Hormone Therapy +/− Everolimus for Breast Cancer
(e3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of hormone therapy in treating breast cancer, either alone or combined with everolimus, a targeted therapy. Hormone therapy aims to reduce estrogen levels, which can promote cancer growth, while everolimus may help stop tumor growth by blocking certain enzymes. The trial targets patients with hormone-receptor positive, HER2 negative breast cancer who have completed chemotherapy and surgery and are considered high-risk for cancer recurrence. Participants will receive either hormone therapy alone or with everolimus to determine which approach is more effective. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to contribute to potentially groundbreaking treatment advancements.
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 there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the hormone therapies used in the trial, such as tamoxifen, anastrozole, and letrozole, are generally well-tolerated. These treatments have been used for many years to treat breast cancer, with common side effects including hot flashes and fatigue.
For everolimus, studies indicate it can also be effective, but it may cause a broader range of side effects. Some patients have experienced mouth sores or fatigue. Serious issues, like kidney problems, have been rare but have occurred in some cases. Despite these concerns, everolimus has demonstrated benefits in treating certain cancers, suggesting that its risks can be managed with proper care.
Overall, while hormone therapies usually have mild side effects, adding everolimus might increase the risks. However, the potential benefits in fighting cancer could make it worthwhile for some patients. It is important to consult a doctor to understand what these results mean for individual health.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the treatment with everolimus for breast cancer because it targets a different mechanism compared to standard hormone therapies like tamoxifen or aromatase inhibitors. While most treatments focus on blocking hormone receptors or reducing estrogen production, everolimus works by inhibiting the mTOR pathway, which is involved in cell growth and proliferation. This dual approach could potentially enhance the effectiveness of existing hormone therapies and provide a new option for patients who have not responded well to standard treatments. The combination of hormone therapy with everolimus aims to delay disease progression more effectively than hormone therapy alone, offering hope for improved outcomes.
What evidence suggests that this trial's treatments could be effective for breast cancer?
Research has shown that adding everolimus to hormone therapy can greatly improve outcomes for breast cancer patients. In this trial, participants in one arm will receive an approved endocrine therapy regimen along with everolimus. Studies have found that combining everolimus with hormone treatments like letrozole significantly extends the time before cancer worsens. Specifically, it more than doubles the time without tumor growth compared to hormone therapy alone and reduces the risk of cancer progression by 57%. Everolimus blocks certain enzymes in cancer cells, helping to stop their growth. This makes it a promising addition to hormone therapy for treating breast cancer.15678
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