| Protocol No.: |
NSABP B-42 |
| Title: |
A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Cancer. |
| Staging: |
Stage I, II, or IIIA |
| Objective: |
This study will determine if prolonged adjuvant hormonal therapy will improve disease-free survival in postmenopausal women with ER-positive and/or PgR-positive tumors who have completed 5 years of hormonal therapy with either 5 years of an aromatase inhibitor (AI) or up to 3 years of tamoxifen followed by an AI.
The secondary aims of the study will be to determine whether or not prolonged adjuvant hormonal therapy will improve survival, breast cancer-free interval, and distant recurrence. Additional secondary aims will be to determine whether or not prolonged adjuvant therapy will increase the incidence of osteoporotic-related fractures and arterial thrombotic events. |
| Overview: |
- Post menopausal women who have remained disease-free from the time of initial diagnosis
- Hormone Receptor Positive Breast Cancer
- Completed 5 years of hormonal therapy with either 5 years of an aromatase inhibitor (AI) or up to 3 years of tamoxifen followed by an AI
|
| Eligibility Requirements: |
No requirement.
This protocol has complex eligibility criteria. Please contact us for further information:
Contact Name: Debbie Reynolds, RN, OCN
Contact Phone: 386.254.4213
Contact Email: debbie.reynolds@halifax.org
|
| Contact: |
Center for Oncology
303 N. Clyde Morris Blvd.
Daytona Beach, FL 32114
386.254.4213
Debbie Reynolds, RN, OCN
Center for Oncology
303 N. Clyde Morris Blvd.
Daytona Beach, FL 32114
386.254.4213
Kathleen Brady, RN, BA |
