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Omission of ALND in Breast Cancer Patients With Axillary pCR

Primary Purpose

Axillary Lymph Node Dissection, Pathological Complete Response, Neoadjuvant Systemic Therapy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stained region Lymph Node Biopsy (SrLNB)
Regional lymph node radiotherapy (RNI) including the axilla
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Axillary Lymph Node Dissection focused on measuring Breast Cancer, Neoadjuvant Systemic Therapy, Axillary Surgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Female aged between 18 and 70 years; Pathologically confirmed invasive breast cancer (regardless of pathological type) with a clinical stage cT1-3; Pathologically confirmed positive axillary lymph nodes with a clinical stage of N1-3; Receiving a full course of neoadjuvant therapy (including neoadjuvant chemotherapy, neoadjuvant targeted therapy, neoadjuvant immunotherapy); Positive axillary lymph nodes successfully stained by carbon nanoparticles injection with/without titanium clip marking; 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; Preoperative clinical assessment (including physical examination, imaging, with or without nomogram assessment) suggests positive axillary lymph nodes converted to negative (ycN0); ECOG score 0 - 1; Patients voluntarily participated in this study and signed the informed consent form Exclusion Criteria: Bilateral breast cancer; Breast cancer during lactation period or pregnancy; Physical examination or imaging examination confirmed presence of distant metastases; Previous history of malignant tumor; History of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity; History of radiation therapy to the breast or chest; Positive incision margins for breast-conserving surgery/mastectomy; Positive results of intraoperative rapid freeze pathology (including isolated tumor cells and micrometastases) for SrLNB (ypN+); Those who unable to complete the full course of follow-up adjuvant therapy as prescribed for various reasons; 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; Severe coagulation dysfunction, serious systemic disease, or uncontrolled infection; Without personal freedom and independent civil capacity; Those with mental disorders, addictions, who were not eligible for enrollment in the judgment of the investigator.

Sites / Locations

  • The First Affiliated Hospital of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omit ALND

Arm Description

Omitting Axillary Lymph Node Dissection (ALND) in SrLNB-proven axillary complete response patients. Finishing regional lymph node irradiation (RNI) including the axilla after surgery.

Outcomes

Primary Outcome Measures

iDFS: invasive Disease-Free Survival after breast surgery
Time interval from the surgery to invasive local-regional recurrence, distant metastasis, contralateral invasive breast cancer, or death from any cause.

Secondary Outcome Measures

LRR: Local-Regional Recurrence after breast surgery
This includes both local and regional recurrences. Local recurrence is defined as recurrence in the ipsilateral breast, chest wall, skin or surgical scar. Regional recurrence is defined as recurrence in the affected lymphatic drainage area, including the axilla, supraclavicular region, subclavicular region, and internal mammary node area.
BCRL: Breast Cancer Related Lymphedema
Objective evaluation of upper limb lymphedema by arm circumference and bioelectrical impedance measurement. In our study, BCRL is diagnosed in two ways:① Relative Volume Change (RVC ) >10% in the affected upper extremity. ②Bioelectrical impedance technology: the impedance ratio is defined as the ratio of the impedance of the healthy upper limb to the impedance of the affected upper limb, and BCRL is diagnosed when the patient's impedance ratio is higher than the mean + 2 standard deviations (SD) of healthy controls. When the two measurements are inconsistent, the former results shall prevail.
Quality of life (QoL)
Patients' subjective assessment of quality of life (QoL) using the Functional Assessment of Cancer Therapy-Breast (FACT-B) . FACT-B is divided into 36 items in 5 domains, namely: physical status (7 items), social/family status (7 items), emotional status (6 items), functional status (7 items) and additional concerns, and each item is classified into five levels: not at all (0), somewhat (1), somewhat (2), fairly (3) and very much (4). Positive items were scored directly from 0 to 4, while negative items (i.e., the larger the number of response options, the worse the quality of life) were scored in reverse. The total score of FACT-B scale ranges from 0 to 144, a higher score means a better quality of life for the patient.
Patient-reported arm morbidity
Patients' subjective assessment of lymphedema using the Quick Disability of the Arm, Shoulder, and Hand (Quick DASH) questionnaires,Quick DASH consists of 11 items, and is a self-rating scale of daily functioning including social functioning and physical activity and upper extremity symptoms. Each item is divided into 5 levels, and the patient's score is calculated as score = [(patient score/number of response items) - 1] × 25, with a total score of 0 to 100, and the higher the score, the greater the degree of upper limb dysfunction.

Full Information

First Posted
July 1, 2023
Last Updated
July 10, 2023
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05939830
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axillary Lymph Node Dissection, Pathological Complete Response, Neoadjuvant Systemic Therapy, Breast Cancer, Axillary Lymph
Keywords
Breast Cancer, Neoadjuvant Systemic Therapy, Axillary Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Omit ALND
Arm Type
Experimental
Arm Description
Omitting Axillary Lymph Node Dissection (ALND) in SrLNB-proven axillary complete response patients. Finishing regional lymph node irradiation (RNI) including the axilla after surgery.
Intervention Type
Procedure
Intervention Name(s)
Stained region Lymph Node Biopsy (SrLNB)
Intervention Description
Before NST, positive lymph nodes would be marked with localized titanium clips under ultrasound guidance, and carbon nanoparticles suspension would be injected into the cortex of the marked lymph nodes and surrounding suspicious lymph nodes for staining. Marked and stained lymph nodes will be removed and biopsied after NST.
Intervention Type
Radiation
Intervention Name(s)
Regional lymph node radiotherapy (RNI) including the axilla
Intervention Description
RNI including the axilla covers the supraclavicular region and entire axillary lymphatic drainage area (region I, II and III) ,and is at a dose of 50 Gy/25 times, with additional prophylactic irradiation of the internal breast lymphatic drainage area for eligible patients.
Primary Outcome Measure Information:
Title
iDFS: invasive Disease-Free Survival after breast surgery
Description
Time interval from the surgery to invasive local-regional recurrence, distant metastasis, contralateral invasive breast cancer, or death from any cause.
Time Frame
Up to 3 years after surgery
Secondary Outcome Measure Information:
Title
LRR: Local-Regional Recurrence after breast surgery
Description
This includes both local and regional recurrences. Local recurrence is defined as recurrence in the ipsilateral breast, chest wall, skin or surgical scar. Regional recurrence is defined as recurrence in the affected lymphatic drainage area, including the axilla, supraclavicular region, subclavicular region, and internal mammary node area.
Time Frame
Up to 3 years after surgery
Title
BCRL: Breast Cancer Related Lymphedema
Description
Objective evaluation of upper limb lymphedema by arm circumference and bioelectrical impedance measurement. In our study, BCRL is diagnosed in two ways:① Relative Volume Change (RVC ) >10% in the affected upper extremity. ②Bioelectrical impedance technology: the impedance ratio is defined as the ratio of the impedance of the healthy upper limb to the impedance of the affected upper limb, and BCRL is diagnosed when the patient's impedance ratio is higher than the mean + 2 standard deviations (SD) of healthy controls. When the two measurements are inconsistent, the former results shall prevail.
Time Frame
Up to 3 years after surgery
Title
Quality of life (QoL)
Description
Patients' subjective assessment of quality of life (QoL) using the Functional Assessment of Cancer Therapy-Breast (FACT-B) . FACT-B is divided into 36 items in 5 domains, namely: physical status (7 items), social/family status (7 items), emotional status (6 items), functional status (7 items) and additional concerns, and each item is classified into five levels: not at all (0), somewhat (1), somewhat (2), fairly (3) and very much (4). Positive items were scored directly from 0 to 4, while negative items (i.e., the larger the number of response options, the worse the quality of life) were scored in reverse. The total score of FACT-B scale ranges from 0 to 144, a higher score means a better quality of life for the patient.
Time Frame
Up to 3 years after surgery
Title
Patient-reported arm morbidity
Description
Patients' subjective assessment of lymphedema using the Quick Disability of the Arm, Shoulder, and Hand (Quick DASH) questionnaires,Quick DASH consists of 11 items, and is a self-rating scale of daily functioning including social functioning and physical activity and upper extremity symptoms. Each item is divided into 5 levels, and the patient's score is calculated as score = [(patient score/number of response items) - 1] × 25, with a total score of 0 to 100, and the higher the score, the greater the degree of upper limb dysfunction.
Time Frame
Up to 3 years after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female aged between 18 and 70 years; Pathologically confirmed invasive breast cancer (regardless of pathological type) with a clinical stage cT1-3; Pathologically confirmed positive axillary lymph nodes with a clinical stage of N1-3; Receiving a full course of neoadjuvant therapy (including neoadjuvant chemotherapy, neoadjuvant targeted therapy, neoadjuvant immunotherapy); Positive axillary lymph nodes successfully stained by carbon nanoparticles injection with/without titanium clip marking; 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; Preoperative clinical assessment (including physical examination, imaging, with or without nomogram assessment) suggests positive axillary lymph nodes converted to negative (ycN0); ECOG score 0 - 1; Patients voluntarily participated in this study and signed the informed consent form Exclusion Criteria: Bilateral breast cancer; Breast cancer during lactation period or pregnancy; Physical examination or imaging examination confirmed presence of distant metastases; Previous history of malignant tumor; History of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity; History of radiation therapy to the breast or chest; Positive incision margins for breast-conserving surgery/mastectomy; Positive results of intraoperative rapid freeze pathology (including isolated tumor cells and micrometastases) for SrLNB (ypN+); Those who unable to complete the full course of follow-up adjuvant therapy as prescribed for various reasons; 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; Severe coagulation dysfunction, serious systemic disease, or uncontrolled infection; Without personal freedom and independent civil capacity; Those with mental disorders, addictions, who were not eligible for enrollment in the judgment of the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jue Wang, MD
Phone
+862568306360
Email
wangjue200011@njmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lingjun Ma, MD
Phone
+8613186693728
Email
malingjun@stu.njmu.edu.cn
Facility Information:
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lingjun Ma
Phone
+8613186693728
Email
malingjun@stu.njmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Omission of ALND in Breast Cancer Patients With Axillary pCR

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