NCT06495541Not yet recruiting
The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive
Source: ClinicalTrials.gov · Last updated 20 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 3 Jul 2024
- Start date
- 1 Apr 2026
- Primary completion date
- 30 Jul 2026
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06495541
What you commit to
- Study type: Interventional
- Planned participants: 500
- From 1 Apr 2026 to the primary completion date, 30 Jul 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Difficulty in swallowing, chronic diarrhea, and intestinal obstruction, which can affect medication administration and absorption Various factors;
Other illness
- Failure to sign informed consent form;
- Previous history of other malignant tumors, but cured skin basal cell carcinoma and cervical cancer Excluding cancer;
Age
- Pregnant or lactating women, and women of childbearing age who cannot achieve optimal contraception;
Other
- Any other circumstances in which the researcher deems the patient unsuitable to participate in this study.
Who the study is looking for
- Age ≥ 18 years old;
- 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);
- There is a traceable medical history record during the treatment period;
- Voluntarily participate in this study, sign informed consent, have good compliance, and are willing to cooperate Follow up.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.