Breast CancerNCT07876986
Feasibility and Effectiveness of Sentinel Lymph Node Biopsy in Inflammatory Breast Cancer
A study testing Sentinel node biopsy with blue dye and radioisotope in people with Breast Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study is for participants with inflammatory breast cancer (IBC). The purpose of this study is to find out whether it is possible to take a sample of underarm lymph nodes for participants with IBC. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Sentinel node biopsy with blue dye and radioisotope
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult participants greater than 18 years old
- Diagnosed with inflammatory breast cancer
- Completion of course of Neoadjuvant Chemotherapy
- Surgery completed at Cleveland Clinic
Who cannot join
- Participant is pregnant at the time of surgery
- Pregnant participants will be excluded from participation in the study as injection of blue dye to aid in identification of sentinel lymph nodes is contraindicated in pregnancy due to the risk of fetal harm.
- Metastatic disease at the time of diagnosis or diagnosed prior to surgical treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cleveland Clinic Foundation
Cleveland, Ohio, 44111
Stephanie Valente, DO, 216-492-2235, VALENTS3@ccf.org
Stephanie Valente, DO
About this study
This study is for participants with inflammatory breast cancer (IBC). The purpose of this study is to find out whether it is possible to take a sample of underarm lymph nodes for participants with IBC. The participants will undergo sentinel lymph node biopsy (SLNB) in addition to full axillary lymph node dissection (ALND) during the planned breast cancer surgery. Participants enrolled in the study will first be injected with tracer, then undergo SLNB, and then undergo full ALND.
Read the detailed description
Inflammatory breast cancer is a rare and aggressive type of cancer where the tumor cells invade the lymphatic vessels in the skin. This causes the appearance of red and swollen breasts. Most participants are diagnosed with locally advanced disease, and the standard treatment is chemotherapy, followed by mastectomy and axillary lymph node dissection, radiation treatment, and then adjuvant therapy. But advances in therapy have called into question if mastectomy with ALND is still necessary in participants with IBC, with some physicians advocating for the option of sentinel lymph node biopsy. However, SLNB in participants with IBC has been met with mixed results.
Despite these mixed results, many physicians in the United Stares are still performing SLNB either using blue dyes or dual tracers. The purpose of this study is to find out the rate of identifying sentinel lymph nodes is participants with IBC , whether the sentinel lymph node status correlates with any more positive nodes, and the rates of complete response based on the subtype of IBC.
- Conditions
- Breast Cancer
- Being tested
- Sentinel node biopsy with blue dye and radioisotope
- Keywords
- Breast Cancer, IBC
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel node biopsy with blue dye and radioisotopeDiagnostic test
Participants will be injected with blue dye and radioisotope tracer into the breast of tumor that drains into the first axillary lymph nodes during their planned surgical procedure so that the sentinel lymph nodes can be sampled.
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory Breast Cancer | Experimental | For participants diagnosed with IBC Receives: Diagnostic Test: Sentinel node biopsy with blue dye and radioisotope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of identification of sentinel lymph nodes
Rate of identification of sentinel lymph nodes in participants with IBC will be calculated by dividing the number of cases in which at least 1 sentinel lymph node is identified by the total number of patients in the study who underwent attempted sentinel lymph node biopsy.
Measured: at day 1
Sentinel lymph node status
Examine whether sentinel lymph node status correlates with any additional positive nodes in axilla
Measured: at day 1
Rates of pathologic complete response
Examine rates of pathologic complete response in the breast and axilla based on biological subtype of inflammatory breast cancer.
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Valente, DO, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876986
- Sponsor's protocol ID
- CASE2126
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of IPD is necessary for this protocol
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of Sentinel Lymph Node Biopsy in Inflammatory Breast Cancer
- ClinicalTrials.gov ID
- NCT07876986
- Acronym / sponsor ID
- CASE2126
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, IBC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for participants with inflammatory breast cancer (IBC). The purpose of this study is to find out whether it is possible to take a sample of underarm lymph nodes for participants with IBC. The participants will undergo sentinel lymph node biopsy (SLNB) in addition to full axillary lymph node dissection (ALND) during the planned breast cancer surgery. Participants enrolled in the study will first be injected with tracer, then undergo SLNB, and then undergo full ALND.
Detailed description
Inflammatory breast cancer is a rare and aggressive type of cancer where the tumor cells invade the lymphatic vessels in the skin. This causes the appearance of red and swollen breasts. Most participants are diagnosed with locally advanced disease, and the standard treatment is chemotherapy, followed by mastectomy and axillary lymph node dissection, radiation treatment, and then adjuvant therapy. But advances in therapy have called into question if mastectomy with ALND is still necessary in participants with IBC, with some physicians advocating for the option of sentinel lymph node biopsy. However, SLNB in participants with IBC has been met with mixed results.
Despite these mixed results, many physicians in the United Stares are still performing SLNB either using blue dyes or dual tracers. The purpose of this study is to find out the rate of identifying sentinel lymph nodes is participants with IBC , whether the sentinel lymph node status correlates with any more positive nodes, and the rates of complete response based on the subtype of IBC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inflammatory Breast Cancer | Experimental | Diagnostic Test: Sentinel node biopsy with blue dye and radioisotopeFor participants diagnosed with IBC |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult participants greater than 18 years old
- Diagnosed with inflammatory breast cancer
- Completion of course of Neoadjuvant Chemotherapy
- Surgery completed at Cleveland Clinic
Key exclusion criteria (3 listed)
- Participant is pregnant at the time of surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentinel node biopsy with blue dye and radioisotopeParticipants will be injected with blue dye and radioisotope tracer into the breast of tumor that drains into the first axillary lymph nodes during their planned surgical procedure so that the sentinel lymph nodes can be sampled. | Diagnostic test | Inflammatory Breast Cancer |
Primary outcome
Rate of identification of sentinel lymph nodes
Time frame: at day 1
Rate of identification of sentinel lymph nodes in participants with IBC will be calculated by dividing the number of cases in which at least 1 sentinel lymph node is identified by the total number of patients in the study who underwent attempted sentinel lymph node biopsy.
Sentinel lymph node status
Time frame: at day 1
Examine whether sentinel lymph node status correlates with any additional positive nodes in axilla
Rates of pathologic complete response
Time frame: at day 1
Examine rates of pathologic complete response in the breast and axilla based on biological subtype of inflammatory breast cancer.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. Sharing of IPD is necessary for this protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie Valente, DO principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel node biopsy with blue dye and radioisotope in people with Breast Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Valente, DO ((216) 492-2235, VALENTS3@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of identification of sentinel lymph nodes (time frame: at day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.