Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane, letrozole, or anastrozole, may fight breast cancer by lowering the amount of estrogen the body makes. Giving exemestane, letrozole, or anastrozole before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether exemestane, letrozole, or anastrozole is more effective in treating breast cancer.
PURPOSE: This randomized phase III trial is studying exemestane, letrozole, and anastrozole to compare how well they work in treating postmenopausal women who are undergoing surgery for stage II or stage III breast cancer.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane (25 mg Daily), Letrozole (2.5 mg), or Anastrozole (1 mg) in Postmenopausal Women With Clinical Stage II and III Estrogen Receptor Positive Breast Cancer|
- Clinical response (complete or partial response) rate (cohort A) [ Designated as safety issue: No ]
- Pathological complete response rate to neoadjuvant chemotherapy (cohort B) [ Designated as safety issue: No ]
- Radiological response rate [ Designated as safety issue: No ]
- Adverse events as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Progression-free survival and overall survival [ Designated as safety issue: No ]
- Rate of improvement in surgical outcome [ Designated as safety issue: No ]
- Rate of downstaging to stage I [ Designated as safety issue: No ]
- Rate of lymph node involvement [ Designated as safety issue: No ]
- Pathological complete response rate (cohort A) [ Designated as safety issue: No ]
- Clinical response rate (cohort B) [ Designated as safety issue: No ]
|Study Start Date:||January 2006|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral exemestane once daily for up to 16-18 weeks.
Experimental: Arm II
Patients receive oral letrozole once daily for up to 16-18 weeks.
Experimental: Arm III
Patients receive oral anastrozole once daily for up to 16-18 weeks.
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|United States, Missouri|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis|
|Saint Louis, Missouri, United States, 63110|
|United States, Texas|
|M. D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Doctor's Hospital of Laredo|
|Laredo, Texas, United States, 78041|
|Study Chair:||Matthew J. Ellis, MD, PhD, FRCP||Washington University Siteman Cancer Center|
|Investigator:||John A. Olson, MD, PhD||Duke Cancer Institute|
|Principal Investigator:||Kevin S. Hughes, MD, FACS||Massachusetts General Hospital|