ABOUT THIS STUDY
1. Aged ≥ 18 years, Post-menopausal women
2. Newly diagnosed and operable unilateral invasive breast cancer, not candidate or uncertain for breast conservation - Note: Multicentric/multifocal tumors are allowed provided a maximum of 3 lesions are present, and all share the same characteristics: ER Allred 4, Her2- (PAM50 will be performed in the largest lesion)
3. Stage II-IIIA
4. Assessment of nodal status available (Ultrasound guided FNA or biopsy if necessary)
5. Non metastatic, M0
6. ER-positive by IHC (Allred Score≥4)
7. HER2-negative by IHC (score 0 or 1+) and/or Fish/Cish
8. Either Luminal A AND proven nodal involvement (cytology or histology), or Luminal B through PAM50 ROR (Prosigna™) centralized evaluation
9. ECOG 0-1
10. No prior systemic therapy for the present tumor
11. Adequate renal, hepatic, and hematopoietic functions as defined by the following criteria:
- Absolute Neutrophil Count (ANC) ≥1,500/mm3 or ≥1.5 x 109/L
- Platelets ≥100,000/mm3 or ≥100 x 109/L
- Hemoglobin ≥9 g/dL
- Serum Aspartate Transaminase (AST) and serum Alanine Aminotransferase Transaminase (ALT) ≤2.5 x upper limit of normal (ULN)
- Alkaline phosphatase ≤2.5 x ULN
- Total serum bilirubin ≤1 x ULN
- Serum creatinine ≤1.5 x ULN or estimated creatinine clearance ≥ 60 mL/min as calculated using the method standard for the institution
12. Adequate cardiac functions, including:
- 12 Lead electrocardiogram (ECG) with normal tracing or non clinically significant changes that do not require medical intervention.
- QTc interval ≤480 msec
- No history of Torsades de Pointes or other symptomatic QTc abnormality.
13. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
14. Signed informed consent and health insurance coverage
1. Non operable, bilateral, T4 or metastatic breast cancer
2. Limited T2 breast cancer immediately accessible to conservative surgery
3. Previous homolateral breast cancer (including in situ carcinoma), and/or contralateral
breast cancer except if treated by surgery +/- radiation therapy alone without any
4. Previous hormone replacement therapy (HRT) stopped less than 2 weeks before beginning
5. Previous use of SERMs such as raloxifene
6. Any surgery (not including minor procedures such as lymph node biopsy, primary tumor
core biopsy, fine needle aspiration) within 4 weeks of start of study treatment; or
not fully recovered from any side effects of previous procedures.
7. Diagnosis of any previous malignancy within the last 5 years, except for adequately
treated basal cell carcinoma, or squamous cell skin carcinoma, or in situ cervical
8. History of any previous anti-cancer chemotherapy and any previous treatment using AI
9. Concurrent administration of herbal preparations as complementary medicine.
10. Any clinically significant gastrointestinal abnormalities, which may impair intake,
transit or absorption of the study drugs, such as the inability to take oral
medication in tablet form and malabsorption syndrome
11. 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.
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