The goal of this clinical trial is to learn if SHR-A1811 combine with Pyrotinib is safe and tolerable for patients with HER2 positive breast cancer. It will also learn about the anti-tumor efficacy of this combination therapy. Participants will take SHR-A1811 and pyrotinib every three weeks, until disease progression or intolerable toxicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
SHR-A1811 4.0mg/kg, IV, Day 1, Q3W
Pyrotinib 240mg, po, QD, from Day 8 to Day 21,Q3W
SHR-A1811 4.8mg/kg, IV, D1, Q3W
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
the proportion of patients who experienced treatment-emergent adverse events during the study treatment among the total number of patients experienced study treatment.
Time frame: From the date of signing ICF until the end of the safety follow-up period, defined as 40 days after the last administration of SHR-A1811 or Pyrotinib
ORR
Objective Response Rate: The proportion of subjects achieving a best overall response(per RECIST v1.1) of complete response (CR) or partial response (PR) during the period from initiation of the study treatment until disease progression (or treatment discontinuation), relative to the total number of subjects in the analysis set.
Time frame: from initiation of the study treatment until disease progression (or treatment discontinuation), the observation period is up to 36 months.
PFS
progression free survival: the time interval from the date of ICF assigned until the first documented radiological disease progression (PD) or death from any cause. For subjects who had not experienced PD or death by the data cutoff date, or had received subsequent anti-cancer therapy, censoring will occur at the date of the last valid tumor assessment prior to the data cutoff date, or the initiation date of new anti-cancer therapy, whichever occurs first .
Time frame: from the date of enrollment until the first documented radiological disease progression (PD) or death from any cause, the observation period is up to 36 months.
OS
over all survival: The time from the date of enrollment to the date of death due to any cause. For subjects alive at the last follow-up , OS will be censored at the date of last contact . For subjects lost to follow-up , OS will be censored at the last date the subject was verified alive .Censored OS is defined as the time from enrollment to the censoring date.
Time frame: The time from the date of enrollment to the date of death due to any cause. The observation period is up to 60 months.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pyrotinib 320mg, po, QD, from Day 8 to Day 21, Q3W
DoR
Duration of response:The time interval from the date of first documented response (complete response \[CR\] or partial response \[PR\], whichever is recorded earlier) until the date of disease progression or death of any cause.
Time frame: from the date of first documented response to the date of disease progression or death of any cause, the observation period is up to 36 months.