To explore the efficacy and safety of Everolimus (SNF1 subtype) or Fluzoparib (SNF3 subtype) combined with Fulvestrant and Abemaciclib vs. Fulvestrant combined with Abemaciclib in patients with HR+/HER2- breast cancer of SNF1/SNF3 subtype who have progressed after CDK 4/6 inhibitor treatment.
This is a randomized, controlled, open-label, phase II study to explore the efficacy and safety of a three-drug combination of Everolimus or Fluzoparib plus Fulvestrant and Abemaciclib compared to a two-drug combination of Fulvestrant plus Abemaciclib in patients with HR+ HER2-advanced breast cancer of SNF1/SNF3 subtype who have progressed after CDK 4/6 inhibitor treatment. The study consists of Safety Lead-in phase, which aims to explore the safety and preliminary efficacy of the three-drug combination, and phase II, which aims to explore the efficacy of the three-drug combination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
270 Dongan Road, Fudan University Shanghai Cancer Center
Shanghai, China
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0( Safety lead-in Phase)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
objective response rate (ORR)( Safety lead-in Phase)
objective response rate (ORR)
Time frame: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
Progression-free survival (PFS)(Phase II)
Progression-free survival (PFS)
Time frame: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
Overall survival (OS)(Phase II)
Overall survival (OS)
Time frame: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
objective response rate (ORR)(Phase II)
objective response rate (ORR)
Time frame: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
clinical benefit rate (CBR)(Phase II)
clinical benefit rate (CBR)
Time frame: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
duration of response (DOR)(Phase II)
duration of response (DOR)
Time frame: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
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Abemaciclib
time to first response (TTR)(Phase II)
time to first response (TTR)
Time frame: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Phase II)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
Clinical benefit rate (CBR)( Safety lead-in Phase)
Clinical benefit rate (CBR)
Time frame: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
Progression-free survival (PFS)( Safety lead-in Phase)
Progression-free survival (PFS)
Time frame: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months