Improving treatment for inflammatory breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This feasibility study aims to evaluate the effectiveness of lymphoscintigraphy in identifying sentinel lymph nodes in patients with inflammatory breast cancer. It will assess the likelihood of successfully locating these nodes during surgery using both blue dye and a radioactive substance. Additionally, the study will monitor the incidence of lymphedema following lymph node surgery and gather outcomes related to the identification of sentinel lymph nodes in this patient population. The goal is to gather preliminary data that could inform future treatment protocols for inflammatory breast cancer.

Why it matters

Who can join: the full rules

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.

Where it's running

• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Faina Nahklis, MD — Dana-Farber Cancer Institute
• Study coordinator: Faina Nahklis, MD
• Email: fnakhlis1@bwh.harvard.edu
• Phone: 617-632-3891

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using advanced imaging technology for early-stage breast cancer surgery

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• Using a low dose of Magtrace to locate lymph nodes in breast cancer patients

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  Recruiting Phase 2 Vastra Gotaland Region · Gothenburg · NCT06169072

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.