Confirmation of Registration Form (Form 26-A) A Phase III Trial Evaluating the Role of Chemotherapy as Adjuvant Therapy for Premenopausal Women With Endocrine Responsive Breast Cancer Who Receive Endocrine Therapy Source Form: NCI FormBuilder:


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  2. 1/9/15
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January 9, 2015

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Breast Cancer NCT00066807 Registration - Confirmation of Registration Form (Form 26-A) - 2167967v3.0

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  1. StudyEvent: Confirmation of Registration Form (Form 26-A)
    1. No Instruction available.
Ccrr Module For Registration Form (form 26 A)
Suitable for adding chemotherapy to the adjuvant systemic therapy
Randomized within 12 weeks after definite surgery
To be selected by subsequent randomization to the TEXT trial
Histologically proven, resected breast cancer
Estrogen and/or progesterone receptor Postitive tumor which is defined as > or = 10% of 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.
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.
Either axillary lymph node dissection OR negative axillary node biopsy and workup.
No locally advanced inoperable or inflammatory breast cancer
no bilateral invasive breast cancer.
Final margins negative
No clinically detectable residual axillary disease.
No supraclavicular node invovlement, no enlarged internal mammary nodes, no 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.
No prior bilateral oophorectomy or ovarian reduction.
No history of noncompliance to medical regimens and no 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 endocrine therapy after breast cancer diagnosis.
No Tamoxifen, other SERM, or HRT within 1 year prior to diagnosis. Prior oral contraceptives are allowed.
Has not received neoadjuvant or adjuvant chemotherapy.
No phychiatric, 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 answers to the Eligibility Checklist YES?
Has informed consent form been signed and dated by the patient and investigator?
Is protocol-required pathology material available
Have baseline QL Core and module forms been completed?
Tumor Laterality
Right Breast/Side
Left Breast/Side
Intended method of ovarian function suppression
Intended chemotherapy
Intended endocrine agent
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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