This is a phase IB/II clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Letrozole or Anastrozole or Fulvestrant. Patients who have HR positive and HER2 negative recurrent/metastatic breast cancer and have not received systemic anticancer therapy are eligible for study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
SHR6390 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
Letrozole 2.5mg or anastrozole 1mg, orally once daily (continuously), or Fulvestrant 500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle until progressive disease
Ha'erbin Tumor Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Sir Run Run Shaw Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Number of Participants With adverse events (AEs) and serious adverse events (SAEs) at Phase 1
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03. Up to 24 months.
Time frame: Up to 4 weeks
Area under the plasma concentration versus time curve (AUC) of SHR6390
Time frame: Up to 4 weeks
Peak Plasma Concentration (Cmax) of SHR6390
Time frame: Up to 4 weeks
The time of SHR6390 to reach the maximum concentration (Tmax)
Time frame: Up to 4 weeks
Half-time (t1/2) of SHR6390
Time frame: Up to 4 weeks
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ¡Ý30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Time frame: Up to approximately 24 months.
Progression-free Survival (PFS) per RECIST 1.1
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first.
Time frame: Up to approximately 24 months.
Disease Control Rate (DCR) per RECIST 1.1
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.
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Time frame: Up to approximately 24 months.
Number of Participants With adverse events (AEs) and serious adverse events (SAEs)
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.
Time frame: Up to approximately 24 months.