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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
EU CTIS ID: 2024-516198-61-00
What this study is testing
To evaluate the benefit on disease-free survival (DFS) from adding 2 years everolimus to standard endocrine treatments.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- 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).
See the full eligibility 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.
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.