Research topic Preoperative efficacy and safety of pyrrolitinib combined with trastuzumab and AI in the treatment of HR+/HER2+breast cancer Overall: A single arm multicenter phase II exploratory study。Subjects HR+/HER2+breast cancer patients in stage Ⅱ\~Ⅲ A。
Research topic Preoperative efficacy and safety of pyrrolitinib combined with trastuzumab and AI in the treatment of HR+/HER2+breast cancer Overall: A single arm multicenter phase II exploratory study。Subjects HR+/HER2+breast cancer patients in stage Ⅱ\~Ⅲ A。Main research purposes: To explore the efficacy and safety of the combination of large and small molecules (pyrrolidine combined with trastuzumab combined with AI) in the preoperative treatment of early HR+/HER2+breast cancer.Secondary study objective: To explore the feasibility of neoadjuvant descending ladder therapy and the changes in ctDNA to provide clues for screening predictive markers.Primary endpoint: Pathological complete response rate (tpCR: ypT0-is/ypN0)。Secondary end points: optimal overall response rate (BORR), bpCR (ypT0-is), tumor residual load (RCB), disease free survival (DFS), breast retention rate, safety。Pyrrolidine (400mg po qd),Trastuzumab (initial dose 8 mg/kg, follow-up 6 mg/kg ivgtt, d1, Q 3w, total 6 Period),Anatriazole (1mg po qd)/ Letrozole (2.5mg po qd).For premenopausal or perimenopausal patients, it is necessary to combine OFS (OFS includes bilateral eggs Nest removal or GnRHa drugs).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Subjects who met the inclusion criteria underwent surgery after 6 cycles of treatment with pirotinib+trastuzumab+AI, and their postoperative pathological remission was evaluated.
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGFollow up on postoperative pathological reports for evaluation for Pathological complete response rate (tpCR: ypT0-is/ypN0)
Follow up on postoperative pathological reports for evaluation rely onMiller\&Payne principles
Time frame: 18weeks
Follow up on postoperative pathological reports for evaluation for Optimal overall response rate (BORR)
Follow up on postoperative pathological reports for evaluation rely onMiller\&Payne principles
Time frame: 18weeks
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