E2108 Step 2 On-Study Form Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer Source Form: NCI FormBuilder:

  1. 8/27/12 8/27/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 9/20/21 9/20/21 -
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September 20, 2021

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Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT01242800 On-Study - E2108 Step 2 On-Study Form - 3130597v1.0

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files

Reporting Period
ECOG Performance Status (Day 1 of this cycle)
Menopausal status (Definitions of Menopausal Status: Postmenopausal: Defined as at least one of the following: 1 age >55 with no spontaneous menses for at least 12 months, or 2 age </= 55 years with no spontaneous menses within the past 12 months e.g. spontaneous or secondary to hysterectomy AND with an FSH level in the postmenopausal range according to local institutional/laboratory standards or > 34.4 IU/L if the institutional range is not available, or 3 history of bilateral oophorectomy, or 4 receiving gonadotropin releasing hormone to suppress ovarian function during the entire period of planned hormonal therapy. Premenopausal: Defined as spontaneous menses occurring within 3 months prior to pre-randomization, and no prior history of bilateral oophorectomy. Perimenopausal: Not meeting criteria for premenopausal or postmenopausal)
Disease Description
Her2/neu expression status by immunohistochemistry
ER Status (Receptor Status as defined by local laboratory; borderline results should be reported as positive)
PgR Status (Receptor Status as defined by local laboratory; borderline results should be reported as positive)
Opposite Breast (Sites of Involvement At Randomization Record an answer for each site including "Other")
Distant Lymph Nodes
Distant Skin/subcutaneous Tissue
Bone Marrow
Other CNS
Treatment Plan
Is further treatment (with Chemotherapy) planned for this patient?
Is further treatment (with Hormone therapy) planned for this patient?
Overall Response Per Recist Criteria - Target, Nontarget And New Lesions
Were circulating tumor cells (CTCs) assessed

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