Endocrine Therapy Without Radiotherapy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will collect rates of local/regional recurrence in select patients who do not receive radiation treatment after lumpectomy surgery. These women must be postmenopausal; have hormone receptor-positive, Her2-negative tumors; have Oncotype-DX RS less than or equal to 18; and plan to receive endocrine therapy. In this way, this study seeks to collect prospective data supporting the idea that this is a population at sufficiently low risk of local/regional recurrence that omission of adjuvant radiation might be a reasonable option.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, you must be willing to take endocrine therapy for at least 5 years, which may affect your current medication plan.
Is endocrine therapy safe for humans?
How is endocrine therapy different from other breast cancer treatments?
Endocrine therapy for breast cancer is unique because it targets hormone receptors to block estrogen, which fuels cancer growth, using drugs like tamoxifen and aromatase inhibitors. Unlike chemotherapy, it is often better tolerated with fewer side effects and can be used in various stages of the disease, especially effective in early stages.16789
What evidence supports the effectiveness of endocrine therapy as a treatment for breast cancer?
Endocrine therapy is effective in treating hormone receptor positive metastatic breast cancer, showing similar survival rates to chemotherapy and being well-tolerated. It has been a standard treatment for many years, with drugs like tamoxifen and aromatase inhibitors providing significant benefits in both advanced and early breast cancer settings.68101112
Who Is on the Research Team?
Reshma Jagsi, M.D., Ph.D.
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
Postmenopausal women with hormone receptor-positive, Her2-negative stage 1 breast cancer who've had a lumpectomy can join this study. They must have an Oncotype-DX score ≤18 and agree to take endocrine therapy for at least 5 years. Women with prior breast cancer, known genetic predispositions like BRCA mutations, or evidence of more widespread disease 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 endocrine therapy alone without radiotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Endocrine Therapy
Endocrine Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer Center
Lead Sponsor
Harvard University
Collaborator
Yale University
Collaborator
Rutgers Cancer Institute of New Jersey
Collaborator
East Carolina University
Collaborator
Johns Hopkins University
Collaborator
Medical College of Wisconsin
Collaborator
Stanford University
Collaborator
University of Texas Southwestern Medical Center
Collaborator
Loyola University
Collaborator