Breast CancerNCT04636710
Refining Local-Regional Therapy for IBC
A study testing Lymphoscintigraphy in people with Breast Cancer and Inflammatory Breast Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Inflammatory Breast Cancer, Sentinel Lymph Node
- What is being tested?
- Lymphoscintigraphy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2021to 1 Dec 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
- 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.
Who cannot join
- 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.
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, 1 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Faina Nakhlis, MD, 617-983-7777, fnakhlis@partners.org
Faina Nakhlis, MD
About this study
Official title: Refining Local-Regional Therapy for Inflammatory Breast Cancer (IBC)
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.
Read the detailed description
This research study is a Feasibility Study, which means the investigators are collecting information from a relatively small group of patients to determine if the sentinel lymph node procedure identifies the first nodes that drain the breast in patients with inflammatory breast cancer.
The sentinel node procedure is a standard method to evaluate whether breast cancer has spread to the axillary lymph nodes (lymph nodes under the arm) or remains in the lymph nodes under the arm after chemotherapy in non-inflammatory breast cancer. "Standard" means that sentinel lymph node biopsy is accepted by the majority of the medical community as a suitable method to determine if breast cancer has spread to the lymph nodes or remains in the lymph nodes after chemotherapy. In women with non-inflammatory breast cancer, these lymph nodes are tested first and if they are free of cancer additional lymph nodes are not removed. By safely limiting the amount of lymph node surgery to only the sentinel lymph nodes, the likelihood of developing lymphedema (arm swelling after lymph node surgery) has declined among women with non-inflammatory breast cancer.
Currently, sentinel lymph node biopsy is not performed in inflammatory breast cancer as there are little data supporting that it works or is accurate. For inflammatory breast cancer, performing lymphoscintigraphy (imaging study to show the drainage from the breast to the lymph nodes) and sentinel lymph node biopsy is investigational. "Investigational" means that this is being studied. If in this study it is determined that sentinel lymph nodes can be accurately identified and tested in patients with inflammatory breast cancer, this could lead to future studies testing whether complete lymph node dissection can be avoided in women with inflammatory breast cancer whose sentinel nodes are free of cancer. Thus, potentially also reducing the likelihood of lymphedema in patients who receive treatment for inflammatory breast cancer.
The research study procedures include screening for eligibility, imaging evaluation, lymphoscintigraphy, sentinel lymph node evaluation, a mandatory research biopsy, research blood draws and questionnaires.
It is expected that about 50 people will take part in this research study at participating sites around the United States
Johns Hopkins University on behalf of the Translational Breast Cancer Research Consortium (TBCRC) is supporting this research study by providing funding for the research study. The TBCRC is a group of academic medical centers across the United States that work together to conduct breast cancer research.
- Being tested
- Lymphoscintigraphy
- Keywords
- Breast Cancer, Inflammatory Breast Cancer, Sentinel Lymph Node
- Medical subject headings
- Breast Neoplasms, Inflammatory Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LymphoscintigraphyProcedure or surgery
Also called Sentinel lymph node mapping
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Lymphoscintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months
Secondary outcomes (4)
Prevalence of lymphedema
Assess the prevalence of lymphedema following comprehensive local therapy (surgery + regional RT) using the patient-reported Lymphedema Symptom Intensity and Distress Survey - Arm (LSIDS-A) (Appendix A).
Measured: Every 6 months post surgery up to 2 years
Local-regional recurrence free survival rate (LRRFS)
Duration of time from surgery until invasive ipsilateral local-regional recurrence or death from any cause; in the absence of an event, LRRFS will be censored at the date last know alive and free from local regional recurrence (LRR).
Measured: Within 2 years from surgery
Distant recurrence-free survival rate (DRFS)
Duration of time from surgery until distant recurrence or death from any cause; in the absence of an event, DRFS will be censored at the date last know alive and free from distant recurrence
Measured: Within 2 years from surgery
Disease-free survival (DFS)
Duration of time from surgery until invasive ipsilateral local regional recurrence, invasive contralateral breast cancer, distant recurrence, or death from any cause; in the absence of an event, DFS will be censored at the date last know alive and free from all events.
Measured: Within 2 yhears from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start2 Jun 2021
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 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 Dana-Farber Cancer InstituteThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faina Nakhlis, MD, Dana-Farber Cancer Institute
- Investigators
- Faina Nahklis, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636710
- Sponsor's protocol ID
- 20-151
- Status last verified
- Dec 2025
- First submitted
- 13 Nov 2020
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refining Local-Regional Therapy for Inflammatory Breast Cancer (IBC)
- ClinicalTrials.gov ID
- NCT04636710
- Acronym / sponsor ID
- 20-151
- Keywords
- Breast Cancer, Inflammatory Breast Cancer, Sentinel Lymph Node
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 19 Nov 2020 (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 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.
Detailed description
This research study is a Feasibility Study, which means the investigators are collecting information from a relatively small group of patients to determine if the sentinel lymph node procedure identifies the first nodes that drain the breast in patients with inflammatory breast cancer.
The sentinel node procedure is a standard method to evaluate whether breast cancer has spread to the axillary lymph nodes (lymph nodes under the arm) or remains in the lymph nodes under the arm after chemotherapy in non-inflammatory breast cancer. "Standard" means that sentinel lymph node biopsy is accepted by the majority of the medical community as a suitable method to determine if breast cancer has spread to the lymph nodes or remains in the lymph nodes after chemotherapy. In women with non-inflammatory breast cancer, these lymph nodes are tested first and if they are free of cancer additional lymph nodes are not removed. By safely limiting the amount of lymph node surgery to only the sentinel lymph nodes, the likelihood of developing lymphedema (arm swelling after lymph node surgery) has declined among women with non-inflammatory breast cancer.
Currently, sentinel lymph node biopsy is not performed in inflammatory breast cancer as there are little data supporting that it works or is accurate. For inflammatory breast cancer, performing lymphoscintigraphy (imaging study to show the drainage from the breast to the lymph nodes) and sentinel lymph node biopsy is investigational. "Investigational" means that this is being studied. If in this study it is determined that sentinel lymph nodes can be accurately identified and tested in patients with inflammatory breast cancer, this could lead to future studies testing whether complete lymph node dissection can be avoided in women with inflammatory breast cancer whose sentinel nodes are free of cancer. Thus, potentially also reducing the likelihood of lymphedema in patients who receive treatment for inflammatory breast cancer.
The research study procedures include screening for eligibility, imaging evaluation, lymphoscintigraphy, sentinel lymph node evaluation, a mandatory research biopsy, research blood draws and questionnaires.
It is expected that about 50 people will take part in this research study at participating sites around the United States
Johns Hopkins University on behalf of the Translational Breast Cancer Research Consortium (TBCRC) is supporting this research study by providing funding for the research study. The TBCRC is a group of academic medical centers across the United States that work together to conduct breast cancer research.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sentinal Node Identification | Experimental | Procedure: LymphoscintigraphyWithin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Stage III IBC (cT4d cN0-2). Inflammatory breast cancer is defined as the following constellation of symptoms (all of the following must be met):
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| LymphoscintigraphyAlso: Sentinel lymph node mappingAn 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. | Procedure or surgery | Sentinal Node Identification |
Primary outcome
Sentinel Lymph Node (SLN) identification rate
Time frame: Up to 6 months
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.
4 secondary outcomes
Prevalence of lymphedema
Time frame: Every 6 months post surgery up to 2 years
Local-regional recurrence free survival rate (LRRFS)
Time frame: Within 2 years from surgery
Distant recurrence-free survival rate (DRFS)
Time frame: Within 2 years from surgery
Disease-free survival (DFS)
Time frame: Within 2 yhears from surgery
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 29 Dec 2025.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Faina Nahklis, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphoscintigraphy in people with Breast Cancer and Inflammatory Breast Cancer, run by Dana-Farber Cancer Institute 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 8 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: looking for participants now, as of the sponsor's last update on 29 Dec 2025. 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 Faina Nahklis, MD (617-632-3891, fnakhlis1@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sentinel Lymph Node (SLN) identification rate (time frame: Up to 6 months). 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 29 Dec 2025.