Breast Cancer NCT00066703 Registration - Confirmation of Registration Form (Form 25-A) - 2168101v3.0 Ccrr Module For Registration Form (form 25-a) Premenopausal Yes
No
Randomized within 12 weeks after definite surgery prior to commencing any adjuvant systemic therapy Yes
No
Histologically proven, resected breast cancer Yes
No
Estrogen and/or progesterone receptor Postitive tumor which is defined as > or = 10% of tumor cells positive by immunohistochemical evaluation Yes
No
The tumor must be confined to the breast and axillary nodes without detected metastases elsewhere, with the exception of tumor detected in internal mammary chain nodes by sentinel node procedure. Yes
No
Total mastectomy OR breast-conserving procedure with radiotherapy to the conserved breast planned. Margins must be clear of invasive cancer and DCIS. Documented clear margins of resection in pathology report. Yes
No
Either axillary lymph node dissection OR negative axillary node biopsy and workup. Yes
No
No locally advanced inoperable or inflammatory breast cancer Yes
No
no bilateral invasive breast cancer. Yes
No
Final margins negative Yes
No
No clinically detectable residual axillary disease. Yes
No
No supraclavicular node invovlement, no enlarged internal mammary nodes, no evidence of distant metastatic disease. Yes
No
No history of prior ipsilateral or contralateral invasive breast cancer. Yes
No
No previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix or bladder, or contra- or ipsilateral in situ breast carcinoma. Yes
No
No non-malignant systemic diseases that would prevent prolonged follow-up. Yes
No
No prior bilateral oophorectomy or ovarian reduction. Yes
No
No history of noncompliance to medical regimens and no considered potentially unreliable. Yes
No
Not pregnant or lactating at the time of randomization and does not desire pregnancy within five years. Yes
No
Not planning to use additional hormonal treatment apart from randomized treatment during the next five years, including all types of hormonal contraception. Yes
No
No endocrine therapy after breast cancer diagnosis. Yes
No
No Tamoxifen, other SERM, or HRT within 1 year prior to diagnosis. Prior oral contraceptives are allowed. Yes
No
No neoadjuvant or adjuvant chemotherapy. Yes
No
No phychiatric, addictive, or other disorder which compromises ability to give informed consent for participation in study. Yes
No
Accessible for follow-up. Yes
No
Informed and agreed to data and tissue material transfer and handling, in accordance with national data protection guidelines. Yes
No
Are all answers to the Eligibility Checklist YES? Yes
No
Has informed consent form been signed and dated by the patient and investigator? Yes
No
Is protocol-required pathology material available Have baseline QL Core and module forms been completed? Was the patient randomized to Trial 26-02 Yes
No
Will adjuvant chemotherapy be given? Yes
No
Tumor Laterality Right Breast/Side Left Breast/Side Most Extensive Primary Surgery (Right breast/side) Most Extensive Primary Surgery (Right breast/side) Is adjuvant breast/chest wall radiotherapy planned, ongoing or completed? Yes
No
Assigned Treatment Arm 
