Clinical trial NCT05939830: Omission of ALND in Breast Cancer Patients With Axillary pCR
Official title: Omission of Axillary Lymph Node Dissection in Breast Cancer Patients With Axillary Pathological Complete Response After Neoadjuvant Systemic Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Axillary Lymph Node Dissection
Pathological Complete Response
Neoadjuvant Systemic Therapy
Breast Cancer
Axillary Lymph
Keywords: Breast Cancer
Neoadjuvant Systemic Therapy
Axillary Surgery
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective, single-arm, phase II trial studies axillary lymph node dissection (ALND) to see if it can be safely omitted in breast cancer patients with axillary pathological complete response (pCR) after neoadjuvant systemic therapy (NST). Breast cancer patients with biopsy-proven positive axillary lymph nodes at initial diagnosis, and converted to negative after NST, which is confirmed by Stained region Lymph Node Biopsy(SrLNB), will be enrolled in the study. In other words, a total of 92 patients will be exempted from ALND after SrLNB, and afterwards complete regional node irradiation (RNI) including the axilla. They will also undergo adjuvant chemotherapy, targeted therapy, endocrinotherapy after surgery. These patients will be followed up in the next three years for local-regional recurrence and long-time survival outcome.


Eligibility criteria: Inclusion Criteria:

1. Female aged between 18 and 70 years;
2. Pathologically confirmed invasive breast cancer (regardless of pathological type) with a clinical stage cT1-3;
3. Pathologically confirmed positive axillary lymph nodes with a clinical stage of N1-3;
4. Receiving a full course of neoadjuvant therapy (including neoadjuvant chemotherapy, neoadjuvant targeted therapy, neoadjuvant immunotherapy);
5. Positive axillary lymph nodes successfully stained by carbon nanoparticles injection;
6. All patients are required to undergo immunohistochemical staining for Estrogen Receptor (ER), Progesterone Receptor (PR), human epidermal growth factor receptor 2 (HER2), Ki- 67 proliferation index, and further fluorescence in situ hybridization (FISH) should be performed in HER2 2+ cases;
7. Preoperative clinical assessment (including physical examination, imaging, with or without nomogram assessment) suggests positive axillary lymph nodes converted to negative (ycN0);
8. ECOG score 0 - 1;
9. Patients voluntarily participated in this study and signed the informed consent form

Exclusion Criteria:

1. Bilateral breast cancer;
2. Breast cancer during lactation period or pregnancy;
3. Physical examination or imaging examination confirmed presence of distant metastases;
4. Previous history of malignant tumor;
5. History of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity;
6. History of radiation therapy to the breast or chest;
7. Positive incision margins for breast-conserving surgery/mastectomy;
8. Positive results of intraoperative rapid freeze pathology (including isolated tumor cells and micrometastases) for SrLNB (ypN+);
9. Those who unable to complete the full course of follow-up adjuvant therapy as prescribed for various reasons;
10. Aspartate transaminase (AST) and alanine transaminase (ALT) ≥ 1.5 times the upper limit of normal, alkaline phosphatase（ALP） ≥ 2.5 times the upper limit of normal, total bile ≥ 1.5 times the upper limit of normal, serum creatinine ≥ 1.5 times the upper limit of normal; Left Ventricular Ejection Fractions (LVEF) \< 50% in cardiac ultrasound;
11. Severe coagulation dysfunction, serious systemic disease, or uncontrolled infection;
12. Without personal freedom and independent civil capacity;
13. Those with mental disorders, addictions, who were not eligible for enrollment in the judgment of the investigator.

Primary outcomes:
measure: iDFS: invasive Disease-Free Survival after breast surgery
timeFrame: Up to 3 years after surgery
Secondary outcomes:
measure: LRR: Local-Regional Recurrence after breast surgery
timeFrame: Up to 3 years after surgery
measure: BCRL: Breast Cancer Related Lymphedema
timeFrame: Up to 3 years after surgery
measure: Quality of life (QoL)
timeFrame: Up to 3 years after surgery
measure: Patient-reported arm morbidity
timeFrame: Up to 3 years after surgery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
Study officials:
References: