Status:
ACTIVE_NOT_RECRUITING
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 After Receiving at Least One Year of Adjuvant Hormone Therapy
Lead Sponsor:
UNICANCER
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Primary Non-metastatic Breast Cancer
Who Remain Disease-free
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
A significant number of patients relapse and eventually die, particularly if they were initially diagnosed with large nodes involvement and/or T3/4 diseases. When analyses focus on patients with ER+/H...
Eligibility Criteria
Inclusion
- Female ≥18 years of age,
- Histologically proven invasive unilateral or bilateral breast cancer (regardless of the morphological subtype),
- Any T, M0
- Patient with high risk of relapse according to one of the conditions below:
- at least 4 positive lymph nodes if the patient had primary surgery
- or at least 1 positive lymph node if surgery was conducted after neo adjuvant chemotherapy or hormone therapy of at least 3 months duration
- or 1-3 positive lymph nodes (pN1a, b, c) at primary surgery AND EPClin score ≥3.32867 Note: Access to primary tumor for patients with 1-3 node positive is mandatory. Patient with EPClin score \<3.32867 will not be randomized, but will be followed yearly during 10 years
- 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 +/- 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.
- Adequate hematological function (neutrophil count ≥2x10⁹/L; platelet count ≥ 100x10⁹/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
Exclusion
- Any local, or regional recurrence or metastatic disease
- 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)
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2030
Estimated Enrollment :
1278 Patients enrolled
Trial Details
Trial ID
NCT01805271
Start Date
March 1 2013
End Date
June 1 2030
Last Update
May 14 2025
Active Locations (2)
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1
Centre Leon Berard
Lyon, France
2
Gustave Roussy
Villejuif, France