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)*

   â

REGISTRATION

   â

Neo-Adjuv therapy (physician's discretion)*

   â

Physical Exam & Axillary US

   â

SLN & ALND

   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 T1-4 N1-2 (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 pregnant or nursing women.

• 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

  • Pregnancy test (if applicable)

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

  • FNA or core bx of axillary LN

  • Breast bx

  • Image submission to QARC#

  *      If available, pre-tx US images of axilla should be submitted for central review.  Post-tx US images of axilla are required.

  #     Also required at end of pre-op therapy & w/i 4 wks prior to surgery. 

  @   If post-tx restaging US is conducted pre-regist, then it does not have to be repeated if it is w/i 4 wks pre-surg.

• Signed informed consent.