Efficacy of Anastrozole and Fulvestrant in Patients With ER Positive, HER2 Negative, Operable Breast Cancer
- Registration Number
- NCT00629616
- Lead Sponsor
- UNICANCER
- Brief Summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole or fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes or by blocking the use of estrogen by the tumor cells. Giving hormone therapy before surgery may be an effective treatment for breast cancer. It is not yet known whether anastrozole is more effective than fulvestrant when given before surgery in treating women with breast cancer.
PURPOSE: This randomized phase II trial is studying anastrozole to see how well it works compared with fulvestrant in treating postmenopausal women with stage II or stage III breast cancer that can be removed by surgery.
- Detailed Description
OBJECTIVES:
Primary
* 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.
Secondary
* 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 these drugs.
* 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 clinical progression.
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 116
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B fulvestrant Fulvestrant Arm A anastrozole Anastrozole
- Primary Outcome Measures
Name Time Method Clinical tumor response as assessed by RECIST criteria 6 months
- Secondary Outcome Measures
Name Time Method Relapse-free survival rate 3 years Histological tumor response as assessed by the Sataloff scale Post surgery Overall survival rate 3 years Tumor response as assessed by mammography, ultrasonography (RECIST criteria), and MRI at baseline, after the first month of treatment, and then before surgery Event-free survival rate 3 years Breast surgery conservation rate Post surgery Biological prognosis and predictive response factors 3 years Toxicity as assessed by NCI CTCAE v3.0 During neoadjuvant treatment
Trial Locations
- Locations (6)
Institut Gustave Roussy
🇫🇷Villejuif, France
Hopital Dupuytren
🇫🇷Limoges Cedex, France
Centre Eugene Marquis
🇫🇷Rennes, France
Centre Rene Huguenin
🇫🇷Saint-Cloud, France
Institut Curie Hopital
🇫🇷Paris, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France