A trial of everolimus in women with breast cancer

Phase 1

Conditions: ER+, HER2- early breast cancer
MedDRA version: 20.0Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-003187-44-GB

Lead Sponsor: ICANCER

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 1984

Inclusion Criteria

1. Female = 18 years of age
2. Histologically proven invasive unilateral or bilateral breast cancer (regardless of the morphological subtype)
3. Any T, M0 (according to the American Joint Committee on Cancer classification)
4. 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
5. 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]
6. Primary tumor completely resected (deep margins and overlying skin involvement allowed if fully resected)
7. Patients who have received at least 1 year but not more than 4 years of adjuvant hormone therapy. Hormone therapy could be either tamoxifen, letrozole, anastrozole or
exemestane.
8. No clinically or radiologically detectable metastases at time of inclusion.
9. WHO Performance status (ECOG) of 0 or 1.
10. Adequate hematological function (neutrophil count ? 2x109/l, platelet count ? 100x 109/l)
11. Adequate hepatic function: AST and ALT = 2.5 ULN, alkaline phosphatases = 2.5 ULN, total bilirubin = 2 ULN.
12. Adequate renal function: serum creatinine = 1.5 ULN.
13. Signed written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250

Exclusion Criteria

1. Any local, or regional recurrence or metastatic disease.
2. Any clinical or radiological suspicion of malignant or pre-malignant disease in the contralateral breast.
3. 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.
4. Patient already included in another ongoing therapeutic trial involving an unlicensed drug for which follow-up is required.
5. Patient who is pregnant or breast-feeding. Adequate birth control measures should be taken during the study treatment phase.
6. Patient with significantly impaired lung function (e.g. Chronic Obstructive Pulmonary Disease, respiratory insufficiency, Interstitial Lung Disease)
7. Positive serology for HIV infection or hepatitis C.
8. Chronic carrier of HBV (positive Antigen HbsAg positive HbS in the blood)
9. Patient with chronic infection
10. Uncontrolled diabetes defined as glycated haemoglobinemia , HbA1c>7%
11. Uncontrolled hypercholesterolemia (cholesterol >300 mg/dl under adequate therapy).
12. Known hypersensitivity to the active substance, to other rapamycin derivatives or to any of the excipients.
13. 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).
14. 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.
15. Patients with pN1mi as sole nodal involvement