Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Study arms

• Active comparator
  continuous pyrotinib

  pyrotinib 400 mg, orally once daily for one year

  Drug: pyrotinib

• Experimental
  intermittent pyrotinib

  pyrotinib 400 mg, 14 days on and 7 days off, every 21 days for 17 cycles

  Drug: pyrotinib

Interventions

• Drugpyrotinib

  an irreversible anti-HER2 tyrosine kinase inhibitor

Primary outcomes

1. Invasive Disease-free Survival (iDFS)

   Invasive disease-free survival time is defined as the time from date of randomization until the first invasive disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.

   Time frame: From randomization until time of event up to 2 years.

Secondary outcomes

1. Disease-free Survival (DFS)

   Disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, non-breast primary invasive cancer, ductal carcinoma in situ (DCIS),or distant recurrence and death from any cause

   Time frame: From randomization until time of event up to 2 years

2. Overall Survival (OS)

   Overall survival is defined as the time from randomization to death from any cause.

   Time frame: From randomization until time of event up to 2 years

3. Adverse events

   Adverse events 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