Multiple neoadjuvant endocrine trials demonstrate that women with good prognosis tumors can
be identified. A new standard of care needs to be defined for elderly women with good
prognosis 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 75 or older with ER+ breast cancer and low recurrence scores.
- Newly diagnosed histologically or cytologically confirmed operable invasive breast
cancer defined as cT1 or T2, N0-1, and M0.
- Disease must be ER+ (Allred score 5) and HER2-.
- Measurable disease defined as lesions that can be accurately measured in at least one
dimension (longest diameter to be recorded) by ultrasound or mammogram.
- 75 years of age or older.
- ECOG performance status 2
- Able to understand and willing to sign an IRB approved written informed consent
document (or that of legally authorized representative, if applicable).
- Prior chemotherapy and/or hormone therapy for 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
Minimum Eligible Age: 75 Years
Maximum Eligible Age: N/A
Eligible Gender: Female