Axillary Sentinel or Targeted Lymph Node Biopsy Alone After Neoadjuvant Chemotherapy in Node-positive Breast Cancer

Phase 2

• Conditions: Breast Cancer Female
• Interventions: Procedure: sentinel lymph node biopsy or targeted axillary dissection alone

• Registration Number: NCT05141630
• Lead Sponsor: Fudan University

Brief Summary

This randomized phase II trial investigates the effectiveness of axillary sentinel or targeted lymph node biopsy alone after neoadjuvant chemotherapy (NAC) in breast cancer patients with initial axillary metastasis. For patients with the low nodal disease after NAC, it is not yet known if radiation therapy causes fewer side effects without compromising loco-regional control.

Detailed Description

To evaluate long-term survival and life quality in patients with biopsy-proven node-positive (cN1-N2) breast cancer receiving NAC, followed by limited nodal burden (less than two positive lymph nodes) by using a (sentinel lymph node biopsy) SLNB or targeted axillary dissection (TAD) technique, and no further axillary surgery.

OUTLINE:

Eligible patients with cT1 to cT3 biopsy-proven N1-2 breast cancer rendered cN0 by NAC underwent SLNB with dual tracer mapping or TAD, and omission of ALND if 2 or more biopsied nodes were identified and less than 2 biopsied nodes were pathologically positve. Metastatic nodes were not routinely clipped, and localization of clipped nodes was performed in these patients. The study was performed in a single cancer center.

After study treatment, patients are followed up at least every 6 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study within 10 years.

Study Timeline

• Study Start: 2014-01-01
• Status Verified: 2021-11
• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-11-20
• Last Update Submitted: 2021-11-20
• Study First Posted: 2021-12-02
• Last Update Posted: 2021-12-02
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
group with axillary sentinel or targeted lymph node biopsy alone	sentinel lymph node biopsy or targeted axillary dissection alone	The patients with stage II to III breast cancer with biopsy-confirmed nodal metastases who convert to cN0 following NAC is recruited. Eligible patients are treated with axillary sentinel or targeted lymph node biopsy alone. Post-surgery radiation therapy will be administered at the discretion of the radiologist and the nodal radiotherapy must be conducted in patients with low nodal disease.

Primary Outcome Measures

Name	Time	Method
Nodal recurrence rate	Up to 5 years after completion of surgery (radiation therapy if done)	a recurrence in the ipsilateral axillary, supraclavicular, or internalmammary nodal basins.

Secondary Outcome Measures

Name	Time	Method
Overall survival	Up to 5 years after completion of surgery (radiation therapy if done)	as the time from completion of radiation therapy until death from any cause
Rate of patients who develop arm lymphedema if there is a 10% increase in the volume of the ipsilateral arm from its pre-surgery volume	Up to 5 years after completion of surgery (radiation therapy if done)
Shoulder function as assessed by arm function test questionnaire at baseline, 1, 3, and 5 years after surgery	Up to 5 years after completion of surgery (radiation therapy if done)
Invasive breast cancer recurrence-free interval	Up to 5 years after completion of surgery (radiation therapy if done)	as the time from completion of radiation therapy until the date of first occurrence of one of the following events: ipsilateral invasive breast tumor, locoregional invasive disease, distant recurrence, contralateral invasive breast cancer, second primary invasive cancer.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China