experimental | Not described Receives: Drug: Trastuzumab+pyrotinib+taxene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ≥ grade 3 diarrhea
Incidence of ≥ grade 3 diarrhea
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 posted12 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2026 (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.
- 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huihua Xiong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huihua Xiong, Tongji Hospital
- Investigators
- Xiong huihua, Principal investigator, Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362096
- Sponsor's protocol ID
- pyrotinib diarrhra
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ve Study of Diarrhea Tolerance of Pyrotinib Combined With Trastumab and Taxane in the First-line Treatment of HER2-positive Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT06362096
- Acronym / sponsor ID
- pyrotinib diarrhra
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Huihua XiongUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 12 Apr 2024 (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 a reasonable and effective way to reduce the incidence of grade 3 or above diarrhea caused by pyrotinib
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARM1 | Experimental | Drug: Trastuzumab+pyrotinib+taxene |
Who may qualify
- Ages
- 17 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- aged ≥ 18 years, ≤75 years
- Her2-positive recurrent or metastatic breast cancer; Patients with local recurrence need to be confirmed by the investigator that radical surgical resection is not possible.
- Did not receive any systemic antitumor therapy in the advanced stage;
- At least one measurable lesion was present according to RECIST1.1 criteria.
- The ECOG score is 0 to 1
Key exclusion criteria (7 listed)
- Have received any systematic antitumor therapy at the recurrence/metastasis stage;
- Tyrosine kinase inhibitor (TKI) formulations targeting HER have been used at any stage of breast cancer
- Patients judged by the investigators to be unsuitable for systematic chemotherapy.
- Patients with active brain metastases (meaning those requiring mannitol treatment or with symptomatic brain metastases);
- Had undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or were expected to undergo major surgical treatment.
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 |
|---|---|---|
| Trastuzumab+pyrotinib+taxeneTrastuzumab (first cycle 8mg/Kg, subsequent 6mg/Kg, iv, q3w) Pyrrotinib * po, qd, q3w The first cycle 240mg+ montmorillonite powder, the second cycle 320mg+ montmorillonite powder prevention Subsequent cycle 400mg+* montmorillonite powder used when necessary taxenes | Drug | ARM1 |
Primary outcome
Incidence of ≥ grade 3 diarrhea
Time frame: Up to 2 years
Incidence of ≥ grade 3 diarrhea
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Xiong huihua principal investigator
Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab+pyrotinib+taxene in people with Breast Cancer, run by Huihua Xiong.
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 12 Apr 2024. 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?
Contact Xiong huihua (13886073988, xionghuihua@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ≥ grade 3 diarrhea (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 12 Apr 2024.