Chemotherapy or chemotherapy + hormonotherapy in women over 70 with HER2 receptor-negative but estrogen receptor-positive breast cancer according to their genomic grade

Phase 3

Active, not recruiting

• Conditions: oestrogen-receptor (ER)-positive HER2-negative breast carcinoma

• Registration Number: 2024-516996-34-00
• Lead Sponsor: Unicancer

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-09-17
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Female
• Target Recruitment: 1989

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Breast cancer-specific survival (BCSS)		Breast cancer-specific survival (BCSS)
Invasive disease-free survival (iDFS)		Invasive disease-free survival (iDFS)
Event-free survival (EFS)		Event-free survival (EFS)
Relapse-free survival (RFS)		Relapse-free survival (RFS)
Evaluation of Toxicity		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		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		Q-TWiST analysis
Geriatric assessment		Geriatric assessment
Treatment acceptability		Treatment acceptability
Predictive value of a 4-year mortality score		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		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		Cost-effectiveness analysis
Follow-up of a cohort of elderly BC patients not treated with adjuvant chemotherapy (including non eligibility due to GG).		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.		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.

Trial Locations

Locations (70)

Centre Hospitalier D`Ardenne - Forget; 🇧🇪 Libramont, Belgium

Cliniques du Sud-Luxembourg; 🇧🇪 Arlon, Belgium

centre Hospitalier de Wallonie Picarde; 🇧🇪 Tournai, Belgium

Cliniques Saint Luc; 🇧🇪 Bruxelles, Belgium

CHU UCL Namur - Site Godinne; 🇧🇪 Yvoir, Belgium

Centre Hospitalier Universitaire HELORA - Hôpital de Mons; 🇧🇪 MONS, Belgium

Clinique Saint-Pierre; 🇧🇪 Ottignies-Louvain-La-Neuve, Belgium

CHC Saint-Joseph; 🇧🇪 Liège, Belgium

Grand Hopital De Charleroi; 🇧🇪 Charleroi, Belgium

Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur; 🇧🇪 Namur, Belgium

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Centre Hospitalier D`Ardenne - Forget

🇧🇪Libramont, Belgium

Frédéric FORGET

Site contact

3261238858

frederic.forget@cha.be