Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Betta Pharmaceuticals Co., Ltd.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Has the pathologically-confirmed diagnosis of locally advanced, recurrent or metastatic, HR positive, HER2 negative Breast Cancer
One previous line of chemotherapy for advanced/metastatic disease is allowed
Disease Progression following endocrine therapy
Have postmenopausal status
Have 1 of the following, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: measurable disease or nonmeasurable bone-only disease
ECOG: 0\~1
Adequate organ function
You may not be if
Previous treatment with cytotoxic drugs within 4 weeks before enrollment
Previous treatment with endocrine or small molecule drug tyrosine kinase inhibitor TKI within 2 weeks before enrollment
Patients who received prior treatment with any CDK4/6 inhibitor, everolimus or fulvestant
HER2 positive
Patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, ILD, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, conditions affecting drug swallow and absorption, etc
Pregnancy or lactation
Other conditions considered not appropriate to participate in this trial by the investigators
Clareo Health | A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer