Letrozole for Hormone Receptor-Positive Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating patients with hormone receptor-positive breast cancer.PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating postmenopausal women who have received hormone therapy for hormone receptor-positive breast cancer.
Who Is on the Research Team?
Norman Wolmark, MD
Principal Investigator
NSABP Foundation Inc
Are You a Good Fit for This Trial?
This trial is for postmenopausal women who have been disease-free since their initial breast cancer diagnosis and completed 57-63 months of hormone therapy. They must have had estrogen or progesterone receptor-positive tumors, undergone specific surgeries with axillary nodal staging, and be in good physical condition (ECOG status 0 or 1). Women on sex hormonal therapies or with certain health conditions are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral letrozole or placebo once daily for up to 5 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Letrozole
- Placebo
Letrozole is already approved in United States, European Union, Canada for the following indications:
- Breast cancer in postmenopausal women
- Increasing the chance of ovulation in women with polycystic ovary syndrome
- Early breast cancer in postmenopausal women
- Advanced breast cancer in postmenopausal women
- Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
- First-line treatment of postmenopausal women with hormone receptor-positive advanced breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
NSABP Foundation Inc
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Novartis
Industry Sponsor
Vasant Narasimhan
Novartis
Chief Executive Officer since 2018
MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government
Shreeram Aradhye
Novartis
Chief Medical Officer since 2022
MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania