Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer
- Registration Number
- NCT07180082
- Lead Sponsor
- Wenjin Yin
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 186
- 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
- During pregnancy and lactation
- Difficulties with pyrotinib administration or absorption
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intermittent pyrotinib Pyrotinib Intermittent use of pyrotinib, 14 days on and 7 days of, every 21 days Continuous pyroitnib Pyrotinib oral pyrotinib qd
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) From the date of starting pyrotinib to the date of confirmed CR or PR (up to approximately 1 years) ORR is the percentage of subjects with complete remission (CR) or partial remission (PR) as the best response during the period from the beginning of the treatment to the progression of the disease or the completion of therapy (CR+PR)/Analysis of the total number of people. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used to assess the objective tumor response.
- Secondary Outcome Measures
Name Time Method Progression-Free Survival (PFS) From the date of starting pyrotinib to the date of first documentation of disease progression or death from any cause (up to approximately 1 year) PFS is defined as the time from the date of starting maintenance therapy to the date of disease progression or death from any cause, whichever occurs first.
Adverse events From the date of starting pyrotinib to the end of the treatment (up to approximately 1 year) Adverse events during maintenance therapy will be assessed according to the NCI CTCAE v5.0.
Trial Locations
- Locations (1)
Renji Hospital, School of Medicine, Shanghai Jiaotong University
🇨🇳Shanghai, China
Renji Hospital, School of Medicine, Shanghai Jiaotong University🇨🇳Shanghai, China