Invasive Breast CarcinomaSYMPHONYNCT07080944
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC
A study testing SLN identification using technetium-99m, SLN intra-operatory identification with radioguided surgery and Axillary Limph Node Dissection (ALND) in people with Invasive Breast Carcinoma and Sentinel Lymph Node Biopsy (SLNB), run by European Institute of Oncology at 1 site in Italy.
Trial summary
This study will prospectively determine the feasibility and oncological safety of sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NACT) in inflammatory breast cancer patients traditionally considered ineligible for SLNB due to locally advanced cancer with skin/chest wall involvement (cT4d) and heavy… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Invasive Breast Carcinoma, Sentinel Lymph Node Biopsy (SLNB), Neoadjuvant Chemotherapy
- What is being tested?
- SLN identification using technetium-99m, SLN intra-operatory identification with radioguided surgery and Axillary Limph Node Dissection (ALND)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- 12 Dec 2025to Aug 2030
- 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
- Female patients over 18 years of age with clinically and biopsy-proven stage IIIB cT4d cN0-2 M0 breast cancer as assessed by clinical exam and imaging
- Patients receiving NACT and having a nodal complete clinical response (ycN0) as assessed by physical exam and imaging (ultrasound and PET)
- Ability to understand and willingness to sign informed consent document and comply with study procedures
Who cannot join
- Patients with cN3 stage at diagnosis
- Participants with stage IV (metastatic) breast cancer
- Participants with positive contralateral axillary nodes identified on standard imaging studies (mammograpy, MRI, ultrasound) and cito-histologically ascertained
- Patients with a prior history of ipsilateral breast cancer
- Pregnant patients
- Patients after NACT with persistent palpable axillary nodes, as assessed by physical exam, or with persistent pathological axillary nodes, as assessed by imaging
- Patients not consenting to ALND
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan, 20141
Francesca Magnoni, MD, +39 0294371092, francesca.magnoni@ieo.it
Francesca Magnoni, MD
About this study
Official title: Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Inflammatory Breast Cancer: a Prospective Trial
This study will prospectively determine the feasibility and oncological safety of sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NACT) in inflammatory breast cancer patients traditionally considered ineligible for SLNB due to locally advanced cancer with skin/chest wall involvement (cT4d) and heavy nodal burden at presentation (cN1/N2). This study will also assess the identification rate of sentinel lymph-node (SLN) (using single tracer mapping) after NACT in this patient population. Finally, the study will determine the long-term outcome of such cohort.
- Being tested
- SLN identification using technetium-99m, SLN intra-operatory identification with radioguided surgery, Axillary Limph Node Dissection (ALND)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLN identification using technetium-99mProcedure or surgery
SLN Biopsy after pre-surgery positive SLN visualization.
SLN intra-operatory identification with radioguided surgeryProcedure or surgery
SLN biopsy after no pre-surgery SLN visualization using technetium-99m and intra-surgery SLN identification.
Axillary Limph Node Dissection (ALND)Procedure or surgery
Axillary Limph Node Dissection (ALND) after no pre-surgery SLN visualization using technetium-99m and no intra-surgery SLN identification.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Patients with SLN visualization. Receives: Procedure: SLN identification using technetium-99m |
| Group 2a | Experimental | Patients with no pre-surgery SLN visualization and intra-surgery SLN identification. Receives: Procedure: SLN intra-operatory identification with radioguided surgery |
| Group 2b | Active comparator | Patients with no pre-surgery SLN visualization and no intra-surgery SLN identification. Receives: Procedure: Axillary Limph Node Dissection (ALND) |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative SLN identification rate.
Evaluation of the feasibility of SLNB in a selected cohort of IBC patients operated who responded to systemic NACT in the axillary nodes, achieving complete clinical response (ycN0). The feasibility of SLNB, defined as the intraoperative SLN identification rate, will be calculated as the proportion of patients with successfully identified intraoperative SLNs among the enrolled patients.
Measured: 3 Months
Secondary outcomes (4)
Disease-free survival (DFS)
DFS will be defined as the time from surgery to loco-regional recurrence, metastasis, other primary non-breast carcinomas, or death, whichever occurs first.
Measured: 5 years.
Distant recurrence-free survival (DRFS)
DRFS will be defined as the time from surgery to distant recurrence or death from any cause, whichever occurs first.
Measured: 5 years
Breast cancer-specific survival (BCSS)
BCSS will be defined as the time from surgery to death due to breast cancer.
Measured: 5 years
Overall survival (OS)
OS will be defined as the time from surgery to death from any cause.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start12 Dec 2025
- Primary completionJul 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Breast CarcinomaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080944
- Sponsor's protocol ID
- UID 4964
- Other IDs
- L2-371
- Acronym
- SYMPHONY
- Status last verified
- Jan 2026
- First submitted
- 15 Jul 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Inflammatory Breast Cancer: a Prospective Trial
- ClinicalTrials.gov ID
- NCT07080944
- Acronym / sponsor ID
- SYMPHONY / UID 4964
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 23 Jul 2025 (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 will prospectively determine the feasibility and oncological safety of sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NACT) in inflammatory breast cancer patients traditionally considered ineligible for SLNB due to locally advanced cancer with skin/chest wall involvement (cT4d) and heavy nodal burden at presentation (cN1/N2). This study will also assess the identification rate of sentinel lymph-node (SLN) (using single tracer mapping) after NACT in this patient population. Finally, the study will determine the long-term outcome of such cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: SLN identification using technetium-99mPatients with SLN visualization. |
| Group 2a | Experimental | Procedure: SLN intra-operatory identification with radioguided surgeryPatients with no pre-surgery SLN visualization and intra-surgery SLN identification. |
| Group 2b | Active comparator | Procedure: Axillary Limph Node Dissection (ALND)Patients with no pre-surgery SLN visualization and no intra-surgery SLN identification. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients over 18 years of age with clinically and biopsy-proven stage IIIB cT4d cN0-2 M0 breast cancer as assessed by clinical exam and imaging
- Patients receiving NACT and having a nodal complete clinical response (ycN0) as assessed by physical exam and imaging (ultrasound and PET)
- Ability to understand and willingness to sign informed consent document and comply with study procedures
Key exclusion criteria (7 listed)
- Patients with cN3 stage at diagnosis
- Participants with stage IV (metastatic) breast cancer
- Participants with positive contralateral axillary nodes identified on standard imaging studies (mammograpy, MRI, ultrasound) and cito-histologically ascertained
- Patients with a prior history of ipsilateral breast cancer
- Pregnant patients
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 |
|---|---|---|
| SLN identification using technetium-99mSLN Biopsy after pre-surgery positive SLN visualization. | Procedure or surgery | Group 1 |
| SLN intra-operatory identification with radioguided surgerySLN biopsy after no pre-surgery SLN visualization using technetium-99m and intra-surgery SLN identification. | Procedure or surgery | Group 2a |
| Axillary Limph Node Dissection (ALND)Axillary Limph Node Dissection (ALND) after no pre-surgery SLN visualization using technetium-99m and no intra-surgery SLN identification. | Procedure or surgery | Group 2b |
Primary outcome
intraoperative SLN identification rate.
Time frame: 3 Months
Evaluation of the feasibility of SLNB in a selected cohort of IBC patients operated who responded to systemic NACT in the axillary nodes, achieving complete clinical response (ycN0). The feasibility of SLNB, defined as the intraoperative SLN identification rate, will be calculated as the proportion of patients with successfully identified intraoperative SLNs among the enrolled patients.
4 secondary outcomes
Disease-free survival (DFS)
Time frame: 5 years.
Distant recurrence-free survival (DRFS)
Time frame: 5 years
Breast cancer-specific survival (BCSS)
Time frame: 5 years
Overall survival (OS)
Time frame: 5 years
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 6 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SLN identification using technetium-99m, SLN intra-operatory identification with radioguided surgery and Axillary Limph Node Dissection (ALND) in people with Invasive Breast Carcinoma and Sentinel Lymph Node Biopsy (SLNB), run by European Institute of Oncology at 1 site in Italy.
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 3 inclusion and 7 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 6 Jan 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 Italy. 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 Francesca Magnoni, MD (+39 0294371092, francesca.magnoni@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative SLN identification rate. (time frame: 3 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 6 Jan 2026.