ID

10019

Descrição

NSABP PROTOCOL B-35: REGISTRATION FORM Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy NCT00053898 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A053033F-8CE7-05B1-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A053033F-8CE7-05B1-E034-080020C9C0E0

Palavras-chave

  1. 26/08/2012 26/08/2012 -
  2. 18/03/2015 18/03/2015 - Martin Dugas
Transferido a

18 de março de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00053898 Registration - NSABP PROTOCOL B-35: REGISTRATION FORM - 2033723v3.0

Form A (04-30-2002) Prior to randomization, fax Form A and signed consent to 412-383-2065.

Header
Month Day Year
Race Categories
Ethnic Categories
Method of Payment
Country of Residence (if not USA)
Patient data
Performance Status
kg
Eligibility Checklist
In the opinion of the investigator, is the patient eligible?
Verification of Postmenopausal Status (Select the item that best describes the patient.)
Month Day Year
Surgical Treatment And Pathology
Did the patient undergo lumpectomy?
Was the patient diagnosed with invasive or microinvasive breast cancer?
Did the patient have ductal carcinoma in situ (DCIS) on histologic examination?
Are the final margins of the resected specimen histologically free of DCIS?
Were there any clinically or mammographically suspicious masses or clusters of calcification?
If item 5 is yes, were these suspicious masses or clusters of calcification biopsied?
If item 5a is yes, are the margins histologically free of DCIS?
Are there suspicious palpable nodes in the ipsilateral or contralateral axilla? ([If item 6 is yes, attach pathologic documentation that these are not involved with tumor])
Are there palpable supraclavicular or infraclavicular nodes? ([If item 7 is yes, attach pathologic documentation that these are not involved with tumor])
Is there a bilateral malignancy or a mass or mammographic abnormality in the opposite breast that is suspicious for malignancy? ([If item 8 is yes, attach pathologic documentation that this is not malignant])
Did the patient have one or more ipsilateral axillary nodes or intramammary nodes that were positive for tumor on histologic examination?
Did the patient undergo mastectomy?
Other Treatment
Has systemic or radiation therapy been given for the current DCIS?
Has the patient previously taken, or is the patient currently taking, aromatase inhibitors or tamoxifen for treatment or prevention of any disease?
Is the patient currently taking raloxifene (Evista [R])or other selective estrogen receptor modulators (SERMs)? ([Circle "no" if this therapy is discontinued prior to randomization.])
Has the patient been taking any sex hormonal therapy, e.g. estrogen or progesterone replacement therapy, oral contraceptives, androgens, etc.? ([See Protocol, Section 5.2.11])
If item 14 is yes, was this therapy discontinued prior to randomization?
Contraindications
Has the patient ever been diagnosed with a non-breast malignancy?
If item 16 is yes, has the patient been disease-free for at least 5 years?
If item 16a is no, was the diagnosis squamous or basal cell carcinoma of the skin which was effectively treated, carcinoma in situ of the cervix that has been treated by surgery alone, or lobular carcinoma in situ (LCIS) of the ipsilateral or contralateral breast
Does the patient have a prior history of documented cerebral vascular accident or documented transient ischemic attack?
Does the patient have a nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude her being subjected to protocol therapy or would prevent prolonged follow-up?
Does the patient have a psychiatric or addictive disorder which would preclude obtaining informed consent?
Does the patient have a prior history of invasive breast cancer or DCIS?
Does the patient have uncontrolled hypertension?
Does the patient have uncontrolled diabetes?
Does the patient have atrial fibrillation, not controlled by medication?
Pre-entry Studies
Has the patient had a history and physical in the last 6 months?
Has the patient had a bilateral mammogram within the past 12 months?
Has the patient had a hysterectomy?
If item 26 is no, has the patient had a pelvic exam within the past 12 months?

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