Adjuvant Systemic Treatment for (ER)-Positive HER2-negative Breast Carcinoma in Women Over 70 According to Genomic Grade (GG): Chemotherapy + Endocrine Treatment Versus Endocrine Treatment

• Status: Active, not recruiting
• Trial end date: 2026-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of the study is to evaluate the benefit of adjuvant chemotherapy on overall survival for elderly patients with breast cancer, in a sub group with a high risk of relapse according to Genomic Grade test.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Treatments: Aromatase Inhibitors; Cyclophosphamide; Doxorubicin; Tamoxifen

Criteria

Inclusion Criteria:

• Women aged ≥ 70 yo,

• 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: ANC ≥ 1,500/mm3; platelets count ≥ 100,000/mm3; haemoglobin > 9 g/dl,

• Normal hepatic function: total bilirubin ≤ 1.25 ULN; ASAT and ALAT ≤ 1.5 ULN; alkaline phosphatases ≤ 3 ULN,

• Creatinine clearance (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.

Exclusion Criteria:

• Any metastatic impairment, including homolateral sub-clavicular node involvement, regardless of its type,

• 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 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.