Clinical trial · Interventional
The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive
- 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)
Research object：Planned to receive pyrrolidine for HER2 positive first-line breast cancer patients Research purpose: Main research objectives: To observe the efficacy and safety of pyrrolidine in the treatment of HER2 positive advanced first-line breast cancer. Secondary research objectives: 1. Evaluate the correlation between patient characteristics in the late stage of treatment and specific treatment plans and clinical outcomes Sex (including safety outcomes) 2. Evaluate whether and how previous anti HER2 therapy affects the efficacy of subsequent pyrrolitinib treatment 3. To observe the efficacy of pyrrolitinib in patients with brain metastasis of HER2 positive breast cancer Research endpoint: Main research endpoint: Progression free survival (rwPFS) Secondary study endpoint: Efficacy endpoints: objective response rate (rwORR), disease control rate (rwDCR), until treatment failure Time to Flight (TTF), Total Survival (OS), Security
Conditions
Conditions (3)
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 |
| Pyrotinib | — | UNRESOLVED | — |
| RWS | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pyrotinib | Drug | Pyrotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Pyrotinib
- interventionNames
- Drug: Pyrotinib
Primary outcomes (1)
- measure
- PFS
- timeFrame
- 24.3months
- description
- The time from randomization to disease progression evaluated by researchers for patients
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years old; 2. Pathological or histopathological confirmed HER2 positive cases cannot be surgically advanced or metastasized Patients with sexual breast cancer (HER2 positive is defined as: standard immunohistochemistry (IHC) Detected as 3+or ISH positive); 3. There is a traceable medical history record during the treatment period; 4. Voluntarily participate in this study, sign informed consent, have good compliance, and are willing to cooperate Follow up. Exclusion Criteria: 1. Failure to sign informed consent form; 2. Previous history of other malignant tumors, but cured skin basal cell carcinoma and cervical cancer Excluding cancer; 3. Difficulty in swallowing, chronic diarrhea, and intestinal obstruction, which can affect medication administration and absorption Various factors; 4. Pregnant or lactating women, and women of childbearing age who cannot achieve optimal contraception; 5. Any other circumstances in which the researcher deems the patient unsuitable to participate in this study.
References
Publications (0)
Data not yet available