A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Fulvestrant Plus BPI-16350 or Plus Placebo in Patients With HR+, HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer With Disease Progression Following Endocrine Therapy
1 other identifier
interventional
274
1 country
64
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 breast-cancer
Started May 2022
Shorter than P25 for phase_3 breast-cancer
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 25, 2022
CompletedFirst Submitted
Initial submission to the registry
June 16, 2022
CompletedFirst Posted
Study publicly available on registry
June 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedJuly 27, 2023
May 1, 2023
1.6 years
June 16, 2022
July 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Investigator-assessed PFS
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.
up to 3 years
Secondary Outcomes (9)
IREC-assessed PFS
up to 3 years
ORR
up to 3 years
DCR
up to 3 years
DOR
up to 3 years
CBR
up to 3 years
- +4 more secondary outcomes
Study Arms (2)
experimental group
EXPERIMENTALIntervention Drug: BPI-16350, Fulvestrant
control group
PLACEBO COMPARATORIntervention Drug: Placebo, Fulvestrant
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (64)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233099, China
Anhui Provincial Hospital
Hefei, Anhui, 230002, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
The First Medical Center of the PLA General Hospital
Beijing, Beijing Municipality, 100039, China
The Seventh Medical Center of the PLA General Hospital
Beijing, Beijing Municipality, 100039, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 400030, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
The First Affiliated Hospital of Xiamen University
Ximen, Fujian, 361003, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730013, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
Sun Yat-Sen University Cancer Hospital
Guangzhou, Guangdong, 510060, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515041, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Cangzhou Hospital of Integrated TCM-WM·Hebei
Cangzhou, Hebei, 061012, China
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, 067020, China
Tangshan People's Hospital
Tangshan, Hebei, 063001, China
Xingtai People's Hospital
Xingtai, Hebei, 054001, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
Anyang Cancer Hospital
Anyang, Henan, 455001, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 450052, China
The first Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, 473007, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
The Central Hospital of Wuhan
Wuhan, Hubei, 430014, China
Fifth Hospital in WuHan
Wuhan, Hubei, 430050, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Yichang Central People's Hospital
Yichang, Hubei, 443008, China
The First People's Hospital Of Changde City
Changde, Hunan, 415003, China
Hunan Cancer Hospital
Changsha, Hunan, 410031, China
Chenzhou First People's Hospital
Chenzhou, Hunan, 423099, China
The First Affiliated Hospital of Nanhua University
Hengyang, Hunan, 421001, China
Loudi Central Hospital
Loudi, Hunan, 417099, China
Shaoyang Central Hospital
Shaoyang, Hunan, 422000, China
Yongzhou Central Hospital
Yongzhou, Hunan, 425002, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412007, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009, China
The First Affiliated Hospital of Gannan Medical College
Ganzhou, Jiangxi, 100044, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The Third Hospital of Nanchang
Nanchang, Jiangxi, 330008, China
Jilin Cancer Hospital
Changchun, Jilin, 130012, China
The Second Hospital of Jilin University
Changchun, Jilin, 130041, China
Jilin Hospital of Chinese Literature
Siping, Jilin, 132011, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116023, China
The First Hospital of China Medical University
Shenyang, Liaoning, 100012, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Liaoning Cancer Hospital ＆ Institute
Shenyang, Liaoning, 110801, China
Inner Mongolia People's Hospital
Hohhot, Neimenggu, 421001, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272007, China
Linyi Cancer Hospital
Linyi, Shandong, 276002, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003, China
Weihai Municipal Hospital
Weihai, Shandong, 264299, China
Weifang People's Hospital
Weifang, Shangdong, 261000, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Sichuan Cancer Hospital&Institute
Chengdu, Sichuan, 610042, China
The Sixth People's Hospital of Chengdu
Chengdu, Sichuan, 610051, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300181, China
Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650118, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
Related Publications (2)
Tao Z, Zhang J, Zheng Q, Wang Y, Cai L, Xu H, Xu X, Kong X, Ding S, Hao C, Wang H, Zong H, Jin X, Wang X, Li Y, Yang X, Li W, Du X, Chen H, Wu P, Li P, Mao L, Ding L, Hu X, Wang S. Tibremciclib or Placebo Plus Fulvestrant in Hormone Receptor-Positive and ERBB2-Negative Advanced Breast Cancer After Endocrine Therapy: A Randomized Clinical Trial. JAMA Oncol. 2025 Sep 1;11(9):1055-1063. doi: 10.1001/jamaoncol.2025.2092.
PMID: 40742733DERIVEDZhang J, Liu R, Gao S, Chen W, Han X, Wang Z, Zhou H, Wang Y, Chen J, Ma Y, Liu K, Shen Z, Ding L, Li P, Hu X. A phase I dose-escalation and dose-expansion study of tibremciclib, a novel CDK4/6 inhibitor, monotherapy and in combination with fulvestrant in HR-positive/HER2-negative advanced breast cancer. ESMO Open. 2025 Jun;10(6):105121. doi: 10.1016/j.esmoop.2025.105121. Epub 2025 May 21.
PMID: 40403388DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xichun Hu, Ph.D
Fudan University
- PRINCIPAL INVESTIGATOR
Shuseng Wang
Sun Yat-Sen University Cancer Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2022
First Posted
June 27, 2022
Study Start
May 25, 2022
Primary Completion
December 31, 2023
Study Completion
July 31, 2025
Last Updated
July 27, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share