Recruiting

Local-Regional Therapy

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT04636710

Conditions

Breast Cancer

Inflammatory Breast Cancer

Sentinel Lymph Node

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lymphoscintigraphy

Study Details

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

Breast Cancer

Inflammatory Breast Cancer

Sentinel Lymph Node

Study ID

NCT04636710

Start date

Jun 2, 2021

Status verified date

Dec, 2025

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

Lymphoscintigraphy

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.

Primary outcome measure

  • Sentinel Lymph Node (SLN) identification rate [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Faina Nahklis, MD

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

Locations

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Faina Nakhlis, MD

617-983-7777fnakhlis@partners.org

Principal Investigator:

Faina Nakhlis, MD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Dec 29, 2025

Last verified

Dec, 2025

Keywords

  • Breast Cancer
  • Inflammatory Breast Cancer
  • Sentinel Lymph Node

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2025-12-29.