Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 70 - Any |
| Updated: | 3/16/2019 |
| Start Date: | January 17, 2017 |
| End Date: | July 31, 2024 |
| Contact: | Rebecca L Aft, M.D., Ph.D. |
| Email: | aftr@wustl.edu |
| Phone: | 314-747-0063 |
Endocrine Treatment Alone as Primary Treatment for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score
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.
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.
Inclusion Criteria:
- Newly diagnosed histologically or cytologically confirmed operable invasive breast
cancer defined as cT1 or T2, N0-1, and M0.
- Disease must be ER+ and HER2-.
- Ki67 score/proliferative index ≤ 30% or low to intermediate mitotic index
- Measurable disease defined as lesions that can be accurately measured in at least one
dimension (longest diameter to be recorded) by ultrasound or mammogram.
- 70 years of age or older.
- ECOG performance status ≤ 3
- Able to understand and willing to sign an IRB approved written informed consent
document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
- Prior surgery for this cancer
- A history of other malignancy ≤ 5 years previous which would preclude endocrine
treatment of their cancer.
- Currently receiving any other investigational agents.
- A history of allergic reactions attributed to compounds of similar chemical or
biologic composition to any of the agents used in the study.
- Uncontrolled intercurrent illness as determined by their treating physician which
would limit compliance with study requirements.
- Known HIV-positivity on combination antiretroviral therapy because of the potential
for pharmacokinetic interactions with endocrine therapies. Appropriate studies will be
undertaken in patients receiving combination antiretroviral therapy when indicated.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Rebecca L Aft, M.D., Ph.D.
Phone: 314-747-0063
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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