CYCLOPHOSPHAMIDE for Estrogen receptor-positive HER2-negative breast cancer

Inclusion criteria

• {"criterion_text":"-Women aged ≥ 70 yo,"}
• {"criterion_text":"-Histologically proven invasive breast cancer (regardless of the type),"}
• {"criterion_text":"-Complete surgery performed before enrolment: radical modified mastectomy or breast conservative surgery, with either a sentinel lymph node procedure or axillary lymph node dissection"}
• {"criterion_text":"-Any N status (pN+ or pN0),"}
• {"criterion_text":"-No clinically or radiologically detectable metastases (M0),"}
• {"criterion_text":"-Oestrogen receptor (ER)-positive, as defined by a ≥ 10% tumor stained cells by immunohistochemistry (IHC),"}
• {"criterion_text":"-HER2 negative status (i.e. IHC score 0 or 1+, or IHC score 2+ and FISH/SISH/CISH negative),"}
• {"criterion_text":"-Normal haematological function prior to GG evaluation : ANC ≥ 1,500/mm3; platelets count ≥ 100,000/mm3; haemoglobin > 9 g/dl,"}
• {"criterion_text":"-Normal hepatic function prior to GG evaluation: total bilirubin ≤ 1.25 ULN; ASAT and ALAT ≤ 1.5 ULN; alkaline phosphatases ≤ 3 ULN"}
• {"criterion_text":"-Creatinine clearance prior to GG evaluation (MDRD formula) ≥ 40 mL/min,"}
• {"criterion_text":"-PS (ECOG) ≤ 2,"}
• {"criterion_text":"-Patient able to comply with the protocol,"}
• {"criterion_text":"-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"}
• {"criterion_text":"-Patients must be affiliated to a Social Health Insurance."}

Exclusion criteria

• {"criterion_text":"-Any metastatic impairment,"}
• {"criterion_text":"-Any tumor ≥ T4a (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast cancer),"}
• {"criterion_text":"-ER-negative breast cancer (i.e. <10% tumor stained cells by IHC),"}
• {"criterion_text":"-HER2 overexpression, defined as IHC score 3+ or score 2+ and FISH/SISH/CISH positive"}
• {"criterion_text":"-Any chemotherapy, hormonal therapy or radiotherapy for the current breast cancer before surgery,"}
• {"criterion_text":"-PS (ECOG) ≥ 3,"}
• {"criterion_text":"-Any specific contra-indication to the study drugs (including but not limited to hypersensitivity to the study drugs or their components),"}
• {"criterion_text":"-Patient deprived of freedom or under tutelage,"}
• {"criterion_text":"-Patient unable to comply with the required medical follow-up for geographic, social or psychological reasons."}

Primary endpoints

• {"endpoint_text":"-Overall Survival (OS) with 4 years of follow-up (ie median follow-up = 4 years)","definition_or_measurement_approach":"Overall Survival (OS) measured with 4 years of follow-up (median follow-up = 4 years)."}

Secondary endpoints

• {"endpoint_text":"-Breast cancer-specific survival (BCSS)","definition_or_measurement_approach":"Breast cancer-specific survival (BCSS)."}
• {"endpoint_text":"-Invasive disease-free survival (iDFS)","definition_or_measurement_approach":"Invasive disease-free survival (iDFS)."}
• {"endpoint_text":"-Event-free survival (EFS)","definition_or_measurement_approach":"Event-free survival (EFS)."}
• {"endpoint_text":"-Relapse-free survival (RFS)","definition_or_measurement_approach":"Relapse-free survival (RFS)."}
• {"endpoint_text":"-Evaluation of Toxicity","definition_or_measurement_approach":"Toxicity assessed using NCI-CTC V4.0 (as specified)."}
• {"endpoint_text":"-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","definition_or_measurement_approach":"QoL measured with EORTC QLQ-C30 (v3) and QLQ-ELD15 (elderly module)."}
• {"endpoint_text":"-Q-TWiST analysis","definition_or_measurement_approach":"Quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis as specified."}
• {"endpoint_text":"-Geriatric assessment","definition_or_measurement_approach":"Geriatric assessment including G8 validation in elderly breast cancer population."}
• {"endpoint_text":"-Treatment acceptability","definition_or_measurement_approach":"Treatment acceptability evaluated (willingness test questionnaire)."}
• {"endpoint_text":"-Predictive value of a 4-year mortality score","definition_or_measurement_approach":"Predictive/prognostic value assessment of a 4-year mortality score in elderly cancer population."}
• {"endpoint_text":"-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","definition_or_measurement_approach":"Assessment of genomic grade (GG) by RT-PCR prognostic performance vs routine histopathology."}
• {"endpoint_text":"-Cost-effectiveness analysis","definition_or_measurement_approach":"Medico-economic/cost-effectiveness analysis of adjuvant chemotherapy introduction for women >70 with high relapse risk per GG."}
• {"endpoint_text":"-Follow-up of a cohort of elderly BC patients not treated with adjuvant chemotherapy (including non eligibility due to GG).","definition_or_measurement_approach":"Cohort follow-up of non-treated elderly breast cancer patients (including those ineligible due to GG)."}
• {"endpoint_text":"-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.","definition_or_measurement_approach":"Ancillary analysis in France: prognostic value of HalioDx GG on iDFS and distant DFS/D-RFS in first 500 screened patients with 36-month follow-up."}

Belgium

Earliest CTIS Part Ii Submission Date

01-08-2024

Latest Decision Or Authorization Date

17-09-2024

Processing Time Days

47

Number Of Participants

149

France

Earliest CTIS Part Ii Submission Date

01-08-2024

Latest Decision Or Authorization Date

31-10-2024

Processing Time Days

91

Number Of Participants

1840

Primary sponsor

Full Name

Unicancer

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France