Overview

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.