An Umbrella Trial Based on Molecular Pathway for Patients With Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer (FUTURE SUPER)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This is a Phase II, open-label, randomized controlled umbrella trial evaluating the efficacy and safety of multiple targeted treatment in patients with metastaticTNBC.
详细描述
This is a Phase II, open-label, randomized controlled umbrella trial evaluating the efficacy and safety of multiple targeted treatment vs. traditional chemotherapy in patients with unresectable locally advanced or metastatic triple negative breast cancer. The specific grouping of patients' depends on FUSCC 500+ gene panel testing and IHC subtype staining.These tests would be done on their rebiopsy tumor specimen. Specifically, as to TNBC molecular subtyping,FUSCC data identified the genomic aberrations that drive each TNBC subtype by applying an integrative analysis combining somatic mutation, copy number aberrations (CNAs) and gene expression profiles, which classified TNBC patients into four subtypes, namely luminal androgen receptor (LAR), immunomodulatory (IM), basal-like immune suppressed (BLIS), and mesenchymal-like (MES). Then, FUSCC conducted a IHC subtyping model to replace complex genomic sequencing, which have been validated in FUSCC cohort.FUSCC 500+ gene panel was developed combining public database(TCGA, METABRIC, 560WES, MSKCC-IMPACT ect.) and FUSCC private TNBC database.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ECOG Performance Status of 0-1
- •Expected lifetime of not less than three months
- •Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
- •Cancer stage: recurrent or metastatic breast cancer; Local recurrence be confirmed by the researchers could not be radical resection.
- •Adequate hematologic and end-organ function, laboratory test results, obtained within 14 days prior to initiation of study treatment.
- •Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
- •Patients had received no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer
- •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm
- •Have the cognitive ability to understand the protocol and be willing to participate and to be followed up.
排除标准
- •Symptomatic, untreated, or actively progressing CNS metastases
- •Active or history of autoimmune disease or immune deficiency
- •Active hepatitis B or hepatitis C
- •Significant cardiovascular disease
- •History of malignancy other than breast cancer within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death
- •Treatment with taxel-based chemotherapy within 6 months
- •Treatment with chemotherapy, radiotherapy,immunotherapy or surgery (outpatient clinic surgery excluded)within3 weeks prior to initiation of study treatment.
- •Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- •Previous received anti-VEGFR small molecule tyrosine kinase inhibitors (e.g. famitinib, sorafenib, Sunitinib, regorafenib, etc.) for treatment of the patients .
- •A history of bleeding, any serious bleeding events.
- •Important blood vessels around tumors has been infringed and high risk of bleeding.
- •Long-term unhealing wound or incomplete healing of fracture
- •Urine protein ≥2+ and 24h urine protein quantitative > 1 g.
- •Arrhythmia for long-term use of anti-arrhythmic drugs and New York heart association class II or higher cardiac insufficiency
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: approximately 3 years
Refers to the time between the patient's enrollment and any recorded tumor progression or death from any cause.
次要结局
- Overall Survival (OS)(approximately 3 years)
- Objective response rate (ORR)(approximately 3 years)
- Duration of Response (DoR)(approximately 3 years)
- Disease Control Rate (DCR)(approximately 3 years)
- Safety: Adverse Events (AE)(approximately 3 years)
研究者
Zhimin Shao
Director of General Surgery of Fudan Shanghai Cancer Center
Fudan University