Breast Cancer NCT00090974 On-Study - FORM 1 - ELIGIBILITY CHECK LIST AND INITIAL EVALUATION MA.27 - 2067101v3.0 Patient Information Patient Gender Patient Race (check all that apply Patient is encouraged to self designate: Race Categories and Definitions definitions given with each value) Patient Ethnicity (check one only Ethnicity Categories and Definitions definition given with value value) Payment method (check one USA only) Eligibility Checklist Stratification Axillary Nodes Prior adjuvant chemotherapy? Chronic low dose prophylactic aspirin use Eligibility Checklist Continued Required hematologic investigations done within 4 weeks prior to randomization and are within the required parameters for eligibility. Yes
No
Required biochemistry investigations done within 4 weeks prior to randomization and are within the required parameters for eligibility unless imaging examinations have ruled out metastatic disease. Yes
No
Patient has no history of other malignancies except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix or other solid tumours curatively treated with no evidence of disease for >= 5 years from randomization. Yes
No
Patient is not receiving concurrent hormonal therapy with estrogens, progesterones, androgens or any selective estrogen receptor modulator (SERM). (previous use of Raloxifene, specifically, is permitted provided this is discontinued at least 3 weeks prior to randomization; intermittent use, i.e. maximum of 2 x per week, of vaginal estrogens is permitted on protocol if other local [trunc. see form]) Yes
No
No prior treatment with a recognized aromatase inhibitor. Yes
No
No known or incompletely treated peptic ulcer disease. Yes
No
Patient is not receiving concurrent NSAID therapy or Cox-2 Inhibitor therapy e.g. Vioxx. (chronic low dose, i.e. <= 81 mg/day, prophylactic aspirin will be allowed) Yes
No
No history of asthma, urticaria or allergic type reactions after taking aspirin or other NSAIDs. Yes
No
No co-existing medical or psychiatric condition that is likely to interfere with study procedures or results. Yes
No
If patient has participated in another trial for breast cancer (e.g. adjuvant chemotherapeutic trial), permission has been obtained, from the sponsors of that trial for the patients to participate in MA.27. Yes
No
Certificate Of Eligibility In the opinion of the investigator is the patient eligible? History And Physical Exam Performance Status (check one see protocol Appendix II) Patient is post-menopausal according to one of these three criteria Investigations Imaging Site Method of Evaluation Investigations Continued Baseline Hematology/biochemistry Values Lab Unit of Measure (circle unit used) Lab Unit of Measure (circle unit used) Lab Unit of Measure (circle unit used) Lab Unit of Measure (circle unit used) Lab Unit of Measure (circle unit used) Lab Unit of Measure (circle unit used) Lab Unit of Measure (circle unit used) Lab Unit of Measure (circle unit used) Lab Unit of Measure (circle unit used) Lab Unit of Measure (circle unit used) Disease History/prior Treatment/adverse Events Most extensive primary surgery Was axillary dissection performed? Disease History... Continued Tumour Laterality (check one) Receptor Status, ER (If measure in fmols/mg, cytosl protein >= 10 is postive. If other measures are used, apply institutional standards; borderline results should be reported as positive) Receptor Status, PgR (If measure in fmols/mg, cytosl protein >= 10 is postive. If other measures are used, apply institutional standards; borderline results should be reported as positive) T Stage, Pathologic (check one) N Stage, Pathologic (check one) M Stage, Pathologic (check one) Prior Treatment For Cancer Disease History... Continued; Bone Fractures Osteoporosis Cardiovascular Morbidity Has the patient suffered cardiovascular disease? Cardiovascular Event Baseline Symptoms - Toxicity Status CTC Adverse Event Term (Code/grade according to NCI Common Toxicity Criteria, Version 2.0) CTC Adverse Event Category (Code/grade according to NCI Common Toxicity Criteria, Version 2.0) Concomitant Medications Other Major Medical Problems Comments Investigator Signature 
