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NCT Number: NCT07080944

Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC

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.

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Key information

Conditions

Invasive Breast Carcinoma Neoadjuvant Chemotherapy Sentinel Lymph Node Biopsy (SLNB)

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

European Institute of Oncology

Milan, 20141, Italy

Location status: Recruiting

Location contact

Francesca Magnoni, MD

CONTACT

[email protected]

+39 0294371092

Francesca Magnoni, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

SLN identification using technetium-99m

Procedure

SLN Biopsy after pre-surgery positive SLN visualization.

SLN intra-operatory identification with radioguided surgery

Procedure

SLN biopsy after no pre-surgery SLN visualization using technetium-99m and intra-surgery SLN identification.

Axillary Limph Node Dissection (ALND)

Procedure

Axillary Limph Node Dissection (ALND) after no pre-surgery SLN visualization using technetium-99m and no intra-surgery SLN identification.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Disease-free survival (DFS)

    Time frame: 5 years.

    DFS will be defined as the time from surgery to loco-regional recurrence, metastasis, other primary non-breast carcinomas, or death, whichever occurs first.

  2. Distant recurrence-free survival (DRFS)

    Time frame: 5 years

    DRFS will be defined as the time from surgery to distant recurrence or death from any cause, whichever occurs first.

  3. Breast cancer-specific survival (BCSS)

    Time frame: 5 years

    BCSS will be defined as the time from surgery to death due to breast cancer.

  4. Overall survival (OS)

    Time frame: 5 years

    OS will be defined as the time from surgery to death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Francesca Magnoni, MD

CONTACT

[email protected]

+39 0294371092

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study title

Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Inflammatory Breast Cancer: a Prospective Trial

Acronym: SYMPHONY

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jul 23, 2025
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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