This is a Study to Evaluate the Efficacy and Safety of Multiple Combination Therapies with FWD1802 in Subjects with ER-positive/HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
196
orally QD with 28 days each cycle, treatment till disease progression or intolerable toxicity or withdraw for other reasons
Dose: 125 mg Route: Orally Frequency: Once daily (QD) Schedule: Administered for 21 consecutive days, followed by a 7-day treatment break (3-weeks-on/1-week-off), constituting a 28-day cycle
Dose: 600 mg Route: Orally Frequency: Once daily (QD) Schedule: Administered for 21 consecutive days, followed by a 7-day treatment break, constituting a 28-day cycle
Dose: 150 mg Route: Orally Frequency: BID Schedule: Everyday
Dose: 10 mg Route: Orally Frequency: QD Schedule: Everyday
Fudan University Shanghai Cancer Center, Shanghai
Shanghai, China
RECRUITINGPhase Ib- Dose-Limiting Toxicity (DLT).
Time frame: Approximately 1.5 years
Phase Ib- Maximum Tolerated Dose (MTD).
Time frame: Approximately 1.5 years
Phase Ib- Recommended Phase II Dose (RP2D).
Time frame: Approximately 1.5 years
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number and proportion of participants experiencing any treatment-emergent adverse event during the study period. Assessment criteria: Events will be categorized as "related" or "unrelated" to study drug based on investigator's causality assessment. Reporting format: Frequency counts and percentages stratified by severity grade (Grade 1-5 as per NCI-CTCAE v5.0).
Time frame: Approximately 2 years
Severity Grading of Adverse Events
Maximum severity grade of treatment-emergent adverse events experienced by participants. Assessment tool: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Reporting format: Proportion of participants with events in each severity category (Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening; Grade 5=death).
Time frame: Approximately 2 years
Clinically Significant Abnormalities in 12-Lead ECG Parameters
Number of participants with clinically significant changes in electrocardiogram parameters from baseline. Assessed parameters: QTc interval, PR interval, QRS duration, heart rate.
Time frame: Approximately 2 years
Vital Sign Abnormalities
Proportion of participants with clinically significant deviations in vital signs: Parameters: Systolic/diastolic blood pressure (mmHg), heart rate (bpm), respiratory rate (breaths/min), body temperature (°C).
Time frame: Approximately 2 years
Serious Adverse Events (SAEs) Incidence
Time frame: Approximately 2 years
Phase II- Investigator-assessed Objective Response Rate (ORR) based on RECIST v1.1.
Time frame: Approximately 2 years
Phase Ib- PK Assessment-Tmax
Time to Cmax (Tmax).
Time frame: Approximately 1.5 years
Phase Ib- PK Assessment-Cmax
Maximum plasma concentration (Cmax)
Time frame: Approximately 1.5 years
Phase Ib- PK Assessment-AUC0-t
Area under the concentration versus time curve from time 0 to the last measurable concentration (AUC0-t)
Time frame: Approximately 1.5 years
Phase Ib- PK Assessment-AUC0-inf
The area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
Time frame: Approximately 1.5 years
Phase Ib- PK Assessment-t1/2
elimination half-life time (t1/2)
Time frame: Approximately 1.5 years
Efficacy Assessment-ORR
Tumor response assessments by the corresponding criteria by RECIST v1.1 to assess Objective response rate (ORR)
Time frame: Approximately 2 years
Efficacy Assessment-CBR
Clinical benefit rate (CBR)
Time frame: Approximately 2 years
Efficacy Assessment-DOR
Duration of response (DoR)
Time frame: Approximately 2 years
Efficacy Assessment-DCR
Disease control rate (DCR)
Time frame: Approximately 1.5 years
Efficacy Assessment-PFS
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Progression-free survival (PFS) by IRC according to RECIST 1.1.PFS is defined as time from the first dose until disease progression or death from any cause, whichever occurs first.
Time frame: Approximately 2 years
Efficacy Assessment-OS
Overall survival (OS).OS is defined as time from date of the first dose to date of death due to any cause.
Time frame: Approximately 2 years
Pharmacokinetic (PK) Parameters:Plasma Concentration at Each Sampling Time Point.
Time frame: Approximately 2 years