Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer

Lead sponsor

Wenjin Yin is the lead sponsor of 8 studies on the registry; 5 are open to participants now.

Study arms

• Experimental
  Intermittent pyrotinib

  Intermittent use of pyrotinib, 14 days on and 7 days of, every 21 days

  Drug: Pyrotinib

• Active comparator
  Continuous pyroitnib

  oral pyrotinib qd

  Drug: Pyrotinib

Interventions

• DrugPyrotinib

  anti-HER2 tyrosine kinase inhibitor

Primary outcomes

1. Overall response rate (ORR)

   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.

   Time frame: From the date of starting pyrotinib to the date of confirmed CR or PR (up to approximately 1 years)

Secondary outcomes

1. Progression-Free Survival (PFS)

   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.

   Time frame: 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)

2. Adverse events

   Adverse events during maintenance therapy will be assessed according to the NCI CTCAE v5.0.

   Time frame: From the date of starting pyrotinib to the end of the treatment (up to approximately 1 year)

Individual participant data

Plan to share: No