Refining Local-Regional Therapy for IBC

NCT04636710 | Recruiting DMC

• 1 other identifier: 20-151
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sentinel Lymph Node; Breast Cancer; Inflammatory Breast Cancer

Keywords

Breast Cancer; Inflammatory Breast Cancer; Sentinel Lymph Node

Outcome Measures

Primary Outcomes (1)

• Sentinel Lymph Node (SLN) identification rate

  The identification rate will be calculated as a ratio of the number of patients in whom SLN(s) were successfully identified over the total number of patients in whom SLN mapping was attempted.

  Up to 6 months

Secondary Outcomes (4)

• Prevalence of lymphedema

  Every 6 months post surgery up to 2 years

• Local-regional recurrence free survival rate (LRRFS)

  Within 2 years from surgery

• Distant recurrence-free survival rate (DRFS)

  Within 2 years from surgery

• Disease-free survival (DFS)

  Within 2 yhears from surgery

Study Arms (1)

Sentinal Node Identification

EXPERIMENTAL

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.

Procedure: Lymphoscintigraphy

Interventions

Lymphoscintigraphy PROCEDURE

An imaging procedure using an injected radioactive substance or dye to identify lymph drainage A doctor reviews the images to identify the sentinel lymph nodes based on where the dye goes to first.

Also known as: Sentinel lymph node mapping

Sentinal Node Identification

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Inflammatory Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Faina Nahklis, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faina Nahklis, MD

CONTACT

617-632-3891; fnakhlis1@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 19, 2020
• Study Start: June 2, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)