Clinical trial · Interventional
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
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
NCT01564056CI-TRIAL-00118537ASTER 70scompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CHEMOTHERAPY then HORMONOTHERAPY | Drug | — | UNRESOLVED |
| HORMONOTHERAPY | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Arm A: ENDOCRINE TREATMENT
- description
- HORMONOTHERAPY (Tamoxifen, aromatase inhibitor or sequential hormonotherapy) is left to the investigator judgement in both groups (I and II).
- interventionNames
- Drug: HORMONOTHERAPY
- type
- EXPERIMENTAL
- label
- Arm B: CHEMOTHERAPY + ENDOCRINE TREATMENT
- description
- HORMONOTHERAPY (Tamoxifen, aromatase inhibitor or sequential hormonotherapy) is left to the investigator judgement in both groups (I and II). CHEMOTHERAPY regimen will be chosen amongst the following ones: * TC (docetaxel + cyclophosphamide) * AC (doxorubicin + cyclophosphamide) * MC (liposomal non pegylated doxorubicin \[Myocet®\]+ cyclophosphamide)
- interventionNames
- Drug: CHEMOTHERAPY then HORMONOTHERAPY
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDBrain E, Mir O, Bourbouloux E, Rigal O, Ferrero JM, Kirscher S, Allouache D, D'Hondt V, Savoye AM, Durando X, Duhoux FP, Venat-Bouvet L, Blot E, Canon JL, Rollot-Trad F, Bonnefoi H, Roque T, Lemonnier J, Latouche A, Henriques J, Lacroix-Triki M, Vernerey D; GERICO&UCBG/Unicancer. Adjuvant chemotherapy and hormonotherapy versus adjuvant hormonotherapy alone for women aged 70 years and older with high-risk breast cancer based on the genomic grade index (ASTER 70s): a randomised phase 3 trial. Lancet. 2025 Aug 2;406(10502):489-500. doi: 10.1016/S0140-6736(25)00832-3. PMID 40752909