CTSU ACOSOG Z1071 - "A Phase II Study Evaluating the Role of Sentinel Lymph Node Surgery and Axillary Lymph Node Dissection Following Preoperative Chemotherapy in Women with Node Positive Breast Cancer (T1-4, N1-2, M0) at Initial Diagnosis"

Treatment Plan    (Supplied Drug:  N/A)

Physical Exam & Axillary US

   â

Neo-Adjuv therapy (physician's discretion)*

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REGISTRATION

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Neo-Adjuv therapy (physician's discretion)*

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Physical Exam & Axillary US

   â

SLN & ALND (must be performed at registering facility <12 wks after completion of pre-op chemo)

   â

Follow-up

*  May be registered b/f or after starting pre-op therapy

Eligibility

• Female only, age >18.

• Zubrod 0-1.

• Histol dx of invasive breast cancer, clinical stage T0-4 N1-2 M0 (no inflammatory breast cancer).

• FNA bx or core needle bx of an axillary node documenting nodal disease at time of diagnosis & prior to pre-op chemo.

• Pre-op chemo must be completed or planned.  NOTE:  Pts enrolling on studies w/pre-op chemo may be eligible if SN surgery prior to pre-op chemo was not required in other study.

• No prior ipsilateral axillary surgery (i.e., excisional LN bx or tx of hidradenitis).

• No prior SLN surg/excisional LN bx for path confirmation of axillary status.

• PRESTUDY REQUIREMENTS:

  Completed at dx & prior to pre-op chemo

  • H&P, wt, perf status

  • Axillary US (as part of routine breast US)*

  • FNA or core bx of axillary LN

  • Breast bx

  *      For all pts registered prior to pre-op chemo, submission of pre-tx US images of axilla is required.  For pts registered after pre-op chemo, submission of images is required if images are available.  US images must undergo central review at QARC.

• Signed informed consent.