This is a randomized, parallel-controlled, open-label, multicenter clinical study to assess the efficacy and safety of D-0502 in the treatment of subjects with ER-positive, HER2-negative locally advanced or metastatic breast cancer with fulvestrant injection as a control drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
640
* Dosage form: Tablet * Administration route: Oral, once a day
* Dosage form: Injection * Administration route: Intramuscular injection, once a month, and another dose administered two weeks after the first dose
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RECRUITINGProgression free survival (PFS) assessed by Independent Review Committee (IRC)
Time frame: From enrollment to the end of treatment, up to 2 years
Progression free survival (PFS) -assessed by investigators
Time frame: From enrollment to the end of treatment, up to 2 years
Objective response rate (ORR) -assessed by IRC and investigators
Time frame: From enrollment to the end of treatment, up to 2 years
Clinical benefit rate (CBR) -assessed by IRC and investigators
Time frame: From enrollment to the end of treatment, up to 2 years
Disease control rate (DCR)-assessed by IRC and investigators
Time frame: From enrollment to the end of treatment, up to 2 years
Clearance (Cl) of D-0502
Time frame: on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1 (each cycle is 28 days)
Overall Survival (OS)
Time frame: From end of treatment to end of study, about 2 years
Number of participants with adverse events/serious adverse events and abnormal laboratory test results
Time frame: From enrollment to 30 days after last dose
Volume of distribution (Vd) of D-0502
Time frame: on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1 (each cycle is 28 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.