Sentinel Node Biopsy Alone or With Axillary Dissection After Primary Chemotherapy

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status: Completed

Conditions: Breast Neoplasm Female

Treatments: Procedure: Axillary Dissection; Procedure: Sentinel Node Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04436809

INT180/13

Details and patient eligibility

About

Many doctors believe that breast cancer patients scheduled for pre-operative chemotherapy whose cancer has spread to the axilla (determined by palpation plus ultrasound) should not receive sentinel node biopsy after chemotherapy, but proceed directly to removal of all the axillary lymph nodes.

In this study, breast cancer patients with operable medium-size cancer (T2) scheduled for pre-operative chemotherapy, and a disease-free or a metastatic axilla, are prospectively assigned to receive sentinel node biopsy as part of their post-chemotherapy surgical treatment (whose main aim is to remove the cancer in the breast).

Irrespective of whether the axilla is disease-free or metastatic before chemotherapy, if the removed sentinel nodes are disease-free on histological examination (pN0) after chemotherapy, then no further axillary treatment is given. If however the sentinel nodes contain cancer, then the other axillary lymph nodes will be removed surgically.

The study hypothesis is that, irrespective of whether the axilla is disease-free or metastatic before chemotherapy, patients with negative axillary sentinel nodes on histological examination (pN0) after chemotherapy, and who are no given further axillary treatment, will do as well as pN1 patients whose axillary lymph nodes are completely removed (a more aggressive treatment).

Enrollment: 353 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• cT2 cN0/1 breast cancer
• Scheduled for neoadjuvant chemotherapy,
• Informed consent,

Exclusion criteria

• Previous malignancy at another site
• Synchronous breast cancer at diagnosis
• Distant metastasis at diagnosis
• Clinically involved axilla (cN1) after neoadjuvant chemotherapy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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353 participants in 2 patient groups

SNB only

Other group

Description:

cT2 patients scheduled for primary chemotherapy (with or without a clinically involved axilla - cN0/1) who have disease-free sentinel nodes (pN0) after primary chemotherapy, are directed to "SNB only": i.e. no further treatment to the axilla.

Treatment:

Procedure: Sentinel Node Biopsy

SNB + AD

Other group

Description:

cT2 patients scheduled for primary chemotherapy (with or without a clinically involved axilla - cN0/1) who have metastatic sentinel nodes (pN1) on sentinel node biopsy (SNB) will undergo axillary dissection (AD) i.e. surgical removal of most axillary lymph nodes.

Treatment:

Procedure: Sentinel Node Biopsy

Procedure: Axillary Dissection