Postmenopausal state | Secondary malignant neoplasm of female breast | Menstruation absent Duration | Bilateral salpingectomy with oophorectomy | Hysterectomy | Hysterectomy Absent | Age | Ovariectomy | Ovariectomy Absent | Serum follicle stimulating hormone measurement Consistent with Postmenopausal state
Item
post-menopausal women with metastatic carcinoma of the breast; post-menopausal, as defined by at least one of the following: at least 12 months without spontaneous menstrual bleeding, history of bilateral salpingo-oophorectomy with or without hysterectomy, age > 55 with hysterectomy with or without oophorectomy, serum fsh in post-menopausal range within 4 weeks of registration
boolean
C0232970 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
C0497456 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C0195495 (UMLS CUI [4])
C0020699 (UMLS CUI [5])
C0020699 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0001779 (UMLS CUI [7])
C0029936 (UMLS CUI [8])
C0029936 (UMLS CUI [9,1])
C0332197 (UMLS CUI [9,2])
C0455276 (UMLS CUI [10,1])
C0332290 (UMLS CUI [10,2])
C0232970 (UMLS CUI [10,3])
Estrogen receptor positive Immunohistochemistry | Progesterone receptor positive Immunohistochemistry
Item
positive for estrogen receptor (er) or progesterone receptor (pgr) with positivity defined as immunohistochemical staining in >= 10% of cells
boolean
C0279754 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0279759 (UMLS CUI [2,1])
C0021044 (UMLS CUI [2,2])
Measurable Disease | Evaluable Disease Non-Measurable | Evaluation Completed | Chest CT | CT of abdomen | CT of Pelvis | Radioisotope scan of bone
Item
either measurable disease by recist or non-measurable evaluable disease; tests to evaluate disease (measurable and non-measurable) must be completed within 28 days prior to registration; these will include a ct scan of the chest/abdomen/pelvis and a bone scan; patients with effusions or ascites as the only sites of disease are ineligible
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2,1])
C1518373 (UMLS CUI [2,2])
C1261322 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0202823 (UMLS CUI [4])
C0412620 (UMLS CUI [5])
C0412628 (UMLS CUI [6])
C0203668 (UMLS CUI [7])
Zubrod Performance Status
Item
performance status of 0-2 by zubrod criteria
boolean
C3714786 (UMLS CUI [1])
CA 15-3 measurement | Cancer Antigen 27-29 Measurement
Item
patients must have a baseline ca15-3 or ca 27.29 measurement for future comparison, but any baseline value is acceptable
boolean
C0201547 (UMLS CUI [1])
C2919221 (UMLS CUI [2])
Aromatase Inhibitors Neoplasm Metastasis | Aromatase Inhibitors Adjuvant therapy | Neoplasm Metastasis Development | Tamoxifen | fulvestrant | Estradiol Absent Secondary malignant neoplasm of female breast
Item
patients must have had prior aromatase inhibitor (ai) therapy in the metastatic setting (oneany number of prior ai is allowed, this may have been any of the ai's), or have developed metastatic disease on adjuvant ai therapy; prior treatment with tamoxifen and/or fulvestrant is also allowed; patients must not have been previously treated with estradiol for metastatic breast cancer
boolean
C0593802 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0593802 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0243107 (UMLS CUI [3,2])
C0039286 (UMLS CUI [4])
C0935916 (UMLS CUI [5])
C0014912 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0346993 (UMLS CUI [6,3])
Able to swallow Oral medication
Item
patients must be able to take oral medications
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Informed Consent
Item
patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines
boolean
C0021430 (UMLS CUI [1])
Serum Specimen Submission | Circulating Neoplastic Cells Blood specimen Submission
Item
patients must consent to the serum and ctc blood specimen submissions
boolean
C1550100 (UMLS CUI [1,1])
C1515022 (UMLS CUI [1,2])
C0027625 (UMLS CUI [2,1])
C0178913 (UMLS CUI [2,2])
C1515022 (UMLS CUI [2,3])
Chemotherapy Malignant Neoplasms | Hormone Therapy Malignant Neoplasms | Hormone replacement therapy Malignant Neoplasms | Therapeutic radiology procedure Malignant Neoplasms | Antibody therapy Malignant Neoplasms | Exception Trastuzumab
Item
planning to receive concomitant chemotherapy, hormone therapy (including hormone replacement therapy), radiation therapy, or antibody therapy for malignancy while receiving protocol treatment, with the single exception of trastuzumab; concomitant trastuzumab will be allowed for her-2 positive patients who were previously on trastuzumab; patients who have had previous radiotherapy must complete treatment within 4 weeks of registration, and have recovered from acute toxicity from radiation; patients with prior cytotoxic chemotherapy for metastatic disease will not be eligible
boolean
C0392920 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0282402 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
C0281176 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0728747 (UMLS CUI [6,2])
Estradiol allergy | Intolerance to Estradiol | Hypersensitivity Aromatase Inhibitors | Intolerance to Aromatase Inhibitors | Aspirin allergy | Intolerance to Aspirin | Gastrointestinal Hemorrhage Due to Aspirin
Item
known hypersensitivity or intolerance to estradiol, aromatase inhibitors, or aspirin; patients must not have a history of aspirin-induced gi bleeding within the past 3 years
boolean
C0571688 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C0014912 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0593802 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0593802 (UMLS CUI [4,2])
C0004058 (UMLS CUI [5])
C1744706 (UMLS CUI [6,1])
C0004057 (UMLS CUI [6,2])
C0017181 (UMLS CUI [7,1])
C0678226 (UMLS CUI [7,2])
C0004057 (UMLS CUI [7,3])
Metastatic malignant neoplasm to brain Untreated | CNS metastases Untreated
Item
known untreated brain or cns metastases due to the risk of bleeding on aspirin during estradiol
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Deep Vein Thrombosis | Pulmonary Embolism | Clot Requirement Anticoagulation Therapy | Thrombophilia, hereditary
Item
history of deep vein thrombosis, pulmonary embolism, or other clot requiring anticoagulation; patients must not have a known inherited hypercoagulable disorder
boolean
C0149871 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
C0302148 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0003281 (UMLS CUI [3,3])
C2584620 (UMLS CUI [4])
CONGESTIVE HEART FAILURE DECOMPENSATED Limiting Treatment Compliance | Unstable Angina Limiting Treatment Compliance | Mental disorders Uncontrolled Limiting Treatment Compliance
Item
history of decompensated congestive heart failure, unstable angina, or uncontrolled psychiatric illness which would limit compliance with the protocol treatment
boolean
C0742746 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C4319828 (UMLS CUI [1,3])
C0002965 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C4319828 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C4319828 (UMLS CUI [3,4])
Malignant Neoplasm Previous | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Malignant Neoplasm TNM clinical staging Treated | Exception Malignant Neoplasm In complete remission | Exception Disease Free of Duration
Item
prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage i or ii cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C3258246 (UMLS CUI [5,3])
C1522326 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0006826 (UMLS CUI [6,2])
C0677874 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0012634 (UMLS CUI [7,2])
C0332296 (UMLS CUI [7,3])
C0449238 (UMLS CUI [7,4])