Safety Study of Adding Everolimus to Adjuvant Hormone Therapy in Women With High Risk of Relapse, ER+ and HER2- Primary Breast Cancer, Free of Disease

Phase 3

Active, not recruiting

• Conditions: Patients with high risk of relapse, ER+ and HER2- primary non-metastatic breast cancer who remain disease-free

• Registration Number: 2024-516198-61-00
• Lead Sponsor: Unicancer

Brief Summary

To evaluate the benefit on disease-free survival (DFS) from adding 2 years everolimus to standard endocrine treatments.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-08-29
• Last Update Posted: 2024-08-30

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Female
• Target Recruitment: 1080

Inclusion Criteria

Female ≥ 18 years of age

Adequate hematological function (neutrophil count  2x109/l, platelet count  100x 109/l)

Adequate hepatic function: AST and ALT ≤ 2.5 ULN, alkaline phosphatases ≤ 2.5 ULN, total bilirubin ≤ 2 ULN.

Adequate renal function: serum creatinine ≤ 1.5 ULN

Signed written informed consent.

Histologically proven invasive unilateral or bilateral breast cancer (regardless of the morphological subtype)

Any T, M0

Patient with high risk of relapse

ER+ and HER2 negative : Hormone receptor positive is defined as any staining on the primary tumor, HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and FISH or CISH non-amplified]

Primary tumor completely resected (deep margins and overlying skin involvement allowed if fully resected)

Patients who will begin an adjuvant hormone therapy or have received a maximum of 4 years of adjuvant hormone therapy. Hormone therapy could be either tamoxifen +/- LH-RH agonists, letrozole, anastrozole or exemestane

No clinically or radiologically detectable metastases at time of inclusion.

WHO Performance status (ECOG) of 0 or 1.

Exclusion Criteria

Any local or regional recurrence or metastatic disease.

Patient with chronic infection

Uncontrolled diabetes defined as glycated haemoglobin , HbA1c>7%

Uncontrolled hypercholesterolemia (cholesterol >300 mg/dl under adequate therapy).

Known hypersensitivity to the active substance, to other rapamycin derivatives or to any of the excipients.

Patient with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study (e.g. patient who regularly require systemic steroids to control co-morbid disease).

Patient with any psychological, familial, social or geographical condition which could potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

Any clinical or radiological suspicion of malignant or pre-malignant disease in the contralateral breast.

Patients with pN1mi as sole nodal involvement

Previous cancer (excepted basal cell carcinoma of the skin or in situ carcinoma of the cervix) in the preceding 5 years, including invasive contralateral breast cancer.

Patient already included in another ongoing therapeutic trial involving an unlicensed drug for which follow-up is required.

Patient who is pregnant or breast-feeding. Adequate birth control measures should be taken during the study treatment phase.

Patient with significantly impaired lung function (e.g. Chronic Obstructive Pulmonary Disease, respiratory insufficiency, Interstitial Lung Disease)

Positive serology for HIV infection or hepatitis C.

Chronic carrier of HBV (positive Antigen HbsAg positive in the blood)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Disease free survival rate (DFS) after randomisation (disease is defined as local, regional or metastatic relapse, a new contralateral breast cancer, or death from any cause).		Disease free survival rate (DFS) after randomisation (disease is defined as local, regional or metastatic relapse, a new contralateral breast cancer, or death from any cause).

Secondary Outcome Measures

Name	Time	Method
Efficacy : DFS and OS for ER+ and PR+ subgroup		Efficacy : DFS and OS for ER+ and PR+ subgroup
Efficacy : DFS and OS for the ER+/PR – subgroup		Efficacy : DFS and OS for the ER+/PR – subgroup
Efficacy : EFS		Efficacy : EFS
Efficacy : DMFS		Efficacy : DMFS
Efficacy : BMFS		Efficacy : BMFS
Efficacy : Secondary cancer		Efficacy : Secondary cancer
Toxicity : CTC-AE scale version 4.0.		Toxicity : CTC-AE scale version 4.0.
Biological : Predictive value of mTOR activation markers on DFS: IHC analysis of primary tumor for pS6K and p4EBP		Biological : Predictive value of mTOR activation markers on DFS: IHC analysis of primary tumor for pS6K and p4EBP
Biological : Other translational analyses linking cancer biology with outcomes		Biological : Other translational analyses linking cancer biology with outcomes
Other : Quality of life: QLQ C30		Other : Quality of life: QLQ C30
Other : EFS and DMFS in low risk patients (according to the EPClin score)		Other : EFS and DMFS in low risk patients (according to the EPClin score)
Other : Sociologic study		Other : Sociologic study
Efficacy : Overall survival rate (OS) for the whole population		Efficacy : Overall survival rate (OS) for the whole population

Trial Locations

Locations (50)

CHU Helora; 🇧🇪 Mons, Belgium

CHR Verviers; 🇧🇪 Verviers, Belgium

Cliniques du Sud-Luxembourg; 🇧🇪 Arlon, Belgium

CHC MontLegia; 🇧🇪 Liege, Belgium

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

Grand Hopital De Charleroi; 🇧🇪 Charleroi, Belgium

Cliniques Saint Luc; 🇧🇪 Bruxelles, Belgium

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

Clinique Pasteur; 🇫🇷 Toulouse Cedex 3, France

Hôpitaux du Leman; 🇫🇷 Thonon-les-bains, France

Scroll for more (40 remaining)

CHU Helora

🇧🇪Mons, Belgium

Vincent RICHARD

Site contact

+3265393739

vincent.richard@hap.be