NCT05054751已完成3 期
A Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial of GB491 Combined With Fulvestrant in Subjects With HR+, HER2- Locally Advanced or Metastatic Breast Cancer Who Have Progressed on Prior Endocrine Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 275
- 试验地点
- 54
- 主要终点
- PFS assessed by the investigator
研究概览
简要总结
GB491-004 is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of GB491 in combination with fulvestrant in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer who have progressed on prior endocrine therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females or males of 18 years of age or older and less than 75 years of age at study screening
- •Histologically or cytologically confirmed locally advanced or metastatic breast cancer that is not amenable to curative surgical resection or radiation therapy
- •Patients have been diagnosed with ER-positive breast cancer in the local laboratory
- •Patents have been diagnosed with HER2-negative breast cancer in the local laboratory
- •Menopausal status is not limited (including Premenopausal/perimenopausal/postmenopausal state)
- •Prior endocrine therapy and chemotherapy, the following are permitted:
- •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.
排除标准
- •Previous treatment with fulvestrant, everolimus or any other CDK4/6 inhibitors
- •Patients with known hypersensitivity to any component of GB491 or Fulvestrant
- •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
- •Visceral crisis
- •Patients with skin lesion only and radiographically non-measurable at baseline
- •Persistent toxicities (CTCAE Grade >2) caused by previous anticancer therapy, excluding alopecia
- •Patients who have been on bisphosphonates and denosumab therapy at a stable dose for less than 7 days prior to randomization
- •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
- •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
- •Patients with long-term systematic use of corticosteroids
- •Any severe and/or uncontrollable medical conditions
- •Patients with severely impaired lung function
- •Known history of HIV infection or history of HIV seropositivity
- •Patients have significant hepatic disease
研究组 & 干预措施
GB491+ Fulvestrant
Experimental
干预措施: GB491+ Fulvestrant (Drug)
Placebo+Fulvestrant
Placebo Comparator
干预措施: Placebo+Fulvestrant (Drug)
结局指标
主要结局
PFS assessed by the investigator
时间窗: Approximately 1.5 years
To assess the PFS assessed by the investigator
次要结局
- PFS assessed by the blinded independent central review (BICR)(Approximately 1.5 years)
- OS(Approximately 3 years)
- ORR(Approximately 1.5 years)
- DOR(Approximately 1.5 years)
- DCR(Approximately 1.5 years)
- CBR(Approximately 1.5 years)
- Safety and tolerability(Approximately 3 years)
- PK(From Cycle 1 to Cycle 4, approximately 4 months)
研究者
研究点 (54)
Loading locations...
相似试验
已完成
3 期
A Study of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （CROWNS-2）Chronic Rhinosinusitis With Nasal PolyposisNCT05436275Keymed Biosciences Co.Ltd180
已完成
3 期
A Study of CS1001 in Subjects With Stage III Non-Small Cell Lung CancerNon-Small Cell Lung Cancer Stage IIINCT03728556CStone Pharmaceuticals381
已完成
3 期
A Study Comparing Bevacizumab Therapy With or Without Erlotinib for First-Line Treatment of Non-Small Cell Lung Cancer (ATLAS)Non-Small Cell Lung CancerNCT00257608Genentech, Inc.1,145
已完成
3 期
A Study of IBI362 in Participants With Obesity or OverweightObesity Or OverweightNCT05607680Innovent Biologics (Suzhou) Co. Ltd.610
终止
3 期
A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following NephrectomyRenal Cell CarcinomaNCT03024996Hoffmann-La Roche778