Study of Anastrozole, Letrozole, or Exemestane With or Without Tamoxifen in Treating Postmenopausal Women With Hormone-Responsive Breast Cancer That Has Been Completely Removed By Surgery
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking use of estrogen by the tumor cells. Anastrozole, letrozole, and exemestane may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether giving tamoxifen followed by anastrozole, letrozole, or exemestane is more effective than giving anastrozole, letrozole, or exemestane alone in treating breast cancer.
PURPOSE: This randomized phase III trial is studying giving tamoxifen followed by either anastrozole, letrozole, or exemestane to see how well it works compared to anastrozole, letrozole, or exemestane alone in treating postmenopausal women with hormone-responsive invasive breast cancer that has been completely removed by surgery.
Drug: tamoxifen citrate
Procedure: adjuvant therapy
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase III Study Comparing Anastrozole, Letrozole and Exemestane, Upfront (for 5 Years) or Sequentially (for 3 Years After 2 Years of Tamoxifen), as Adjuvant Treatment of Postmenopausal Patients With Endocrine-responsive Breast Cancer|
- Disease-free survival [ Designated as safety issue: No ]
- Overall Survival [ Designated as safety issue: No ]
- Distant metastasis-free survival [ Designated as safety issue: No ]
- Cumulative incidence of contralateral breast cancer as first event [ Designated as safety issue: No ]
- Breast cancer-free survival [ Designated as safety issue: No ]
- Cumulative incidence and type of second non-breast invasive cancer [ Designated as safety issue: No ]
- Effects on lipid profile [ Designated as safety issue: No ]
- Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
|Study Start Date:||March 2007|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
- To compare sequential tamoxifen for 2 years followed by anastrozole, letrozole, or exemestane for 3 years vs anastrozole, letrozole, or exemestane for 5 years in terms of disease-free survival in postmenopausal women with nonrecurrent, nonmetastatic invasive endocrine-responsive breast cancer.
- To compare disease-free survival in patients treated with anastrozole vs letrozole vs exemestane.
OUTLINE: This is a multicenter study. Patients are stratified according to hormone receptor status (estrogen receptor [ER]-positive and progesterone [PgR] receptor-positive disease vs ER-positive and PgR-negative disease vs ER-negative and PgR-positive disease vs ER- or PgR-positive disease or ER or PgR status unknown), HER-2/neu status (positive [3+ by IHC or positive by fluorescence in situ hybridization ( FISH)] vs negative vs unknown), prior chemotherapy (none vs adjuvant vs neoadjuvant vs both adjuvant and neoadjuvant), and nodal status (pN0 vs pN1 vs pN2 vs pN3). Patients are randomized to 1 of 6 treatment arms.
- Arm I: Patients receive oral anastrozole once daily for 5 years.
- Arm II: Patients receive oral exemestane once daily for 5 years.
- Arm III: Patients receive oral letrozole once daily for 5 years.
- Arm IV: Patients receive oral tamoxifen citrate once daily for 2 years followed by oral anastrazole once daily for 3 years.
- Arm V: Patients receive oral tamoxifen citrate once daily for 2 years followed by oral exemestane once daily for 3 years.
- Arm VI: Patients receive oral tamoxifen citrate once daily for 2 years followed by oral letrozole once daily for 3 years.
Treatment in all arms continues in the absence of disease recurrence or unacceptable toxicity.
After completion of study therapy, patients are followed periodically.
|Federico II University Medical School||Recruiting|
|Naples, Italy, 80131|
|Contact: Sabino De Placido, MD 39-081-746-3660 firstname.lastname@example.org|
|Istituto Nazionale per lo Studio e la Cura dei Tumori||Recruiting|
|Naples, Italy, 80131|
|Contact: Francesco Perrone, MD 39-81-590-3571|
|Seconda Universita di Napoli||Recruiting|
|Naples, Italy, 80138|
|Contact: Ciro Gallo 39-81-566-6021|
|Arcispedale S. Maria Nuova||Recruiting|
|Reggio Emilia, Italy, 42100|
|Contact: Corrado Boni, MD 39-522-296-546 email@example.com|
|Istituti Fisioterapici Ospitalieri - Roma||Recruiting|
|Rome, Italy, 00128|
|Contact: Francesco Cognetti, MD 39-06-5266-6919 firstname.lastname@example.org|
|Study Chair:||Sabino De Placido, MD||Federico II University|