NCT03659136已完成2 期
XENERA™1: A Multi-centre, Double-blind, Placebo-controlled, Randomised Phase II Trial to Compare Efficacy of Xentuzumab in Combination With Everolimus and Exemestane Versus Everolimus and Exemestane in Women With HR+ / HER2- Metastatic Breast Cancer and Non-visceral Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 54
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The main objective of the trial is to assess the efficacy of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in patients with HR+/ HER2- advanced or metastatic breast cancer and non-visceral disease.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Documented histologically confirmed breast cancer with ERand/ or PgR-positive and HER2-negative status
- •Locally advanced or metastatic breast cancer not deemed amenable to curative surgery or curative radiation therapy
- •Archival tumour sample available at the time of informed consent and provided to the central laboratory around the time of randomisation. Patients must provide a formalin-fixed paraffin embedded (FFPE) tissue biopsy sample preferably taken at the time of presentation with recurrent or metastatic disease (provision of a biopsy sample taken from the bone is not acceptable).
- •Patients must satisfy the following criteria for prior therapy:
- •Disease progression during treatment or within 12 months of completion of endocrine adjuvant therapy or
- •Disease progression while on or within 1 month after the end of prior endocrine therapy for advanced/metastatic breast cancer (Note: the endocrine therapy does not have to be the treatment immediately prior to trial entry).
- •Patients must have
- •At least one measurable non-visceral lesion according to RECIST version 1.1 in either lymph nodes, soft tissue, skin and/or
- •At least one measurable non-visceral lesion according to RECIST version 1.1 as lytic or mixed (lytic + blastic) in bone and/or
- •At least one non-measurable (lytic, mixed lytic + blastic, or blastic) bone lesion according to RECIST version 1.1
- •Eastern Cooperative Oncology Group (ECOG) performance score 0 or
- •Fasting glucose <8.9 mmol/L (<160 mg/dL) and HbA1c <8.0%
- •Adequate organ function
排除标准
- •Previous treatment with agents targeting the IGF pathway, AKT, or mTOR pathways
- •Prior treatment with exemestane (except adjuvant exemestane stopped >12 months prior to start of study treatment as long as the patient did not recur during or within 12 months after the end of adjuvant exemestane)
- •Evidence of visceral metastasis/es (i.e. liver, lung, peritoneal, pleural metastases, malignant pleural effusions, malignant peritoneal effusions) at screening. NOTE: Patients with a past history of visceral metastases are eligible if visceral metastases have completely resolved at least 3 months
- •History or evidence of metastatic disease to the brain
- •Leptomeningeal carcinomatosis
- •More than 1 prior line of chemotherapy for HR+ HER2- metastatic breast cancer
- •Radiotherapy within 4 weeks prior to the start of study treatment
- •Use of concomitant systemic sex hormone therapy
- •History or presence of cardiovascular abnormalities
- •Known pre-existing interstitial lung disease
- •Further exclusion criteria apply
研究组 & 干预措施
Xentuzumab/everolimus/exemestane
Experimental
干预措施: Xentuzumab (Drug)
Xentuzumab/everolimus/exemestane
Experimental
干预措施: Everolimus (Drug)
Xentuzumab/everolimus/exemestane
Experimental
干预措施: Exemestane (Drug)
Placebo/everolimus/exemestane
Placebo Comparator
干预措施: Placebo (Drug)
Placebo/everolimus/exemestane
Placebo Comparator
干预措施: Everolimus (Drug)
Placebo/everolimus/exemestane
Placebo Comparator
干预措施: Exemestane (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: From randomisation until the earliest of disease progression, death or the time point of primary PFS analysis, up to 892 days.
Progression-free survival (PFS) defined as the time from randomisation until progressive disease (PD) according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) in combination with modified MD Anderson Criteria (for bone lesion assessment), based on blinded independent assessment or death from any cause, whichever occurred earlier. As per RECIST, PD is defined as at least a 20% increase in the sum of diameters of target lesions, unequivocal progression of non-target lesions or the appearance of new lesions.
次要结局
- Overall Survival (OS)(From randomisation until death from any cause, up to 995 days.)
- Number of Patients With Disease Control (DC)(From randomisation until the earliest of progressive disease or death from any cause, up to 892 days.)
- Duration of Disease Control (DC)(From randomisation until the earliest of progressive disease or death from any cause, up to 892 days.)
- Number of Participants With Objective Response (OR)(From randomisation until end of treatment, up to 892 days.)
- Time to Pain Progression or Intensification of Pain Palliation(From randomisation until the earliest of pain progression, intensification of pain palliation, death or the time point of progression free survival analysis, up to 843 days.)
研究者
研究点 (54)
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