Letrozole for Hormone Receptor-Positive Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether letrozole, a hormone therapy, can more effectively treat breast cancer by lowering estrogen levels compared to a placebo. It targets postmenopausal women who have already undergone hormone therapy for hormone receptor-positive breast cancer. Eligible participants must have remained disease-free since their breast cancer diagnosis and completed about five years of hormonal therapy. The trial seeks to determine if letrozole can prevent breast cancer recurrence more effectively than taking no active medication. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the chance to contribute to potentially groundbreaking advancements in breast cancer treatment.
Do I need to stop my current medications for the trial?
Yes, you will need to stop certain medications. If you are on sex hormonal therapy or medications like raloxifene for osteoporosis, you must discontinue them before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that letrozole is generally well-tolerated by patients. In a study with Korean postmenopausal women who had estrogen receptor-positive breast cancer, letrozole treatment led to good results and was well-tolerated. Another study found that letrozole's safety was similar to that of another breast cancer treatment, anastrozole, suggesting that severe side effects are uncommon.
Moreover, long-term survival rates are encouraging. Specifically, one study found that the five-year survival rate for patients taking letrozole was very high, around 95%. This high rate supports the idea that letrozole is safe for long-term use in treating breast cancer.
Overall, letrozole appears to be a safe treatment option with manageable side effects for those with hormone receptor-positive breast cancer.12345Why do researchers think this study treatment might be promising?
Letrozole is unique because it specifically targets hormone receptor-positive breast cancer by inhibiting aromatase, an enzyme involved in estrogen production. Unlike other treatments that might use chemotherapy or rely on tamoxifen, letrozole directly reduces estrogen levels, which can slow or stop the growth of certain cancer cells. Researchers are excited about letrozole because it offers a more targeted approach, potentially leading to fewer side effects compared to broader treatments, while maintaining effectiveness over a long duration.
What evidence suggests that letrozole might be an effective treatment for hormone receptor-positive breast cancer?
Research has shown that letrozole, which participants in this trial may receive, can effectively treat hormone receptor-positive breast cancer. One study found that letrozole significantly reduced the risk of cancer recurrence, resulting in fewer cases of recurrence. Specifically, it increased the time patients remained free from breast cancer by 25% compared to those not taking letrozole. Another study discovered that combining letrozole with ribociclib extended patients' lives, with an average survival time of 63.9 months. These findings suggest that letrozole is a strong option for managing this type of breast cancer.14678
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