GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer
NCT ID: NCT05054751
Last Updated: 2024-10-10
Study Results
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Basic Information
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COMPLETED
PHASE3
275 participants
INTERVENTIONAL
2021-09-10
2024-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GB491+ Fulvestrant
GB491+ Fulvestrant
GB491: The dose of GB491 is 150 mg, BID, which should be taken with a meal. The drug is administered according to the patient's dose group until the progression of disease or an intolerable toxicity occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial.
Fulvestrant: Intramuscular injection of flurvexine 500mg on day 1 and day 15 of the first cycle, and flurvexine 500mg on day 1 of the second and subsequent cycles. Flurvexine 500mg should be given slowly (1-2 minutes per injection) on both sides of the buttocks, once 250 mg on each side. The drug is administered according to the patient's dose group until the progression of disease or an intolerable toxicity occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial.
Placebo+Fulvestrant
Placebo+Fulvestrant
Placebo: The dose of Placebo is 150 mg, BID, which should be taken with a meal. The placebo is administered according to the patient's dose group until the progression of disease occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial.
Fulvestrant: Intramuscular injection of flurvexine 500mg on day 1 and day 15 of the first cycle, and flurvexine 500mg on day 1 of the second and subsequent cycles. Flurvexine 500mg should be given slowly (1-2 minutes per injection) on both sides of the buttocks, once 250 mg on each side. The drug is administered according to the patient's dose group until the progression of disease or an intolerable toxicity occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial.
Interventions
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GB491+ Fulvestrant
GB491: The dose of GB491 is 150 mg, BID, which should be taken with a meal. The drug is administered according to the patient's dose group until the progression of disease or an intolerable toxicity occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial.
Fulvestrant: Intramuscular injection of flurvexine 500mg on day 1 and day 15 of the first cycle, and flurvexine 500mg on day 1 of the second and subsequent cycles. Flurvexine 500mg should be given slowly (1-2 minutes per injection) on both sides of the buttocks, once 250 mg on each side. The drug is administered according to the patient's dose group until the progression of disease or an intolerable toxicity occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial.
Placebo+Fulvestrant
Placebo: The dose of Placebo is 150 mg, BID, which should be taken with a meal. The placebo is administered according to the patient's dose group until the progression of disease occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial.
Fulvestrant: Intramuscular injection of flurvexine 500mg on day 1 and day 15 of the first cycle, and flurvexine 500mg on day 1 of the second and subsequent cycles. Flurvexine 500mg should be given slowly (1-2 minutes per injection) on both sides of the buttocks, once 250 mg on each side. The drug is administered according to the patient's dose group until the progression of disease or an intolerable toxicity occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically or cytologically confirmed locally advanced or metastatic breast cancer that is not amenable to curative surgical resection or radiation therapy
3. Patients have been diagnosed with ER-positive breast cancer in the local laboratory
4. Patents have been diagnosed with HER2-negative breast cancer in the local laboratory
5. Menopausal status is not limited (including Premenopausal/perimenopausal/postmenopausal state)
6. Prior endocrine therapy and chemotherapy, the following are permitted:
1\) Prior endocrine adjuvant therapy: a) Radiologic evidence of progressive disease (PD) during or within 12 months following (neo)adjuvant therapy with an aromatase inhibitor (AI) or an anti-estrogen such as tamoxifen, and no subsequent endocrine therapy for locally advanced or metastatic breast cancer; b) Radiologic evidence of PD during or within 12 months following (neo)adjuvant therapy with an AI or an anti-estrogen such as tamoxifen, after receiving the first-line endocrine therapy for locally advanced or metastatic breast cancer, and who developed radiologically documented PD after receiving therapy for ≥ 6 months; c) Radiologically documented PD more than 12 months following the end of adjuvant therapy with AIs or anti-estrogens such as tamoxifen, followed by radiographic progression following first-line therapy with AIs or anti-estrogens for locally advanced or metastatic breast cancer; 2) Progression with radiographic evidence of disease following prior first-line endocrine therapy for locally advanced or metastatic breast cancer in subjects who have not received prior (neo) adjuvant therapy; 3) Prior chemotherapy: In addition to endocrine therapy, subjects are eligible if they received a maximum of 1 prior line of chemotherapy for locally advanced or metastatic breast cancer and discontinued treatment for at least 28 days prior to randomization; 7.According to RECIST V1.1, the patient has at least one measurable lesion that has not been irradiated by radiotherapy and can be evaluated by CT/MRI; If there is no measurable lesion, there must be at least one osteolytic bone lesion that can be evaluated by CT/MRI 8.ECOG performance status of 0 or 1 9.Adequate organ and marrow function.
Exclusion Criteria
2. Patients with known hypersensitivity to any component of GB491 or Fulvestrant
3. Known active, uncontrolled, or symptomatic central nervous system metastasis, carcinomatous meningitis, or clinically manifested leptomeningeal disease, cerebral edema, spinal compression or/and tumor progressive growth
4. Visceral crisis
5. Patients with skin lesion only and radiographically non-measurable at baseline
6. Persistent toxicities (CTCAE Grade \>2) caused by previous anticancer therapy, excluding alopecia
7. Patients who have been on bisphosphonates and denosumab therapy at a stable dose for less than 7 days prior to randomization
8. Patients who have received limited field radiotherapy in 2 weeks or extended field radiotherapy in 4 weeks before randomization or radiation with more than 30% of the bone marrow
9. Patients use drugs or fruits containing strong inducers or inhibitors of CYP3A4/5, or drugs with narrow therapeutic window that are mainly metabolized by CYP3A4/5 in 14 days before randomization
10. Patients with long-term systematic use of corticosteroids
11. Any severe and/or uncontrollable medical conditions
12. Patients with severely impaired lung function
13. Known history of HIV infection or history of HIV seropositivity
14. Patients have significant hepatic disease
18 Years
75 Years
ALL
No
Sponsors
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Genor Biopharma Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Binghe Xu, PhD
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Chaoyang Hospital of Capital Medical University
Beijing, Beijing Municipality, China
Cancer hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital , Capital Medical University
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Chognqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The First people's hospital of Foshan
Foshan, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Guangdong provincial TCM hospital
Guangzhou, Guangdong, China
Meizhou People's Hospital
Meizhou, Guangdong, China
Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center Shenzhen Cancer Hospital
Shenzhen, Guangdong, China
Hainan General Hospital
Haikou, Hainan, China
Hainan Third People's Hospital
Sanya, Hainan, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Affiliated hospital of Hebei University
Shijiazhuang, Hebei, China
Harbin Medcial Univercity cancer hospital
Haerbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
The Affiliated hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Jiangxi Provincial Hospital
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
The Second Hospital of Jilin University
Changchun, Jilin, China
Bethune First Hospital Of Jilin University
Changchun, Jillin, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Liaoning Cancer hospital & Institute
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
Shandong Cancer Hospital
Jinan, Shandong, China
Affiliated hospital of Jining Medical University
Jining, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Taian City Central Hospital
Taian, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
The first hospital of Shanxi Medical University
Taiyuan, Shanxi, China
West China School of Medicine
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The Third Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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References
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Xu B, Zhang Q, Luo Y, Tong Z, Sun T, Shan C, Liu X, Yao Y, Zhao B, Wang S, Zeng X, Hu C, Yan X, Wang X, Jia H, Chen Z, Qiu F, Wu X, Zhang D, Li T. Lerociclib plus fulvestrant in patients with HR+/HER2- locally advanced or metastatic breast cancer who have progressed on prior endocrine therapy: LEONARDA-1 a phase III randomized trial. Nat Commun. 2025 Jan 16;16(1):716. doi: 10.1038/s41467-025-56096-2.
Other Identifiers
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GB491-004
Identifier Type: -
Identifier Source: org_study_id
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