A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of GB491 in Combination With Letrozole in Subjects With HR Positive and HER2 Negative Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received Systemic Therapy in This Disease Setting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05851014
• Other study ID #: GB491-008
• Status: Recruiting
• Phase: Phase 3
• Start date: January 14, 2022
• Est. completion date: January 30, 2027

Study information

• Verified date: May 2023
• Source: Genor Biopharma Co., Ltd.
• Contact: Yankun Fu, Master
• Phone: 021-60751991
• Email: yankun.fu[@]genorbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate the efficacy and safety of GB491 combined with Letrozole versus placebo combined with Letrozole in the treatment of HR+/HER2- locally advanced or metastatic breast cancer without prior systemic antitumor therapy

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: January 30, 2027
• Est. primary completion date: January 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 1. Age: 18-75 years old;

• Have a pathologically-confirmed diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer;

• No previous systematic antitumor therapy for locally advanced or metastatic breast cancer;

• Eastern Cooperative Oncology Group [ECOG] 0-1;

• Have adequate organ and marrow function;

• Agree to sign the informed consent;

Exclusion Criteria:

• Systematic treatment with any other CDK4/6 inhibitor;

• Subjects with known allergy to GB491 or any component of Letrozole;

• Confirmed diagnosis of HER2 positive disease;

• Known uncontrolled, or symptomatic central nervous system metastases;

• Had major surgery (or is expected to require major surgery during the study period), chemotherapy, radiation, any investigational drug, or other antitumor therapy within 4 weeks prior to randomization;

• Have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer;

• Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure, or ventricular arrhythmia which need medical intervention;

• Known history of HIV infection or HIV seropositivity (including HIV antibody positive at the time of screening)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• GB491 combined with Letrozole
Patients were randomized to receive GB491 150 mg orally twice daily, depending on their assignment. Letrozole 2.5 mg orally once a day from the first day of cycle 1 (one cycle every 28 days)
• Placebo combined with Letrozole
Patients were randomized to receive placebo orally twice daily, depending on their assignment. Letrozole 2.5 mg orally once a day from the first day of cycle 1 (one cycle every 28 days)

Locations

Country	Name	City	State
China	Betjing Tiantan Hosptial,Capital Medical University	Beijing	Beijing
China	Chinese PLA General Hospial	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Jilin Cancer Hospital	Changchun	Jilin
China	The First Hospital of Jilin University	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	West China Hospital, Sichuang University	Chengdu	Sichuang
China	Chongqing University Cancer Hospital	Chongqing	Chongqing
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The First People's Hospital of Foshan	Foshan	Guangdong
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	First Affiliated Hospital of Gannan Medical University	Ganzhou	Jiangxi
China	Maternal and Child Healh Hosptal of Guangdong Provrce	Guangzhou	Guangdong
China	Sun Yat-Sen University Cancer Center(Huangpu Campus)	Guangzhou	Guangdong
China	Sun Yat-Sen University Cancer Center(Yuexiu Campus)	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Hainan Medical University	Haikou	Hainan
China	Hangzhou Cancer Hospital	Hangzhou	Zhejiang
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Anhui Cancer Hospital	Hefei	Anhui
China	The First Hospital of Anhui Medical University	Hefei	Anhui
China	The Second Hosptial of Anhui Medical University	Hefei	Anhui
China	Jinan Central Hospital	Jinan	Shandong
China	Shandong Cancer Hospital	Jinan	Shandong
China	Shandong Provincial Hospital	Jinan	Shandong
China	Affiliated Hospital of Jining Medical University	Jining	Shandong
China	Yunnan Cancer Hosptial	Kunming	Yunnan
China	Liaocheng People's Hospital	Liaocheng	Shandong
China	Linyi Cancer Hospital	Linyi	Shandong
China	The First Affiliated Hosptial of Henan University of Science and Technology	Luoyang	Henan
China	Meizhou People's Hosptial	Meizhou	Guangdong
China	Jiangxi Cancer Hospital	Nanchang	Jiangxi
China	The First Affiliated Hosptial of Nanchang University	Nanchang	Jiangxi
China	The Nanchang theird people's Hosptial	Nanchang	Jiangxi
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Guangxi Medical University Cancer Hospital	Nanning	Guangxi
China	Ningbo Medical Center Lihuili Hospital	Ningbo	Zhejiang
China	The Affiliated Hosptial of Qingdao University	Qingdao	Shandong
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Shangrao People's Hospital	Shangrao	Jiangxi
China	Liaoning Cancer Hospital & Institute	Shenyang	Liaoning
China	First Hosptial of Shanxi Medical University	Taiyuan	Shanxi
China	Tianjin Mediacl University Cancer Institute & Hospital	Tianjin	Tianjin
China	The Cancer Affiliated Hospital of Xingjiang Medical University	Ürümqi	Xinjiang
China	The First Hospital of Wenzhou Medical University	Wenzhou	Fujian
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	Xi'an International Medical Center Hospital	Xi'an	Shaanxi
China	The First Affiliated Hosptial of Xiamen University	Xiamen	Fujian
China	Xingtai People's Hospital	Xingtai	Hebei
China	General Hospital of Ningxia Medical University	Yingchuan	Ningxia
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Genor Biopharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator-assessed PFS based on RECIST v1.1	To evaluate progression-free survival (PFS) of GB491 plus Letrozole versus placebo plus Letrozole in HR+/HER2- locally advanced or metastatic breast cancer without prior systemic antitumor therapy (as assessed by the investigator).	Approximately 60 months
Secondary	BICR-assessed PFS based on RECIST v1.1.		Approximately 60 months
Secondary	OS		Approximately 60 months
Secondary	ORR		Approximately 60 months
Secondary	DOR		Approximately 60 months
Secondary	DCR		Approximately 60 months
Secondary	CBR		Approximately 60 months
Secondary	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		Approximately 60 months