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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.