Description:

NSABP PROTOCOL B-35: FOLLOW-UP FORM Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy Breast Cancer NCT00053898 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A057E605-C97E-3E81-E034-080020C9C0E0

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A057E605-C97E-3E81-E034-080020C9C0E0

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  1. 8/26/12
  2. 3/23/15
Uploaded on:

March 23, 2015

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Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00053898

Form F35 Submit every 6 months for the first 5 years, every 12 months thereafter, and when a protocol event occurs.

Header
Are data amended? (If Yes, circle the amended items in red.)
Cancer Follow-up Status
Patient's Vital Status
Source of Survival Information (if alive)
Cause of Death (if dead)
Was there evidence of recurrence at the time of death?
Has the patient had a documented clinical assessment for this cancer since the last follow-up form?
Total Mastectomy Not Previously Reported?
Fracture Not Previously Reported? (mark all that apply)
Since the last reported follow-up, has the patient had any vaginal hormonal therapy? (e.g., low dose estrogen cream, Vagifem [R], Estring [R])
Bisphosphonates (e.g., Actonel [R], Fosamax [R])
Calcitonin (e.g., Miacalcin [R])
Did patient receive any Tamoxifen/Anastrozole during the past 6 months?
If yes, what percentage of her required pills did she take? (Select the item that best describes her compliance during the 6-month period.)
How was this percentage determined?
Ipsilateral Breast Tumor Recurrence
Has the patient been diagnosed with an invasive or non-invasive recurrence in the ipsilateral breast that has not been previously reported?
First Local-regional Recurrence
Has the patient been diagnosed with first local-regional recurrence since submission of the last follow-up form? (other than IBTR)
Site(s) Diagnosed (mark all first ipsilateral sites that apply)
First Distant Recurrence
Has the patient been diagnosed with first distant recurrence since submission of the last follow-up form?
New Primary Cancer Or Mds
Has a new primary cancer or MDS been diagnosed that has not been previously reported?
Adverse Events
Adverse Event
Grade (highest grade this cycle INCLUDE GRADE 0's)
Has the patient experienced any severe (Grade =3) adverse event, possibly related to study medication, that has not been previously reported? (If yes, identify CTC Terms, 4-Character Codes, circle highest applicable grades, and attach documentation.)

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