Back to resultsA Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer
Primary Purpose
Breast Cancer
Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
BPI-16350
placebo
Fulvestrant
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
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
Sites / Locations
- The First Affiliated Hospital of Bengbu Medical College
- Anhui Provincial Hospital
- The First Affiliated Hospital of Anhui Medical University
- The First Medical Center of the PLA General Hospital
- The Seventh Medical Center of the PLA General Hospital
- Chongqing University Three Gorges Hospital
- Fujian Medical University Union Hospital
- Fujian Cancer Hospital
- The First Affiliated Hospital of Xiamen University
- The First Hospital of Lanzhou University
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Sun Yat-Sen University Cancer Hospital
- Cancer Hospital of Shantou University Medical College
- The First Affiliated Hospital of Guangxi Medical University
- Cangzhou Hospital of Integrated TCM-WM·Hebei
- Affiliated Hospital of Chengde Medical University
- Tangshan People's Hospital
- Xingtai People's Hospital
- Harbin Medical University Cancer Hospital
- Anyang Cancer Hospital
- The First Affiliated Hospital of Henan University of Science and Technology
- The first Affiliated Hospital of Nanyang Medical College
- The First Affiliated Hospital of Zhengzhou University
- The Central Hospital of Wuhan
- Fifth Hospital in WuHan
- Renmin Hospital of Wuhan University
- Hubei Cancer Hospital
- Yichang Central People's Hospital
- The First People's Hospital Of Changde City
- Hunan Cancer Hospital
- Chenzhou First People's Hospital
- The First Affiliated Hospital of Nanhua University
- Loudi Central Hospital
- Shaoyang Central Hospital
- Yongzhou Central Hospital
- Zhuzhou Central Hospital
- Jiangsu Cancer Hospital
- The Second Affiliated Hospital of Soochow University
- Xuzhou Central Hospital
- The First Affiliated Hospital of Gannan Medical College
- The First Affiliated Hospital of Nanchang University
- The Third Hospital of Nanchang
- Jilin Cancer Hospital
- The Second Hospital of Jilin University
- Jilin Hospital of Chinese Literature
- The Second Affiliated Hospital of Dalian Medical University
- The First Hospital of China Medical University
- Shengjing Hospital of China Medical University
- Liaoning Cancer Hospital ＆ Institute
- Inner Mongolia People's Hospital
- Shandong Cancer Hospital
- Affiliated Hospital of Jining Medical University
- Linyi Cancer Hospital
- The Affiliated Hospital of Qingdao University
- Weihai Municipal Hospital
- Weifang People's Hospital
- Fudan University Shanghai Cancer Center
- Sichuan Cancer Hospital&Institute
- The Sixth People's Hospital of Chengdu
- Tianjin Cancer Hospital
- Cancer Hospital of Xinjiang Medical University
- Yunnan Cancer Hospital
- The Second Affiliated Hospital of Zhejiang University School of Medicine
- Zhejiang Provincial People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
experimental group
control group
Arm Description
Intervention Drug: BPI-16350, Fulvestrant
Intervention Drug: Placebo, Fulvestrant
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
IREC-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.
ORR
The proportion of patients with CR or PR according to RECIST v1.1
DCR
The proportion of patients with CR, PR, or SD according to RECIST v1.1
DOR
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
The proportion of patients with CR, PR, or SD ≥6 months according to RECIST v1.1
OS
The time from the date of randomization to the date of death from any cause
AEs and SAEs
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
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
Based on blood plasma concentration.
Full Information
NCT ID
NCT05433480
First Posted
June 16, 2022
Last Updated
July 25, 2023
Sponsor
Betta Pharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05433480
Brief Title
A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Betta Pharmaceuticals Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
274 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
Intervention Drug: BPI-16350, Fulvestrant
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Intervention Drug: Placebo, Fulvestrant
Intervention Type
Drug
Intervention Name(s)
BPI-16350
Intervention Description
BPI-16350 400 mg, orally once daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo 400 mg, orally once daily
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Intervention Description
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
Primary Outcome Measure Information:
Title
Investigator-assessed PFS
Description
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.
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
IREC-assessed PFS
Description
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.
Time Frame
up to 3 years
Title
ORR
Description
The proportion of patients with CR or PR according to RECIST v1.1
Time Frame
up to 3 years
Title
DCR
Description
The proportion of patients with CR, PR, or SD according to RECIST v1.1
Time Frame
up to 3 years
Title
DOR
Description
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
Time Frame
up to 3 years
Title
CBR
Description
The proportion of patients with CR, PR, or SD ≥6 months according to RECIST v1.1
Time Frame
up to 3 years
Title
OS
Description
The time from the date of randomization to the date of death from any cause
Time Frame
up to 5 years
Title
AEs and SAEs
Description
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
Time Frame
up to 3 years
Title
EORTC QLQ-C30
Description
Changes in scores from baseline using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Time Frame
up to 5 years
Title
Evaluate the pharmacokinetics of BPI-16350
Description
Based on blood plasma concentration.
Time Frame
Up to 3 cycles(each cycle is 28 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xichun Hu, Ph.D
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shuseng Wang
Organizational Affiliation
Sun Yat-Sen University Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233099
Country
China
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230002
Country
China
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
The First Medical Center of the PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
The Seventh Medical Center of the PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
Chongqing University Three Gorges Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Ximen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Facility Name
The First Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730013
Country
China
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Sun Yat-Sen University Cancer Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Cancer Hospital of Shantou University Medical College
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515041
Country
China
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Cangzhou Hospital of Integrated TCM-WM·Hebei
City
Cangzhou
State/Province
Hebei
ZIP/Postal Code
061012
Country
China
Facility Name
Affiliated Hospital of Chengde Medical University
City
Chengde
State/Province
Hebei
ZIP/Postal Code
067020
Country
China
Facility Name
Tangshan People's Hospital
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
063001
Country
China
Facility Name
Xingtai People's Hospital
City
Xingtai
State/Province
Hebei
ZIP/Postal Code
054001
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Ha'erbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Anyang Cancer Hospital
City
Anyang
State/Province
Henan
ZIP/Postal Code
455001
Country
China
Facility Name
The First Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
The first Affiliated Hospital of Nanyang Medical College
City
Nanyang
State/Province
Henan
ZIP/Postal Code
473007
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
The Central Hospital of Wuhan
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430014
Country
China
Facility Name
Fifth Hospital in WuHan
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430050
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Yichang Central People's Hospital
City
Yichang
State/Province
Hubei
ZIP/Postal Code
443008
Country
China
Facility Name
The First People's Hospital Of Changde City
City
Changde
State/Province
Hunan
ZIP/Postal Code
415003
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410031
Country
China
Facility Name
Chenzhou First People's Hospital
City
Chenzhou
State/Province
Hunan
ZIP/Postal Code
423099
Country
China
Facility Name
The First Affiliated Hospital of Nanhua University
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
421001
Country
China
Facility Name
Loudi Central Hospital
City
Loudi
State/Province
Hunan
ZIP/Postal Code
417099
Country
China
Facility Name
Shaoyang Central Hospital
City
Shaoyang
State/Province
Hunan
ZIP/Postal Code
422000
Country
China
Facility Name
Yongzhou Central Hospital
City
Yongzhou
State/Province
Hunan
ZIP/Postal Code
425002
Country
China
Facility Name
Zhuzhou Central Hospital
City
Zhuzhou
State/Province
Hunan
ZIP/Postal Code
412007
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Facility Name
Xuzhou Central Hospital
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221009
Country
China
Facility Name
The First Affiliated Hospital of Gannan Medical College
City
Ganzhou
State/Province
Jiangxi
ZIP/Postal Code
100044
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
The Third Hospital of Nanchang
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330008
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
The Second Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Facility Name
Jilin Hospital of Chinese Literature
City
Siping
State/Province
Jilin
ZIP/Postal Code
132011
Country
China
Facility Name
The Second Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116023
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
100012
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
Liaoning Cancer Hospital ＆ Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110801
Country
China
Facility Name
Inner Mongolia People's Hospital
City
Hohhot
State/Province
Neimenggu
ZIP/Postal Code
421001
Country
China
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Name
Affiliated Hospital of Jining Medical University
City
Jining
State/Province
Shandong
ZIP/Postal Code
272007
Country
China
Facility Name
Linyi Cancer Hospital
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276002
Country
China
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266003
Country
China
Facility Name
Weihai Municipal Hospital
City
Weihai
State/Province
Shandong
ZIP/Postal Code
264299
Country
China
Facility Name
Weifang People's Hospital
City
Weifang
State/Province
Shangdong
ZIP/Postal Code
261000
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Sichuan Cancer Hospital&Institute
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610042
Country
China
Facility Name
The Sixth People's Hospital of Chengdu
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610051
Country
China
Facility Name
Tianjin Cancer Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300181
Country
China
Facility Name
Cancer Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Facility Name
Yunnan Cancer Hospital
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650118
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer
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