A Randomized Multicenter Phase II Study Identifying Hormonosensivity Profiles and Evaluating the Efficacy of Anastrozole and Fulvestrant in the Neo-adjuvant Treatment of Operable Breast Cancer in Postmenopausal Women.
- To compare the clinical response rates (complete and partial responses) at 6 months in
postmenopausal women with operable stage II or III breast cancer treated with
neoadjuvant anastrozole vs fulvestrant.
- To compare the breast surgery conservation rate in patients treated with these drugs.
- To correlate imaging findings by mammography, ultrasonography, and MRI with
histological and clinical response in these patients and with sensitivity profile to
- To compare histological response in patients treated with these drugs.
- To define criteria appropriate for neoadjuvant hormonal therapy.
- To correlate baseline molecular characteristics and modifications during treatment with
response in these patients.
- To compare the tolerability of these drugs in these patients.
- To compare the serum proteomic profile of patients treated with these drugs.
- To correlate 3-year event-free and overall survival rates with clinical and
histological response in these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral anastrozole once daily for 4-6 months in the absence of
- Arm II: Patients receive fulvestrant intramuscularly on days 1, 15, and 29 in the first
month and then every 28 days in each subsequent month. Treatment continues for 4-6
months in the absence of clinical progression.
Patients in both arms then undergo surgery and radiotherapy according to institutional
guidelines. Patients then receive adjuvant hormonal therapy for at least 5 years.
After completion of study therapy, patients are followed periodically for up to 3 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical tumor response as assessed by RECIST criteria
Florence Lerebours, MD
Centre Rene Huguenin
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)