Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT04636710

Refining Local-Regional Therapy for IBC

Led by Dana-Farber Cancer Institute · Updated on 2025-12-29

50

Participants Needed

1

Research Sites

391 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Refining Local-Regional Therapy for IBC

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women age 18 years or older
  • Diagnosis of Stage III inflammatory breast cancer (cT4d cN0-2) confirmed by biopsy
  • Symptoms appeared within 6 months or less before diagnosis
  • Breast shows erythema, edema, peau d'orange, and/or warmth involving at least one-third of the breast
  • ECOG performance status 2 or better
  • Ability to understand and sign informed consent and comply with study procedures, including baseline research biopsy (or approved waiver if biopsy is not safe)
Not Eligible

You will not qualify if you...

  • Started pre-operative or neoadjuvant therapy before registration
  • Stage IV (metastatic) breast cancer
  • Positive contralateral axillary lymph nodes found on standard imaging or biopsy
  • Confirmed distant disease on staging studies within 42 days of diagnosis
  • Contralateral invasive breast cancer with axillary involvement is excluded; in-situ carcinoma or contralateral breast cancer without axillary involvement is allowed

AI-Screening

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Trial Site Locations

Total: 1 location

1

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

F

Faina Nahklis, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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