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SOUTHWEST ONCOLOGY GROUP S0307 PRESTUDY FORM Zoledronate, Clodronate, or Ibandronate in Treating Women Who Have Undergone Surgery for Stage I, Stage II, or Stage III Breast Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DEA0B902-CDD3-54E6-E034-0003BA12F5E7

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DEA0B902-CDD3-54E6-E034-0003BA12F5E7

Keywords:

Clinical Trial

Breast Neoplasms

Pre-Study Form

Versions (3)

12/18/14 12/18/14 - Martin Dugas
1/9/15 1/9/15 - Martin Dugas
8/26/15 8/26/15 - Martin Dugas

Uploaded on:

January 9, 2015

DOI:

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License :

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00127205 Pre-Study - SOUTHWEST ONCOLOGY GROUP S0307 PRESTUDY FORM - 2286938v3.0

English 1

English

Details

No Instruction available.

1 forms

StudyEvent: SOUTHWEST ONCOLOGY GROUP S0307 PRESTUDY FORM
1. No Instruction available.

Administrative documentation

SWOG Patient ID

SWOG Study No.

Registration Step

Patient Initials (L, F M)

Institution/Affiliate

Physician

Participating Group Name

Participating Group Study No.

Participating Group Patient ID

Disease Description

Performance Status

Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)

Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)

Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)

Histologically confirmed primary invasive adenocarcinoma of the breast

Stage I (Stage I)

Stage Ii (Stage II)

Stage Iii (Stage III)

Laboratory Values

Serum creatinine

mg/dL

ULN (mg/dL)

mg/dL

Collection Date (mm/dd/yyyy)

Previous bisphosphonate

Intravenous: C13346 (IV)

Oral (Oral)

None: C41132 (None)

Date of dental examination (mm/dd/yyyy)

Bone Pain

Yes

Bone Metastasis

Yes

Consent For Submission And Banking

Consent for submission and banking

Accepted Tissue Submission (Accepted tissue submission)

Declined Tissue Submission (Declined tissue submission)

Accepted Serum Submission (Accepted serum submission)

Declined Serum Submission (Declined serum submission)

Patient Characteristics

Menopausal status (select one:)

Pre (<6 Mo Since Lmp And No Prior Bilateral Ovariectomy And Not On Estrogen Replacement) (Pre (< 6 mo since LMP and no prior bilateral ovariectomy and not on estrogen replacement))

Post (prior Bilateral Ovariectomy Or >12 Mo Since Lmp With No Prior Hysterectomy) (Post (prior bilateral ovariectomy OR > 12 mo since LMP with no prior hysterectomy))

Above Categories Not Applicable And Age <50 (Above not applicable AND age < 50)

Above Categories Not Applicable And Age >= 50 (Above not applicable AND age >=50)

Height

Weight

BSA

m^2

Disease Description

Date of Initial Diagnosis of Primary Tumor

Tumor Laterality (select one:)

Left (Left)

Right (Right)

Bilateral (Bilateral)

Pathologic Primary Tumor Size (cm.)

Number of Positive Lymph Nodes (If sentinel node biopsy and axillary node dissection were performed, enter the sum of positive nodes.)

ER Status

Negative (ER-)

Positive (ER+)

PgR Status

Negative (PgR-)

Positive (PgR+)

Was HER-2/neu status determined?

Yes

If Yes, HER2/neu final diagnosis

Positive (Positive)

Negative (Negative)

Equivocal (Equivocal)

Treatment With Statins

Is the patient currently taking a statin (atorvastatin Lipitor, pravastatin Pravachol, simvastatin Zocor, lovastatin Mevacor, fluvastatin Lescol, rosuvastatin Crestor?)

Yes

Length of time on statin

< 1 Yr (< 1 yr)

1-2 Yrs (1-2 yrs)

2-3 Yrs (2-3 yrs)

3-4 Yrs (3-4 yrs)

>4 Yrs (>4 yrs)

Patient Preference

If oral and intravenous bisphosphonates are equally effective in preventing breast cancer recurrence in the bone, which would the patient prefer to receive? (Note that the answer to this question will not in any way affect which treatment the patient is randomly assigned to on this study.)

Oral (Oral)

Intravenous (Intravenous)

Prior Treatment Related To This Cancer

Most Extensive Primary Surgery (select one:)

Partial Mastectomy, Lumpectomy Or Excisional Biopsy (Partial mastectomy/lumpectomy/excisional biopsy)

Mastectomy, Nos (Mastectomy, NOS)

Date of Most Extensive Primary Surgery (If required, use last re-excision date)

Was sentinel node sampling performed?

Yes

Sentinel Node Biopsy Date

Sentinel Node Biopsy Results

Positive (Positive)

Negative (Negative)

Was axillary dissection performed?

Yes

Date of Axillary Dissection

SWOG Patient ID

SWOG Study No.

Registration Step

Patient Initials (L, F M)

Systemic Treatment For This Cancer

Chemotherapy (select one:)

Currently Receiving (Currently receiving)

Planned (Planned)

Not Planned (Not planned)

Completed (Completed)

Date chemotherapy completed (If completed,)

Hormone therapy (select one:)

Currently Receiving (Currently receiving)

Planned (Planned)

Not Planned (Not planned)

If currently receiving

Serm (SERM)

Aromatase Inhibitor (Aromatase inhibitor)

Ovarian Suppression (Ovarian suppression)

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