Pyrotinib Plus Vinorelbine in Participants With HER2-positive Previously Treated Locally Advanced or Metastatic Breast Cancer

Sponsor
Sun Yat-sen University
Study ID
NCT04605575
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Pyrotinib 320mg + Vinorelbine — DRUG
    pyrotinib 320mg tablets administered daily by mouth, vinorelbine(po) 80 mg/m2 weekly (following a first cycle at 60 mg/m2) administered on day 1 and day 8 of 21 day cycle. Treatment lasts for two cycles
  • Pyrotinib 400mg + Vinorelbine — DRUG
    pyrotinib 400mg tablets administered daily by mouth, vinorelbine(po) 80 mg/m2 weekly (following a first cycle at 60 mg/m2) administered on day 1 and day 8 of 21 day cycle. Treatment lasts for two cycles
  • Pyrotinib plus Vinorelbine — DRUG
    pyrotinib administered daily by mouth（MTD）, vinorelbine(po) 80 mg/m2 weekly (following a first cycle at 60 mg/m2) administered on day 1 and day 8 of 21 day cycle, or vinorelbine(iv) 25 mg/m2 on day 1 and day 8 of 21 day cycle. Treatments will lasts until disease progression (as assessed by the investigator) or unmanageable toxicity.

Study Details

The purpose of this study is to identify the highest tolerable dose of pyrotinib in combination with vinorelbine and to assess the safety and efficacy of the combination in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer. The study will be conducted in two parts. In the first part, testing will be done on up to 12 subjects to determine the highest tolerable dose of pyrotinib and vinorelbine in patients with advanced solid tumors. In the second part of the study, we will explore the safety and efficacy of Pyrotinib + vinorelbine in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination.

Key Dates

Start date
May 22, 2020
Status verified
Apr 2022
Primary completion
Aug 1, 2023
Completion
Dec 1, 2023

Study Design

Enrollment
208 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pyrotinib plus vinorelbine

Primary Outcome Measure

PFS as Assessed by the Investigator [ Time Frame: from enrollment to progression or death (for any reason), assessed up to 3 years ]

Central Contacts

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