Efficacy of Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal Women

Launched by UNICANCER · Mar 26, 2015

Keywords

ClinConnect Summary

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Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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 systemic treatment
• • 4. Previous hormone replacement therapy (HRT) stopped less than 2 weeks before beginning of treatment
• • 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 carcinoma
• • 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.