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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT05851014

Run by

Genor Biopharma Co., Ltd.

People needed

350

Starts

2022-01-14

Expected to finish

2027-01-30

Last updated by the study team

2023-05-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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)

Where it is running

• The First Hospital of Anhui Medical University — Hefei, Anhui, China (enrolling)
• Anhui Cancer Hospital — Hefei, Anhui, China (enrolling)
• The Second Hosptial of Anhui Medical University — Hefei, Anhui, China (enrolling)
• Betjing Tiantan Hosptial，Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Chinese PLA General Hospial — Beijing, Beijing Municipality, China (enrolling)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (enrolling)
• Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (enrolling)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (enrolling)
• The First Hospital of Wenzhou Medical University — Wenzhou, Fujian, China (enrolling)
• The First Affiliated Hosptial of Xiamen University — Xiamen, Fujian, China (enrolling)
• The First People's Hospital of Foshan — Foshan, Guangdong, China (enrolling)
• Sun Yat-Sen University Cancer Center(Huangpu Campus) — Guangzhou, Guangdong, China (enrolling)
• Sun Yat-Sen University Cancer Center(Yuexiu Campus) — Guangzhou, Guangdong, China (enrolling)
• Maternal and Child Healh Hosptal of Guangdong Provrce — Guangzhou, Guangdong, China (enrolling)
• Meizhou People's Hosptial — Meizhou, Guangdong, China (enrolling)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (enrolling)
• The Second Affiliated Hospital of Hainan Medical University — Haikou, Hainan, China (enrolling)
• Xingtai People's Hospital — Xingtai, Hebei, China (enrolling)
• The First Affiliated Hosptial of Henan University of Science and Technology — Luoyang, Henan, China (enrolling)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (enrolling)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• Renmin Hospital of Wuhan University — Wuhan, Hubei, China (enrolling)
• Hubei Cancer Hospital — Wuhan, Hubei, China (enrolling)
• Hunan Cancer Hospital — Changsha, Hunan, China (enrolling)
• The First Affiliated Hospital of Bengbu Medical College — Bengbu, Anhui, China (enrolling)

Full record on ClinicalTrials.gov

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