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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: BPI-16350; Drug: Fulvestrant; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 274
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233099
      • The First Affiliated Hospital of Bengbu Medical College
    • Hefei, Anhui, China, 230022
      • The First Affiliated Hospital of Anhui Medical University
    • Hefei, Anhui, China, 230002
      • Anhui Provincial Hospital
  • Beijing
    • Beijing, Beijing, China, 100039
      • The First Medical Center of the PLA General Hospital
    • Beijing, Beijing, China, 100039
      • The Seventh Medical Center of the PLA General Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 400030
      • Chongqing University Three Gorges Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital
    • Fuzhou, Fujian, China, 350014
      • Fujian Cancer Hospital
    • Ximen, Fujian, China, 361003
      • The First Affiliated Hospital of Xiamen University
  • Gansu
    • Lanzhou, Gansu, China, 730013
      • The First Hospital of Lanzhou University
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Hospital
    • Shantou, Guangdong, China, 515041
      • Cancer Hospital of Shantou University Medical College
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • The First Affiliated Hospital of Guangxi Medical University
  • Hebei
    • Cangzhou, Hebei, China, 061012
      • Cangzhou Hospital of Integrated TCM-WM·Hebei
    • Chengde, Hebei, China, 067020
      • Affiliated Hospital of Chengde Medical University
    • Tangshan, Hebei, China, 063001
      • Tangshan People's Hospital
    • Xingtai, Hebei, China, 054001
      • Xingtai People's Hospital
  • Heilongjiang
    • Ha'erbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital
  • Henan
    • Anyang, Henan, China, 455001
      • Anyang Cancer Hospital
    • Luoyang, Henan, China, 450052
      • The First Affiliated Hospital of Henan University of Science And Technology
    • Nanyang, Henan, China, 473007
      • The First Affiliated Hospital of Nanyang Medical College
    • Zhengzhou, Henan, China, 450052
      • the First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University
    • Wuhan, Hubei, China, 430014
      • The Central Hospital of Wuhan
    • Wuhan, Hubei, China, 430050
      • Fifth Hospital in Wuhan
    • Yichang, Hubei, China, 443008
      • Yichang Central People's Hospital
  • Hunan
    • Changde, Hunan, China, 415003
      • The First People's Hospital of Changde City
    • Changsha, Hunan, China, 410031
      • Hunan Cancer Hospital
    • Chenzhou, Hunan, China, 423099
      • Chenzhou First People's Hospital
    • Hengyang, Hunan, China, 421001
      • The First Affiliated Hospital of Nanhua University
    • Loudi, Hunan, China, 417099
      • Loudi Central Hospital
    • Shaoyang, Hunan, China, 422000
      • Shaoyang Central Hospital
    • Yongzhou, Hunan, China, 425002
      • Yongzhou Central Hospital
    • Zhuzhou, Hunan, China, 412007
      • ZhuZhou Central Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Jiangsu Cancer Hospital
    • Suzhou, Jiangsu, China, 215004
      • The Second Affiliated Hospital of Soochow University
    • Xuzhou, Jiangsu, China, 221009
      • Xuzhou Central Hospital
  • Jiangxi
    • Ganzhou, Jiangxi, China, 100044
      • The First Affiliated Hospital of Gannan Medical College
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University
    • Nanchang, Jiangxi, China, 330008
      • The Third Hospital of Nanchang
  • Jilin
    • Changchun, Jilin, China, 130041
      • The Second Hospital of Jilin University
    • Changchun, Jilin, China, 130012
      • Jilin Cancer Hospital
    • Siping, Jilin, China, 132011
      • Jilin Hospital of Chinese Literature
  • Liaoning
    • Dalian, Liaoning, China, 116023
      • The Second Affiliated Hospital of Dalian Medical University
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital of China Medical University
    • Shenyang, Liaoning, China, 100012
      • The First Hospital of China Medical University
    • Shenyang, Liaoning, China, 110801
      • Liaoning Cancer Hospital & Institute
  • Neimenggu
    • Hohhot, Neimenggu, China, 421001
      • Inner Mongolia People's Hospital
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital
    • Jining, Shandong, China, 272007
      • Affiliated Hospital of Jining Medical University
    • Linyi, Shandong, China, 276002
      • LinYi Cancer Hospital
    • Qingdao, Shandong, China, 266003
      • The affiliated hospital of Qingdao university
    • Weihai, Shandong, China, 264299
      • Weihai Municipal Hospital
  • Shangdong
    • Weifang, Shangdong, China, 261000
      • Weifang People's Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Shanghai Cancer Center
  • Sichuan
    • Chengdu, Sichuan, China, 610042
      • Sichuan Cancer Hospital&Institute
    • Chengdu, Sichuan, China, 610051
      • The Sixth People's Hospital of Chengdu
  • Tianjin
    • Tianjin, Tianjin, China, 300181
      • Tianjin Cancer Hospital
  • Xinjiang
    • Urumqi, Xinjiang, China, 830000
      • Cancer Hospital of Xinjiang Medical University
  • Yunnan
    • Kunming, Yunnan, China, 650118
      • Yunnan Cancer Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310014
      • Zhejiang Provincial People's Hospital
    • Hangzhou, Zhejiang, China, 310003
      • The Second Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; Intervention Drug: BPI-16350, Fulvestrant	Drug: BPI-16350; BPI-16350 400 mg, orally once daily; Drug: 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
Placebo Comparator: control group; Intervention Drug: Placebo, Fulvestrant	Drug: 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; Drug: placebo; Placebo 400 mg, orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Betta Pharmaceuticals Co., Ltd.
• Investigators: Principal Investigator: Xichun Hu, Ph.D, Fudan University; Principal Investigator: Shuseng Wang, Sun Yat-sen University Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Estrogen Antagonists; Estrogen Receptor Antagonists; Fulvestrant
• Other Study ID Numbers: BTP-66732

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No