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.
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.
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.
Single group
FACT-B
BehavioralThe FACT-B (Version 4) is a 37-item measure that contains the four general subscales along with the Breast Cancer-Specific subscale that assesses symptoms/concerns of particular relevance to breast cancer (e.g., body image, arm swelling and tenderness).
Goserelin
DrugAnastrozole
DrugExemestane
DrugFulvestrant
DrugTamoxifen
DrugArchived tissue collection
Other interventionResponse rate
* Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) \[Eur J Ca 45:228-247, 2009\]. * In each RECIST response category Oncotype DX scores will be summarized with mean, standard deviation, minimum, 1st, 2nd (median) and 3rd quartiles, and maximum values. OncotypeDx scores range from 0 to 100, with scores \<18 indicating low risk.
Breast cancer-specific survival
Breast cancer-specific survival
Breast cancer-specific survival
Rate of overall survival
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Washington University School of Medicine
Lead sponsor
Genomic Health®, Inc.
Collaborator
