Refining Local-Regional Therapy for IBC
Refining Local-Regional Therapy for IBC
This Feasibility study is trying to determine:

 -  If Lymphoscintigraphy (imaging of the lymphatic drainage patterns) is effective in
 demonstrating the drainage to the sentinel lymph nodes in patients with inflammatory
 breast cancer.

 -  The likelihood of identifying the sentinel lymph nodes in the operating room, using both
 blue dye and the radioactive substance used for lymphoscintigraphy.

 -  The incidence of lymphedema (arm swelling which occurs after lymph node surgery) in
 women with inflammatory breast cancer

 -  Outcomes for women with inflammatory breast cancer, whether or not the sentinel lymph
 nodes can be identified.
This research study is a Feasibility Study, which means the investigators are collecting
 information from a relatively small group of patients to determine if the sentinel lymph node
 procedure identifies the first nodes that drain the breast in patients with inflammatory
 breast cancer.

 The sentinel node procedure is a standard method to evaluate whether breast cancer has spread
 to the axillary lymph nodes (lymph nodes under the arm) or remains in the lymph nodes under
 the arm after chemotherapy in non-inflammatory breast cancer. "Standard" means that sentinel
 lymph node biopsy is accepted by the majority of the medical community as a suitable method
 to determine if breast cancer has spread to the lymph nodes or remains in the lymph nodes
 after chemotherapy. In women with non-inflammatory breast cancer, these lymph nodes are
 tested first and if they are free of cancer additional lymph nodes are not removed. By safely
 limiting the amount of lymph node surgery to only the sentinel lymph nodes, the likelihood of
 developing lymphedema (arm swelling after lymph node surgery) has declined among women with
 non-inflammatory breast cancer.

 Currently, sentinel lymph node biopsy is not performed in inflammatory breast cancer as there
 are little data supporting that it works or is accurate. For inflammatory breast cancer,
 performing lymphoscintigraphy (imaging study to show the drainage from the breast to the
 lymph nodes) and sentinel lymph node biopsy is investigational. "Investigational" means that
 this is being studied. If in this study it is determined that sentinel lymph nodes can be
 accurately identified and tested in patients with inflammatory breast cancer, this could lead
 to future studies testing whether complete lymph node dissection can be avoided in women with
 inflammatory breast cancer whose sentinel nodes are free of cancer. Thus, potentially also
 reducing the likelihood of lymphedema in patients who receive treatment for inflammatory
 breast cancer.

 The research study procedures include screening for eligibility, imaging evaluation,
 lymphoscintigraphy, sentinel lymph node evaluation, a mandatory research biopsy, research
 blood draws and questionnaires.

 It is expected that about 50 people will take part in this research study at participating
 sites around the United States

 Johns Hopkins University on behalf of the Translational Breast Cancer Research Consortium
 (TBCRC) is supporting this research study by providing funding for the research study. The
 TBCRC is a group of academic medical centers across the United States that work together to
 conduct breast cancer research.
Inclusion Criteria:

 -  Stage III IBC (cT4d cN0-2). Inflammatory breast cancer is defined as the following
 constellation of symptoms (all of the following must be met):

 -  Rapid onset symptoms (6 months or less from time of diagnosis)

 -  Breast erythema, edema and/or peau d'orange and/or warm breast with or without an
 underlying palpable mass

 -  Erythema occupying at least one-third of the breast

 -  Pathologic confirmation (biopsy-proven) invasive breast carcinoma

 -  Women age ≥18 years

 -  ECOG performance status ≤2

 -  Ability to understand and willingness to sign informed consent document and comply
 with study procedures, including baseline research biopsy. If the research biopsy is
 not felt to be reasonably safe or feasible, a waiver must be obtained from the
 Principal Investigator. A formal exception would not be required in this case.

 Exclusion Criteria:

 -  Participants who initiated pre-operative/neoadjuvant therapy prior to registration are
 ineligible.

 -  Participants with Stage IV (metastatic) breast cancer are excluded. The absence of any
 evidence of distant disease on staging studies needs to be confirmed at the time of
 diagnosis (within 42 days from initial presentation) using the staging studies that
 are standard for the participating institution.

 -  Participants with positive contralateral axillary nodes identified on standard imaging
 studies (MMG, MRI, US) are excluded. In participants with clinically suspicious
 axillary nodes, US guided biopsy will be performed prior to registration. If the
 contralateral axillary biopsy is positive, patients will not be eligible. If standard
 imaging does not identify contralateral disease yet drainage to the contralateral
 axillary basin is identified on pre-NAC lymphoscintigraphy, contralateral axillary US
 (if not already performed) will be obtained and any suspicious contralateral axillary
 nodes will undergo US guided biopsy. If the contralateral axillary biopsy is positive,
 patients will not continue on study for the evaluation of the primary endpoint, but
 their data will be used for the descriptive analyses of lymphatic drainage patterns in
 IBC. Contralateral invasive breast cancer without axillary involvement or in-situ
 carcinoma in either breast is allowed.