A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05433480
• Other study ID #: BTP-66732
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 25, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: May 2023
• Source: Betta Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 274
• Est. completion date: July 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• BPI-16350
BPI-16350 400 mg, orally once daily
• placebo
Placebo 400 mg, orally once daily
• Fulvestrant
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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	up to 3 years
Secondary	ORR	The proportion of patients with CR or PR according to RECIST v1.1	up to 3 years
Secondary	DCR	The proportion of patients with CR, PR, or SD according to RECIST v1.1	up to 3 years
Secondary	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	up to 3 years
Secondary	CBR	The proportion of patients with CR, PR, or SD =6 months according to RECIST v1.1	up to 3 years
Secondary	OS	The time from the date of randomization to the date of death from any cause	up to 5 years
Secondary	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	up to 3 years
Secondary	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)	up to 5 years
Secondary	Evaluate the pharmacokinetics of BPI-16350	Based on blood plasma concentration.	Up to 3 cycles(each cycle is 28 days)