Refining Local-Regional Therapy for Inflammatory Breast Cancer (IBC)

Protocol # :
Breast Cancer
Inflammatory Breast Cancer
Sentinel Lymph Node
Feasibility / Pilot
Disease Sites
Principal Investigator
Nakhlis, Faina

Trial Description

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.

Eligibility Requirements

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

- 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.