A Trial of SHR-A1811versus Pyrotinib in Combination With Capecitabine in HER2-Positive, Unresecta… (NCT05424835) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Trial of SHR-A1811versus Pyrotinib in Combination With Capecitabine in HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane
China381 participantsStarted 2022-08-04
Plain-language summary
The study is being conducted to evaluate whether the efficacy of SHR-A1811 is better than Pyrotinib in combination with Capecitabine in HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. Able and willing to provide a written informed consent;
✓. Unresectable or metastatic HER2 positive breast cancer previously treated with Trastuzumab and Taxane in recurrence and metastasis stage;
✓. Documented disease progression;
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
✓. Life expectancy ≥ 12 weeks.
✓. Subject has measurable disease based on RECIST v1.1;
✓. Important organ function can meet the criteria (no blood component and cell growth factor treatment within 14 days before the first study drug administration)
✓. Pregnancy and Contraception:
Exclusion criteria
✕. Subjects with other malignant tumors in the past 5 years (except for the cured skin basal cell carcinoma and cervical carcinoma in situ).
✕. There is a third interstitial effusion (e.g., massive ascites, pleural effusion, pericardial effusion) that cannot be controlled by drainage or other methods.
✕. Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect drug administration and absorption.
✕. Received mitomycin C and nitrosoureas chemotherapy within 6 weeks before the first study drug administration.
What they're measuring
1
PFS（BIRC assessment）between SHR-A1811 4.8mg/kg Q3W and Pyrotinib in combination with Capecitabine.
Timeframe: 6 weeks after the first study drug administration，about 2 years.
✕. Any surgery (eg., major surgery for cancer), radiotherapy, chemotherapy, immunotherapy or molecular targeted therapy, biotherapy or other drug clinical trial within 4 weeks; received endocrine therapy within 2 weeks before the first study drug administration.
✕. Any concurrent use of immunosuppressant or systemic corticosteroid treatment to achieve immunosuppression purpose (dose of \> 10mg/day prednisone or equivalent), and still in use within 2 weeks before the first study drug administration.
✕. History of autoimmune disease with the possibility of recurrence or active autoimmune disease; subjects with skin diseases without systematic treatment such as vitiligo, psoriasis, alopecia, or controlled type I diabetes treated with insulin can be included; asthma completely relieved in childhood without any intervention in adult can be included, subjects that requires medical intervention with bronchodilators for asthma cannot be included).
✕. History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV) or other acquired or congenital immune-deficient disease, or organ transplantation.