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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Faina Nahklis, MD
fnakhlis1@bwh.harvard.edu
617-632-3891
Time Frame
Start Date: 2021-06-02
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 50
Treatments
Experimental: Sentinal Node Identification
Within standard of care treatment for inflammatory breast cancer, participants will undergo a series of Lymphoscintigraphies: an imaging procedure to determine where their lymphatic system drains from their breast.~* Prior to neoadjuvant chemotherapy~* Day before surgery~These two imaging studies will be compared and the information used during participant's surgery to perform the sentinel node biopsy procedure.~During surgery participants will have a blue dye injected to affected breast to map drainage and identify sentinal nodes. The sentinal nodes will be removed first, followed by standard of care procedure to remove all axillary lymph nodes.~After surgery, a small amount of tissue from the tumor removed during surgery will be evaluated.~Participants will complete a Lymphedema Questionnaire after each Lymphoscintigraphy then every 6 months for 2 years post surgery.
Sponsors
Leads: Dana-Farber Cancer Institute

This content was sourced from clinicaltrials.gov