2024-516996-34-00招募中3 期
GERICO11_Adjuvant systemic treatment for oestrogen-receptor (ER)-positive HER2-negative breast carcinoma in women over 70 according to Genomic Grade (GG): chemotherapy + endocrine treatment versus endocrine treatment. A French UNICANCER Geriatric Oncology Group (GERICO) and Breast Group (UCBG) multicentre phase III trial
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Unicancer
- 入组人数
- 1,989
- 试验地点
- 70
- 主要终点
- Overall Survival (OS) with 4 years of follow-up (ie median follow-up = 4 years)
研究概览
简要总结
Evaluation of the benefit of adjuvant chemotherapy on overall survival (OS) in the sub group of elderly patients with a high risk of relapse according to Genomic Grade (GG).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥ 70 yo,
- •Creatinine clearance prior to GG evaluation (MDRD formula) ≥ 40 mL/min,
- •PS (ECOG) ≤ 2,
- •Patient able to comply with the protocol,
- •Patients must have signed a written informed consent form prior to any study specific procedures, including the agreement for the use of archived tumoral material for genomic screening and data collection
- •Patients must be affiliated to a Social Health Insurance.
- •Histologically proven invasive breast cancer (regardless of the type),
- •Complete surgery performed before enrolment: radical modified mastectomy or breast conservative surgery, with either a sentinel lymph node procedure or axillary lymph node dissection
- •Any N status (pN+ or pN0),
- •No clinically or radiologically detectable metastases (M0),
- •Oestrogen receptor (ER)-positive, as defined by a ≥ 10% tumor stained cells by immunohistochemistry (IHC),
- •HER2 negative status (i.e. IHC score 0 or 1+, or IHC score 2+ and FISH/SISH/CISH negative),
- •Normal haematological function prior to GG evaluation : ANC ≥ 1,500/mm3; platelets count ≥ 100,000/mm3; haemoglobin > 9 g/dl,
- •Normal hepatic function prior to GG evaluation: total bilirubin ≤ 1.25 ULN; ASAT and ALAT ≤ 1.5 ULN; alkaline phosphatases ≤ 3 ULN
排除标准
- •Any metastatic impairment,
- •Any tumor ≥ T4a (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast cancer),
- •ER-negative breast cancer (i.e. <10% tumor stained cells by IHC),
- •HER2 overexpression, defined as IHC score 3+ or score 2+ and FISH/SISH/CISH positive
- •Any chemotherapy, hormonal therapy or radiotherapy for the current breast cancer before surgery,
- •PS (ECOG) ≥ 3,
- •Any specific contra-indication to the study drugs (including but not limited to hypersensitivity to the study drugs or their components),
- •Patient deprived of freedom or under tutelage,
- •Patient unable to comply with the required medical follow-up for geographic, social or psychological reasons.
结局指标
主要结局
Overall Survival (OS) with 4 years of follow-up (ie median follow-up = 4 years)
Overall Survival (OS) with 4 years of follow-up (ie median follow-up = 4 years)
次要结局
- Breast cancer-specific survival (BCSS)
- Invasive disease-free survival (iDFS)
- Event-free survival (EFS)
- Relapse-free survival (RFS)
- Evaluation of Toxicity
- Quality of life: Quality of life (QoL) will be assessed using the national version of EORTC QLQ-C30 (version 3) and QLQ-ELD15, a QLQ C30 supplement module for the assessment of quality of life in the elderly patient with cancer
- Q-TWiST analysis
- Geriatric assessment
- Treatment acceptability
- Predictive value of a 4-year mortality score
- Usefulness of GG by RT-PCR as a prognostic signature and performance in an elderly population by comparison to standardized routine histopathological criteria and to the results obtained in the general non elderly population
- Cost-effectiveness analysis
- Follow-up of a cohort of elderly BC patients not treated with adjuvant chemotherapy (including non eligibility due to GG).
- Ancillary study criterai (Only applicable for France): The prognostic value of HalioDx GG testing on iDFS and D-DFS/D-RFS will be assessed in the first 500 patients in the screened population (cohort group and randomized group [in both arms]) with a follow-up of 36 months.
研究者
Nourredine AIT RAHMOUNE
Scientific
Unicancer
研究点 (70)
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