A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT05433480
- Lead Sponsor
- Betta Pharmaceuticals Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 274
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description experimental group Fulvestrant Intervention Drug: BPI-16350, Fulvestrant experimental group BPI-16350 Intervention Drug: BPI-16350, Fulvestrant control group placebo Intervention Drug: Placebo, Fulvestrant control group Fulvestrant Intervention Drug: Placebo, Fulvestrant
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method DCR up to 3 years The proportion of patients with CR, PR, or SD according to RECIST v1.1
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
ORR up to 3 years The proportion of patients with CR or PR according to RECIST v1.1
OS up to 5 years The time from the date of randomization to the date of death from any cause
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)
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.
Evaluate the pharmacokinetics of BPI-16350 Up to 3 cycles(each cycle is 28 days) Based on blood plasma concentration.
Trial Locations
- Locations (64)
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
The First Medical Center of the PLA General Hospital
🇨🇳Beijing, Beijing, China
The Seventh Medical Center of the PLA General Hospital
🇨🇳Beijing, Beijing, China
Chongqing University Three Gorges Hospital
🇨🇳Chongqing, Chongqing, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
🇨🇳Ximen, Fujian, China
The First Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Scroll for more (54 remaining)The First Affiliated Hospital of Bengbu Medical College🇨🇳Bengbu, Anhui, China