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10019

Description

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

Keywords

Clinical Trial

Registration

Breast Neoplasms

Versions (2)

8/26/12 8/26/12 -
3/18/15 3/18/15 - Martin Dugas

Uploaded on

March 18, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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

English 1

English

Details

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

1 forms

StudyEvent: NSABP PROTOCOL B-35: REGISTRATION FORM
1. Form A (04-30-2002) Prior to randomization, fax Form A and signed consent to 412-383-2065.

Header

Patient Study ID

Patient Medical Record Number

Institution Name

Institution Number

Affiliate Name

Physician of Record (physician to whom study drug will be sent; must have a valid FDA Number)

Date Informed Consent Signed

Month Day Year

Projected Start Date of Treatment (Study Drug Month Day Year)

Person Completing Form Last Name

Person Completing Form First Name

Person Completing Form Phone

Person Completing Form Fax

Patient Name (Last, First, MI Last First MI)

Patient's Date of Birth (Month Day Year)

Patient's Social Security Number (USA only)

Race Categories

White (White)

Black or African American (Black or African American)

Black (Black)

Native Hawaiian Or Other Pacific Islander (Native Hawaiian or Other Pacific Islander)

3 more items in the detailed view.

Ethnic Categories

Hispanic Or Latino (Hispanic or Latino)

Hispanic (Hispanic)

Non-hispanic (Non-Hispanic)

Unknown (Unknown)

Method of Payment

Private Insurance (Private Insurance)

Medicare (Medicare)

Medicare & Private (Medicare & Private)

Medicaid (Medicaid)

8 more items in the detailed view.

Country of Residence (if not USA)

Canada (Canada)

Mexico (Mexico)

Puerto Rico (Puerto Rico)

Other (Other)

Other

Patient's zip code (USA)

Patient data

Performance Status

Fully active, able to carry on all pre-disease performance without restriction (Karnofsky 90-100) (0)

Restricted in physically strenous activity but ambulatory (K 70-80) (1)

Ambulatory and capable of all selfcare but unable to carry out any work activities (K 50-60) (2)

Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours (K 30-40) (3)

Completely disabled (K 10-20) (4)

Age at Registration

Patient Height (cm)

Patient Weight

WBC

SGOT (AST)

Total bilirubin

Alkaline phosphatase

Serum creatinine

Eligibility Checklist

In the opinion of the investigator, is the patient eligible?

Yes

Verification of Postmenopausal Status (Select the item that best describes the patient.)

Bilateral Oophorectomy (1)

No Bilateral Oophorectomy And No Hysterectomy: And > 12 Months Since LMP (2)

Hysterectomy But No Bilateral Oophorectomy: And Age at least 55 At Randomization (3)

Hysterectomy But No Bilateral Oophorectomy: And Age below 55 At Randomization And FSH Within The Postmenopausal Range As Determined By The Investigator (4)

None Of The Above (ineligible) (5)

Date of Last Surgery for Breast Cancer Treatment (Must be within 84 days of randomization)

Month Day Year

Surgical Treatment And Pathology

Did the patient undergo lumpectomy?

Yes

Was the patient diagnosed with invasive or microinvasive breast cancer?

Yes

Did the patient have ductal carcinoma in situ (DCIS) on histologic examination?

Yes

Are the final margins of the resected specimen histologically free of DCIS?

Yes

Were there any clinically or mammographically suspicious masses or clusters of calcification?

Yes

If item 5 is yes, were these suspicious masses or clusters of calcification biopsied?

Yes

If item 5a is yes, are the margins histologically free of DCIS?

Yes

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])

Yes

Are there palpable supraclavicular or infraclavicular nodes? ([If item 7 is yes, attach pathologic documentation that these are not involved with tumor])

Yes

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])

Yes

Did the patient have one or more ipsilateral axillary nodes or intramammary nodes that were positive for tumor on histologic examination?

Yes

Did the patient undergo mastectomy?

Yes

Other Treatment

Has systemic or radiation therapy been given for the current DCIS?

Yes

Has the patient previously taken, or is the patient currently taking, aromatase inhibitors or tamoxifen for treatment or prevention of any disease?

Yes

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.])

Yes

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])

Yes

If item 14 is yes, was this therapy discontinued prior to randomization?

Yes

Contraindications

Has the patient ever been diagnosed with a non-breast malignancy?

Yes

If item 16 is yes, has the patient been disease-free for at least 5 years?

Yes

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

Yes

Does the patient have a prior history of documented cerebral vascular accident or documented transient ischemic attack?

Yes

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?

Yes

Does the patient have a psychiatric or addictive disorder which would preclude obtaining informed consent?

Yes

Does the patient have a prior history of invasive breast cancer or DCIS?

Yes

Does the patient have uncontrolled hypertension?

Yes

Does the patient have uncontrolled diabetes?

Yes

Does the patient have atrial fibrillation, not controlled by medication?

Yes

Pre-entry Studies

Has the patient had a history and physical in the last 6 months?

Yes

Has the patient had a bilateral mammogram within the past 12 months?

Yes

Has the patient had a hysterectomy?

Yes

If item 26 is no, has the patient had a pelvic exam within the past 12 months?

Yes

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