Actively Recruiting
Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score
Led by Washington University School of Medicine · Updated on 2025-07-28
50
Participants Needed
1
Research Sites
810 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
G
Genomic Health®, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Multiple neoadjuvant endocrine trials demonstrate that women with good prognosis tumors can be identified. These trials have also demonstrated that there are not adverse effects on overall outcome if women are treated with neoadjuvant endocrine therapy for several months prior to definitive treatment. A new standard of care needs to be defined for elderly women with good prognosis estrogen receptor (ER)+ tumors, since these women may benefit from endocrine therapy alone to treat their cancer without compromising local and distant control. The investigators hypothesize that endocrine therapy alone provides adequate local and systemic control of breast cancer in a subpopulation of women 70 or older with ER+ breast cancer and low Ki67 scores.
CONDITIONS
Official Title
Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed operable invasive breast cancer defined as cT1 or T2, N0-1, and M0
- Estrogen receptor positive and HER2 negative disease
- Ki67 score or proliferative index 30% or less, or low to intermediate mitotic index
- Measurable disease by ultrasound or mammogram
- Age 70 years or older
- ECOG performance status of 3 or less
- Able and willing to provide informed consent
You will not qualify if you...
- Prior surgery for the breast cancer
- History of other cancers within 5 years that would prevent endocrine treatment
- Currently receiving other investigational treatments
- History of allergic reactions to similar study agents
- Uncontrolled illnesses limiting study compliance
- Known HIV positive on combination antiretroviral therapy due to drug interaction risks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
R
Rebecca L Aft, M.D., Ph.D.
CONTACT
T
Tracie Guthrie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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