Hormone Therapy +/− Everolimus for Breast Cancer
(e3 Trial)
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 tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot take certain drugs like strong CYP3A4 inhibitors or inducers during the study. It's best to discuss your current medications with the study team to see if any adjustments are needed.
Is hormone therapy with or without Everolimus safe for breast cancer treatment?
Hormone therapies like letrozole and tamoxifen are generally safe but have different side effects. Letrozole may increase the risk of bone fractures and heart issues, while tamoxifen may increase the risk of uterine cancer and blood clots. Always discuss potential side effects with your doctor.12345
How does the drug combination of hormone therapy and Everolimus differ from other breast cancer treatments?
This drug combination is unique because it combines hormone therapy with Everolimus, a drug that inhibits a protein called mTOR, which can enhance the effectiveness of hormone therapy like letrozole, leading to better outcomes in terms of progression-free survival compared to hormone therapy alone.678910
What data supports the effectiveness of the drugs used in the Hormone Therapy +/− Everolimus for Breast Cancer trial?
Research shows that letrozole, an aromatase inhibitor, is more effective than tamoxifen in improving disease-free survival and reducing breast cancer recurrence in postmenopausal women with hormone-sensitive breast cancer. Additionally, studies indicate that aromatase inhibitors like anastrozole, letrozole, and exemestane have better efficacy and tolerability compared to tamoxifen.4581112
Who Is on the Research Team?
Mariana Chavez-MacGregor, MD, MSc
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for high-risk breast cancer patients who've had surgery with negative margins and appropriate axillary staging. They must have ER or PR positive status, not be on trastuzumab, have controlled diabetes if applicable, no uncontrolled lung disease, able to take oral meds, not pregnant/nursing, completed standard chemo prior to randomization, performance status 0-2 by Zubrod criteria. No recent heart attacks or severe cardiac disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive an approved endocrine therapy for 2-5 years and either a placebo or everolimus for 1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Anastrozole
- Everolimus
- Exemestane
- Goserelin Acetate
- Letrozole
- Leuprolide Acetate
- Tamoxifen Citrate
Anastrozole is already approved in European Union, United States, Canada, Japan for the following indications:
- Breast cancer
- Early 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 or hormone receptor unknown locally advanced or metastatic breast cancer
- Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
- Treatment of postmenopausal women with hormone receptor-positive advanced breast cancer
- Breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Southwest Oncology Group
Lead Sponsor
SWOG Cancer Research Network
Lead Sponsor
National Cancer Institute (NCI)
Collaborator