NCT05693766招募中2 期
Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT)
Sonya Reid3 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年9月28日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 3
- 主要终点
- Progression free survival
研究概览
简要总结
This is an open-label, multicenter, two-arm Phase II clinical trial that will evaluate the impact of 2nd line chemotherapy (i.e. capecitabine) on survival in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer (MBC)
详细描述
Primary Objective:
- Determine the impact of early chemotherapy (i.e., capecitabine) versus endocrine therapy-based regimen on anti-tumor effect in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer
Secondary Objectives:
- Compare the safety and tolerability of capecitabine versus endocrine therapy in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer
- Determine the impact of early chemotherapy (i.e., capecitabine) versus endocrine therapy-based regimen on anti-tumor effect in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer
Correlatives:
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated written informed consent.
- •Subjects ≥ 18 years of age.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Clinical stage IV invasive mammary carcinoma or unresectable locoregional recurrence of invasive mammary carcinoma that is:
- •ER (>/=1%) and/or PR (>/= 1%) by IHC and HER2 negative (by IHC or FISH)
- •Previously exposed to an aromatase inhibitor (AI) or a selective estrogenreceptor modulator/ downregulator (SERM; SERD) + a CDK4/6 inhibitor.
- •Prior radiation permitted (if completed at least 2 weeks prior to study entry. Patients who have received prior radiotherapy must have recovered from toxicity (≤ grade 1) induced by this treatment (except for alopecia)
- •Patients with brain metastasis secondary to breast cancer and clinically stable for more than 4 weeks from completion of radiation treatment and off steroids
- •Evaluable disease (measurable or non-measurable)
- •Measurable disease, ie, at least 1 measurable lesion as per RECIST 1.1 (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation)
- •Patients with bone only disease allowed if possible to evaluate on radiological exams (eg.bone scan, PET/CT, CT, MRI) even if lesions are non-measurable according to RECIST1.
- •Adequate organ function including:
- •Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
- •Platelets ≥ 100 × 10^9/L
- •Hemoglobin ≥ 8/g/dL (may have been transfused)
- •Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 2.5 × ULN (or ≤ 5 × ULN if liver metastases are present)
- •Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50mL/min as calculated using the Cockcroft-Gault (CG) equation
- •For randomized patients only: tumors must be diagnosed as non-Luminal A using the Blueprint® and Mammaprint® tests
排除标准
- •Prior chemotherapy in the metastatic setting
- •Previous malignant disease other than breast cancer within the last 2 years with associated competing risk, with the exception of basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, or low-risk cancers considered curatively treated (i.e. complete remission achieved at least 2 years prior to first dose of study drugs AND additional therapy not required while receiving study treatment).
- •Persisting symptoms related to prior therapy that has not reduced to Grade 1 [National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5.0]; however, menopausal symptoms, alopecia, and sensory neuropathy Grade ≤ 2 is acceptable
- •Pregnant or breastfeeding females.
研究组 & 干预措施
Physician's Choice of Endocrine-based Therapy_Non-Luminal A subtypes
Active Comparator
干预措施: Endocrine-therapy (Other)
Physician's Choice of Endocrine-based Therapy_Non-Luminal A subtypes
Active Comparator
干预措施: MammoPrint ® and BluePrint assays (Other)
Capecitabine_Non-Luminal A subtypes
Experimental
干预措施: Capecitabine (Drug)
Capecitabine_Non-Luminal A subtypes
Experimental
干预措施: MammoPrint ® and BluePrint assays (Other)
结局指标
主要结局
Progression free survival
时间窗: Up to 3 years
次要结局
- Overall response rate(Up to 3 years)
- Clinical Benefit Rate(Approximately 6 months)
- Incidence of adverse events(Up to 28 days post-treatment)
- Overall survival at 2 years(Up to 2 years)
- Overall impact of treatment toxicity(Up to 3 years)
- Overall survival at 5 years(Up to 5 years)
- Overall survival at 10 years(Up to 10 years)
研究者
Sonya Reid
Assistant Professor of Medicine
Vanderbilt-Ingram Cancer Center
研究点 (3)
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