NCT07180082RecruitingPhase 2
Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer
Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer: a Prospective, Randomized, Controlled, Multicentre Clinical Trial
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
This is a prospective, randomised, controlled, multicentre study to evaluate the efficacy and safety of continuous versus intermittent pyrotinib therapy in patients with human epidermal growth factor receptor (HER2)-positive advanced breast cancer.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 186 (estimated)
- First submitted
- 11 Sept 2025
- Start date
- 28 Aug 2025
- Primary completion date
- Sept 2028
- Lead sponsor
- Wenjin Yin
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07180082
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 186
- From 28 Aug 2025 to the primary completion date, Sept 2028
- 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
- During pregnancy and lactation
- Difficulties with pyrotinib administration or absorption
Who the study is looking for
- Age≥18 years old
- Pathologically confirmed advanced or locally advanced breast cancer not amenable to curative surgery
- Pathologically confirmed HER2+ at least once for either primary or metastatic lesion
- Previously treated with any number of lines for advanced disease and eligible for a pyrotinib-containing regimen at the discretion of physician
- At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1
- ECOG 0-1
- Adequate organ function
Age in the registry: 18 years to - · Sex: All · 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, School of Medicine, Shanghai Jiaotong University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.