[Translation] A Phase Ib/II clinical study evaluating the safety and tolerability, efficacy, and pharmacokinetic characteristics of QLC1401 tablets combined with a CDK4/6 inhibitor or an mTOR inhibitor in patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer
Ib期:评估QLC1401片与CDK4/6抑制剂或mTOR抑制剂联合用药在ER+/HER2-局部晚期或转移性乳腺癌患者中的安全性和耐受性,并确定联合治疗的Ⅱ期推荐剂量(RP2D)。
II期:评估QLC1401片与CDK4/6抑制剂或mTOR抑制剂联合用药在ER+/HER2-局部晚期或转移性乳腺癌患者中的有效性。
[Translation] Phase Ib: Evaluate the safety and tolerability of QLC1401 tablets in combination with a CDK4/6 inhibitor or an mTOR inhibitor in patients with ER+/HER2- locally advanced or metastatic breast cancer and determine the recommended Phase II dose (RP2D) for combination therapy.
Phase II: Evaluate the efficacy of QLC1401 tablets in combination with a CDK4/6 inhibitor or an mTOR inhibitor in patients with ER+/HER2- locally advanced or metastatic breast cancer.