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 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
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
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)
Affiliated Hospital of Chengde Medical University
🇨🇳Chengde, Hebei, China
Sun Yat-Sen University Cancer Hospital
🇨🇳Guangzhou, Guangdong, China
Inner Mongolia People's Hospital
🇨🇳Hohhot, Neimenggu, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
The First Medical Center of the PLA General Hospital
🇨🇳Beijing, Beijing, China
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
The Seventh Medical Center of the PLA General Hospital
🇨🇳Beijing, Beijing, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Chongqing University Three Gorges Hospital
🇨🇳Chongqing, Chongqing, China
The First Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
The First Affiliated Hospital of Xiamen University
🇨🇳Ximen, Fujian, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Cancer Hospital of Shantou University Medical College
🇨🇳Shantou, Guangdong, China
Cangzhou Hospital of Integrated TCM-WM·Hebei
🇨🇳Cangzhou, Hebei, China
Xingtai People's Hospital
🇨🇳Xingtai, Hebei, China
Tangshan People's Hospital
🇨🇳Tangshan, Hebei, China
Harbin Medical University Cancer Hospital
🇨🇳Ha'erbin, Heilongjiang, China
Anyang Cancer Hospital
🇨🇳Anyang, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China
The first Affiliated Hospital of Nanyang Medical College
🇨🇳Nanyang, Henan, China
The Central Hospital of Wuhan
🇨🇳Wuhan, Hubei, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Fifth Hospital in WuHan
🇨🇳Wuhan, Hubei, China
Chenzhou First People's Hospital
🇨🇳Chenzhou, Hunan, China
Yichang Central People's Hospital
🇨🇳Yichang, Hubei, China
The First People's Hospital Of Changde City
🇨🇳Changde, Hunan, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of Nanhua University
🇨🇳Hengyang, Hunan, China
Loudi Central Hospital
🇨🇳Loudi, Hunan, China
Shaoyang Central Hospital
🇨🇳Shaoyang, Hunan, China
Yongzhou Central Hospital
🇨🇳Yongzhou, Hunan, China
Zhuzhou Central Hospital
🇨🇳Zhuzhou, Hunan, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The First Affiliated Hospital of Gannan Medical College
🇨🇳Ganzhou, Jiangxi, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
The Third Hospital of Nanchang
🇨🇳Nanchang, Jiangxi, China
The Second Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Xuzhou Central Hospital
🇨🇳Xuzhou, Jiangsu, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Jilin Hospital of Chinese Literature
🇨🇳Siping, Jilin, China
The Second Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Liaoning Cancer Hospital ＆ Institute
🇨🇳Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
Linyi Cancer Hospital
🇨🇳Linyi, Shandong, China
Affiliated Hospital of Jining Medical University
🇨🇳Jining, Shandong, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
Sichuan Cancer Hospital&Institute
🇨🇳Chengdu, Sichuan, China
Weihai Municipal Hospital
🇨🇳Weihai, Shandong, China
Weifang People's Hospital
🇨🇳Weifang, Shangdong, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Tianjin Cancer Hospital
🇨🇳Tianjin, Tianjin, China
The Sixth People's Hospital of Chengdu
🇨🇳Chengdu, Sichuan, China
Cancer Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
Yunnan Cancer Hospital
🇨🇳Kunming, Yunnan, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China