NCT04126525Active, not recruitingPhase 2
Neoadjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer
NeoAdjuvant Trastuzumab/ Pyrotinib Plus Weekly Paclitaxel/Cisplatin in HER2-positive Locally Advanced Breast Cancer Patients
Source: ClinicalTrials.gov · Last updated 11 Sept 2025
Brief summary (registry, in English)
This is a prospective, open label study to evaluate the efficacy and safety of neoadjuvant pyrotinib in early breast cancer patients.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 53 (actual)
- First submitted
- 6 Oct 2019
- Start date
- 18 Jun 2019
- Primary completion date
- 28 Oct 2021
- Lead sponsor
- RenJi Hospital
- Diseases
- Metastatic breast cancer
- NCT number
- NCT04126525
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 53
- From 18 Jun 2019 to the primary completion date, 28 Oct 2021
- 1 site in 1 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.
Other illness
- Metastatic disease (Stage IV)
- History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation
- Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial
- Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study
Age
- Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test. Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period
Other
- Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption
- Treated or treating with T-DM1, lapatinib and neratinib before study entry
Who the study is looking for
- Female, Aged ≥18 and ≤70 years
- Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ⅡA-Ⅲ)
- Subjects with at least one evaluable lesion
- ECOG 0-1
- Adequate organ function
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| RenJi Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.