Phase II Clinical Study of Darsilide Combined With Exemestane+Goserelin Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients
A multicenter, prospective, open, randomized cohort, non controlled phase II clinical study to evaluate the effectiveness and safety of Darxil combined with Exemestane+goserelin neoadjuvant endocrine therapy in HR positive and HER2 negative premenopausal breast cancer patients. The study object was to evaluate the HR positive and HER2 negative premenopausal breast cancer patients with SD after 2 cycles of neoadjuvant chemotherapy. The main endpoint was the objective response rate (ORR) of treatment
• All patients were operable estrogen receptor (ER) positive (\>1%), regardless of PR expression level, HER2 receptor negative invasive breast cancer. Follow the 2018 ASCO-CAP HER2 negative interpretation guideline standard. Confirmed by the pathological laboratory that the immunohistochemical (IHC) score is 0 or 1-2+and the in situ hybridization (ISH) test is negative (ISH amplification rate\<2.0);
• Stage II-III initial treatment patients whose tumor staging meets the AJCC 8th edition standards;
• At least one measurable breast and/or axillary disease;
• ECOG 0-1, with an estimated lifespan of at least 12 months;
• The functional level of the main organs must meet the following requirements:
⁃ Blood routine: ANC ≥ 1.5 × ten9/L; PLT ≥ 90 × ten9/L; Hb ≥ 90 g/L;Blood biochemistry: TBIL ≤ 2.5 × ULN; ALT and AST ≤ 2.5 × ULN; BUN and Cr≤ 1.5 × ULN;
• Lead ECG: QT interval (QTcF) corrected by Fridericia method\<470 ms for women;
• Able to accept all puncture biopsies required by the protocol;
• Volunteer to join this study, sign informed consent, have good compliance, and be willing to cooperate with follow-up;
• Women with fertility potential must have a negative Pregnancy test (urine or serum) within 7 days after administration,
⁃ And agree to use acceptable birth control methods during the study period to avoid pregnancy.