Description:

FORM 1 - ELIGIBILITY CHECK LIST AND INITIAL EVALUATION MA.27 Quality Of Life Companion Study For JMA27 (NCIC-MA.27): A Randomized Phase III Trial Of Exemestane Versus Anastrozole With Or Without Celecoxib In Postmenopausal Women With Receptor Positive Primary Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ABF84340-BD14-67AC-E034-0003BA12F5E7

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https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ABF84340-BD14-67AC-E034-0003BA12F5E7

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  1. 8/26/12
  2. 12/12/14
  3. 4/13/21
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April 13, 2021

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Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00090974 On-Study - FORM 1 - ELIGIBILITY CHECK LIST AND INITIAL EVALUATION MA.27 - 2067101v3.0

A RANDOMIZED PHASE III TRIAL OF EXEMESTANE VERSUS ANASTROZOLE WITH OR WITHOUT CELECOXIB IN POSTMENOPAUSAL WOMEN WITH RECEPTOR POSITIVE PRIMARY BREAST CANCER-MA.27

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
Patient has completely resected and histologically confirmed invasive breast carcinoma.
Pathological TNM classification is (M stage)
Pathological TNM classification is (M stage)
Pathological TNM classification is (M stage)
Primary tumour is receptor positive i.e. ER and/or PgR positive (defined as receptor content of >= 10fmol/mg protein or receptor positive by ERICA or PgRICA).
If patient has bilateral breast cancer, both were diagnosed at the same time and at least one of the bilateral cancers is receptor positive (as defined above)
Patient is post-menopausal according to one of these three criteria
Radiologic investigations have been completed within 4 weeks prior to surgical resection of primary tumour and are negative for metastases
Radiologic investigations have been completed (To specify investigations)
bone scan (required only if alkaline phosphatase is >= 2 x UNL and/or there are symptoms of metastatic disease a confirmatory x-ray or other imaging study such as CT or MRI is required if the results from the bone scan are questionable)
abdominal ultrasound or CT abdomen (required only if the AST/ALT or alkaline phosphatase is > 2 x UNL unless the elevation is in the bone fraction)
Patient has had a bilateral mammogram within 10 months prior to randomization.
If patient has received prior adjuvant chemotherapy, no less than 3 weeks and no more than 3 months have elapsed since completion of chemotherapy (planned radiotherapy may be given concurrently with protocol therapy).
Patient has a minimum life expectancy of 5 years.
Performance Status (ECOG) is (circle one see Appendix II)
Patient is able to swallow the study medication and have adequate unassisted oral intake to maintain a reasonable state of nutrition.
Patient is able and willing to comply with scheduled study visits at the participating centre.
Informed consent has been signed and dated by patient.
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.
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.
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.
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])
No prior treatment with a recognized aromatase inhibitor.
No known or incompletely treated peptic ulcer disease.
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)
No history of asthma, urticaria or allergic type reactions after taking aspirin or other NSAIDs.
No co-existing medical or psychiatric condition that is likely to interfere with study procedures or results.
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.
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
Prior adjuvant chemotherapy?
Prior raloxifene therapy?
Prior adjuvant RT?
Is concurrent RT planned for this patient?
Disease History... Continued; Bone Fractures
Has the patient experienced a bone fracture in the last 10 years?
Bone Fracture Site, Spinal (Check)
Bone Fracture Site, Wrist (Check)
Bone Fracture Site, Pelvis (Check)
Bone Fracture Site, Hip (Check)
Bone Fracture Site, Femur (Check)
Bone Fracture Site, Tibia (Check)
Bone Fracture Site, Ankle (Check)
Bone Fracture Site, Other (specify) (Check)
Osteoporosis
Has the patient had a diagnosis of osteoporosis?
Cardiovascular Morbidity
Has the patient suffered cardiovascular disease?
Cardiovascular Event
Myocardial infarction
Stroke/transient ischemic attack (TIA)
On-going angina (no surgical intervention)
Angina requiring percutaneous transluminal coronary angioplasty (PTCA)
Thromboembolic event
Other (specify), 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
Is the patient taking any medication?
Agent Name (generic or trade name)
Continuing
Other Major Medical Problems
Have there been any major medical problems?
Comments
Investigator Signature

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