Efficacy of Anastrozole and Fulvestrant in Patients With ER Positive, HER2 Negative, Operable Breast Cancer (NIMFEA)
|ClinicalTrials.gov Identifier: NCT00629616|
Recruitment Status : Unknown
Verified August 2014 by UNICANCER.
Recruitment status was: Active, not recruiting
First Posted : March 6, 2008
Last Update Posted : August 6, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: anastrozole Drug: fulvestrant||Phase 2|
- 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 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Multicenter Phase II Study Identifying Hormone Sensitivity Profiles and Evaluating the Efficacy of Anastrozole and Fulvestrant in the Neo-adjuvant Treatment of Operable Breast Cancer in Postmenopausal Women.|
|Study Start Date :||August 2007|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||September 2016|
Experimental: Arm A
1 mg/day for either 4 months or 6 months depending on the clinical evaluation
Experimental: Arm B
500mg at day 1, day 15 and day 29 500mg every 28 days for either 4 months or 6 months depending on the clinical evaluation
- Clinical tumor response as assessed by RECIST criteria [ Time Frame: 6 months ]
- Breast surgery conservation rate [ Time Frame: Post surgery ]
- Histological tumor response as assessed by the Sataloff scale [ Time Frame: Post surgery ]
- Tumor response as assessed by mammography, ultrasonography (RECIST criteria), and MRI [ Time Frame: at baseline, after the first month of treatment, and then before surgery ]
- Biological prognosis and predictive response factors [ Time Frame: 3 years ]
- Relapse-free survival rate [ Time Frame: 3 years ]
- Event-free survival rate [ Time Frame: 3 years ]
- Overall survival rate [ Time Frame: 3 years ]
- Toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: During neoadjuvant treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00629616
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Limoges Cedex, France, 87042|
|Institut Curie Hopital|
|Paris, France, 75248|
|Centre Eugene Marquis|
|Rennes, France, 35042|
|Centre Rene Huguenin|
|Saint-Cloud, France, 92210|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Principal Investigator:||Florence Lerebours, MD||Institut Curie|