2023-506821-12-00进行中（未招募）3 期
A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared with the Physician’s Choice of Endocrine Therapy Plus Everolimus in Patients with Estrogen Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 59
- 试验地点
- 41
- 主要终点
- 1. PFS in the ESR1m subpopulation determined by the investigator
研究概览
简要总结
To evaluate the efficacy of giredestrant plus everolimus compared with the physician’s choice of endocrine therapy plus everolimus in the estrogen receptor 1 mutant subpopulation (ESR1m subpopulation) and in the intent-to-treat (ITT) population on the basis of investigator-assessed progression-free survival (PFS)
研究设计
- 分配方式
- Randomized
- 主要目的
- Overall Design
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Locally advanced unresectable or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
- •Documented estrogen receptor-positive (ER+) tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) or European Society for Medical Oncology (ESMO) guidelines, assessed locally and defined as >= 1% of tumor cells stained positive based on the most recent tumor biopsy (or archived tumor sample)
- •Documented human epidermal growth factor receptor 2 (HER2)-negative tumor assessed locally
- •Ability to provide a blood sample for circulating-tumor deoxyribonucleic acid (ctDNA) ESR1 mutation status determination by central testing prior to study treatment randomization
- •Measurable disease as defined per RECIST v.1.1 or evaluable bone metastases which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed
- •Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE v5.0 Grade ≤ 1
排除标准
- •Prior treatment with another oral selective estrogen receptor degrader (SERD), proteolysis targeting chimera (PROTAC), complete estrogen receptor antagonist (CERAN), novel oral selective estrogen receptor modulator (SERM) or everolimus in any setting. Prior fulvestrant is allowed if treatment was terminated at least 28 days prior to randomization. Prior treatment with tamoxifen is allowed.
- •Progression on more than 2 prior lines of systemic endocrine therapy in the locally advanced unresectable or metastatic breast cancer setting
- •Treatment with strong Cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 14 days or 5 drug elimination half-lives prior to randomization
- •History of any other malignancy other than breast cancer within 5 years prior to screening except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, papillary thyroid cancer treated with surgery, Stage I endometrial cancer or other non-breast cancers at very low risk of recurrence
- •Patients known to be positive for human immunodeficiency viruses (HIV) are excluded if they meet any of the following criteria: - CD4+ T-cell count of < 350 cells/µL - Detectable HIV viral load - History of an opportunistic infection within the past 12 months - On stable antiretroviral therapy for < 4 weeks
- •Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal (GI) surgery including gastric resection, potentially affecting enteral absorption, or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea
结局指标
主要结局
1. PFS in the ESR1m subpopulation determined by the investigator
1. PFS in the ESR1m subpopulation determined by the investigator
2. PFS in the ITT population, determined by the investigator, PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
2. PFS in the ITT population, determined by the investigator, PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
次要结局
- 1. OS after randomization, defined as the time from randomization to death from any cause
- 2.ORR, defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions >= 4 weeks apart, as determined by the investigator according to RECIST v1.1
- 3.DOR, defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
- 4.CBR, defined as the proportion of patients with stable disease for >= 24 weeks or a CR or PR on two consecutive occasions >= 4 weeks apart, as determined by the investigator according to RECIST v1.1
- 5.TTCD in pain severity, defined as the time from randomization to the first documentation of a ≥2-point increase from baseline on the "worst pain" item score from the Brief Pain Inventory-Short Form (BPI-SF) held for two consecutive time points, or a ≥2-point increase followed by death attributable to cancer progression within 28 days from the last assessment
- 6.TTCD in pain presence and interference after randomization, defined as the time from randomization to the first documentation of >= 10-point increase in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core 30 Questionnaire (QLQ-C30) linearly transformed pain scale score held for two consecutive time points, or a >=10-point increase followed by death attributable to cancer progression within 28 days from the last assessment
- 7.TTCD in PF after randomization, defined as the time from randomization to the first documentation of >= 10-point decrease from baseline in the EORTC QLQ-C30 linearly transformed PF scale score held for two consecutive time points, or a >= 10-point decrease followed by death attributable to cancer progression within 28 days from the last assessment
- 8.TTCD in RF after randomization, defined as the time from randomization to the first documentation of >= 10-point decrease from baseline in the EORTC QLQ-C30 linearly transformed RF scale score held for two consecutive time points, or a >= 10-point decrease followed by death attributable to cancer progression within 28 days from the last assessment
- 9.TTCD in HRQoL after randomization, defined as the time from randomization to the first documentation of >= 10-point decrease from baseline in the EORTC QLQ-C30 linearly transformed GHS/QoL scale score held for two consecutive time points, or a >= 10-point decrease followed by death attributable to cancer progression within 28 days from the last assessment
- 10.Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0
- 11.Change from baseline in targeted vital signs
- 12.Change from baseline in targeted clinical laboratory test results
- 13. Plasma concentration of giredestrant at specified timepoints
研究者
US Program Manager Product Development Regulatory
Scientific
Genentech Inc.
研究点 (41)
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