Description:

Confirmation of Registration Form (Form 24-A) Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG-2402 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B0EA065B-0F5E-629F-E034-0003BA12F5E7

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https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B0EA065B-0F5E-629F-E034-0003BA12F5E7

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  1. 8/27/12
  2. 1/9/15
Uploaded on:

January 9, 2015

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Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00659373 Registration - Confirmation of Registration Form (Form 24-A) - 2072688v3.0

Details

CONFIRMATION OF REGISTRATIN FORM (Form 24-A)

  1. StudyEvent: Confirmation of Registration Form (Form 24-A)
    1. CONFIRMATION OF REGISTRATIN FORM (Form 24-A)
Ccrr Module For Confirmation Of Registration Form (form 24-a)
Eligibility Checklist
Randomized within 12 weeks after definitive surgery.
Premenopausal [estrodiol (E2) in premenopausal range] following surgery.
Randomized after completing chemotherapy and within 6 months of the final dose of chemotherapy as soon as premenopausal status is confirmed.
Premenopausal [estrodiol (E2) in premenopausal range] between 2 weeks and 6 months after completing chemotherapy.
Histologically proven, resected breast cancer.
Estrogen and/or progesterone receptor POSITIVE tumor which is defined as . Or = 10% of the tumor cells positive by immunohistochemical evaluation.
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. Patients who received neoadjuvant therapy must have had op
Total mastectomy (with or without radiotherapy planned) 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.
Either axillary lymph node dissection OR negative axillary sentinel node biopsy and workup. Patients with H&E positive axillary nodes require axillary dissection, except for patients with microscopically positive (pN1 mi: micrometastasis < 2mm) axillary
Eligibility Checklist
No locally advanced inoperable or inflammatory breast cancer.
No bilateral invasive breast cancer.
Final margins negative (referring to DCIS and invasive cancer, not LCIS.)
No clinically detectable residual axillary disease.
No supraclavicular node involvement or evidence of distant metastatic disease.
No history of prior ipsilateral or contralateral invasive breast cancer.
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.
No non-malignant systemic diseases that would prevent prolonged follow-up.
(except if randomized to OFS).
No history of noncompliance to medical regimens and not considered potentially unreliable.
Not pregnant or lactating at the time of randomization and does not desire pregnancy within five years.
Not planning to use additional hormonal treatment apart from randomized treatment during the next five years, including all types of hormonal contraception.
No more than six months of endocrine treatment (adjuvant and neoadjuvant) after breast cancer diagnosis.
No Tamoxifen, other SERM (e.g. Raloxifene), or HRT within 1 year prior to diagnosis.
Has not taken GnRH analogue for breast cancer treatment.
No psychiatric, addictive or other disorder which compromises ability to give informed consent for participation in study.
Accessible for follow-up.
Informed and agreed to data and tissue material transfer and handling, in accordance with national data protection guidelines.
Are all the answers to the Eligibility Checklist YES? (must be yes to randomize)
Has Informed Consent Form been signed and dated by the patient and Investigator? (must be yes to randomize)
Is protocol-required pathology material available
Have baseline QL Core and module forms been completed?
Stratification Factors
Prior adjuvant and/or neoadjuvant chemotherapy
Tumor Laterality
Right Breast/Side
Left Breast/Side
Intended method of ovarian function suppression if patient is randomized to OFS:
Most Extensive Primary Surgery (Left breast/side)
Most Extensive Primary Surgery (Left breast/side)
Is adjuvant breast/chest wall radiotherapy planned, ongoing or completed?
Assigned Treatment Arm
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