Clinical trial · Interventional
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
ve Study of Diarrhea Tolerance of Pyrotinib Combined With Trastumab and Taxane in the First-line Treatment of HER2-positive Advanced Breast Cancer
NCT06362096CI-TRIAL-00075997unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To explore a reasonable and effective way to reduce the incidence of grade 3 or above diarrhea caused by pyrotinib
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trastuzumab+pyrotinib+taxene | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ARM1
- interventionNames
- Drug: Trastuzumab+pyrotinib+taxene
Primary outcomes (1)
- measure
- Incidence of ≥ grade 3 diarrhea
- timeFrame
- Up to 2 years
- description
- Incidence of ≥ grade 3 diarrhea
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. aged ≥ 18 years, ≤75 years 2. 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. 3. Did not receive any systemic antitumor therapy in the advanced stage; 4. At least one measurable lesion was present according to RECIST1.1 criteria. 5. The ECOG score is 0 to 1 6. The functional major organs must be normal 7. Volunteer to participate in this study, sign informed consent, have good compliance and willing to cooperate with follow-up Exclusion Criteria: 1. Have received any systematic antitumor therapy at the recurrence/metastasis stage; 2. Tyrosine kinase inhibitor (TKI) formulations targeting HER have been used at any stage of breast cancer 3. Patients judged by the investigators to be unsuitable for systematic chemotherapy. 4. Patients with active brain metastases (meaning those requiring mannitol treatment or with symptomatic brain metastases); 5. Had undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or were expected to undergo major surgical treatment. 6. Serious heart disease or discomfort 7. Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect the use and absorption of medications.
References
Publications (0)
Data not yet available
No reference posted for this study.