Breast Cancer
Conditions
Brief summary
This is a phase III clinical trial to evaluate the efficacy and safety of BPI-16350 in combination with Fulvestrant versus placebo combined with Fulvesrant in Patients who have HR positive and HER2 negative locally advanced，recurrent or metastatic breast cancer with disease progression following endocrine therapy.
Interventions
DRUGBPI-16350
BPI-16350 400 mg, orally once daily
DRUGplacebo
Placebo 400 mg, orally once daily
DRUGFulvestrant
Fulvestrant 500 mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle until progressive disease
Sponsors
Betta Pharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator-assessed PFS | up to 3 years | The PFS time is measured from the date of randomization to the date of objective progression or the date of death due to any cause, whichever is earlier. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | up to 3 years | The proportion of patients with CR or PR according to RECIST v1.1 |
| DCR | up to 3 years | The proportion of patients with CR, PR, or SD according to RECIST v1.1 |
| DOR | up to 3 years | The time from the date of first evidence of a CR or PR to the date of objective progression or death from any cause, whichever is earlier |
| CBR | up to 3 years | The proportion of patients with CR, PR, or SD ≥6 months according to RECIST v1.1 |
| IREC-assessed PFS | up to 3 years | The PFS time is measured from the date of randomization to the date of objective progression or the date of death due to any cause, whichever is earlier. |
| AEs and SAEs | up to 3 years | 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 v5.0 |
| EORTC QLQ-C30 | up to 5 years | Changes in scores from baseline using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) |
| Evaluate the pharmacokinetics of BPI-16350 | Up to 3 cycles(each cycle is 28 days) | Based on blood plasma concentration. |
| OS | up to 5 years | The time from the date of randomization to the date of death from any cause |
Countries
China
Outcome results
None listed