Back to resultsOmission of SLNB in cN0 Early Breast Cancer
Primary Purpose
Breast Cancer, Clinically Assessed Negative Axillary Lymph Nodes, Sentinel Lymph Node
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Omit SLNB
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, clinically assessed negative axillary lymph nodes, sentinel lymph node biopsy
Eligibility Criteria
Inclusion Criteria: Female patients aged 18-70 years; Pathologically confirmed invasive breast cancer (regardless of pathological type) with a tumor diameter ≤ 3 cm, and planning to undergo breast surgery; Negative axillary lymph nodes assessed by physical examination and imaging (2 or more of the following tests including ultrasound, breast MRI, breast PET-CT, breast PET-MRI, breast PET); 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; Good compliance, normal comprehension and ability to receive treatment and follow-up as required; ECOG score 0-1; Patients volunteered for this study and signed the informed consent form. Exclusion Criteria: Bilateral/lactating/pregnant breast cancer; Previous history of malignant tumor or neoplasm; Clinical or imaging confirmation of distant metastasis; History of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity; Prior history of radiotherapy to the breast or chest; Positive pathological margins after breast-conserving surgery or mastectomy; Severe coagulation disorder, or a serious systemic disease, or an uncontrollable infection; Aspartate aminortransferse (AST) and Alanine aminotransferase (ALT) ≥ 1.5 times the upper limit of normal, alkaline phosphatase ≥ 2.5 times the upper limit of normal, total bilirubin ≥ 1.5 times the upper limit of normal, serum creatinine ≥ 1.5 times the upper limit of normal; left ventricular injection fraction (LVEF) < 50% on cardiac ultrasound; Inability to complete the full course of follow-up adjuvant therapy as prescribed by the doctor for various reasons; No personal freedom and independent civil capacity; Presence of mental disorders, addictions, etc; Not eligible for enrollmentas as judged by the investigator.
Sites / Locations
- the First Affiliated Hospital of Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OMSLNB
Arm Description
Outcomes
Primary Outcome Measures
invasive Disease-Free Survival (iDFS)
Time interval from the surgery to invasive local-regional recurrence, distant metastasis, contralateral invasive breast cancer, or death from any cause.
Secondary Outcome Measures
Breast cancer-related lymphoedema (BCRL)
Objective evaluation of breast cancer-related lymphoedema (BCRL) by arm circumference measurements and bioelectrical impedance technology. 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.
Locoregional Recurrence (LRR)
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.
Local Recurrence (LR)
Local recurrence is defined as recurrence in the ipsilateral breast, chest wall, skin or surgical scar.
Regional Recurrence (RR)
Regional recurrence is defined as recurrence in the affected lymphatic drainage area, including the axilla, supraclavicular region, subclavicular region, and internal mammary node area.
Full Information
NCT ID
NCT05935150
First Posted
June 2, 2023
Last Updated
July 4, 2023
Sponsor
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05935150
Brief Title
Omission of SLNB in cN0 Early Breast Cancer
Official Title
Omission of Sentinel Lymph Node Biopsy (SLNB ) in Early Breast Cancer Patients With Clinically Assessed Negative Axillary Lymph Nodes (cN0): a Phase II, Prospective Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2023 (Actual)
Primary Completion Date
July 1, 2027 (Anticipated)
Study Completion Date
October 1, 2027 (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
OMSLNB is a prospective, non-inferiority, single-arm clinical trial designed to omit sentinel lymph node biopsy in patients with clinically assessed negative axillary lymph nodes early breast cancer (tumor<3cm) to decrease the edema of upper arm, and finally improve the quality of life of the patients. Patients enrolled must have had 2 or more of the following radiographic examinations, including ultrasound, breast MRI, breast PET-CT, breast PET-MRI, breast PET-MRI and be diagnosed as axillary lymph nodes negative, and be planning to undergo breast surgery. Types of breast surgery are not limited to breast-conserving surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Clinically Assessed Negative Axillary Lymph Nodes, Sentinel Lymph Node
Keywords
breast cancer, clinically assessed negative axillary lymph nodes, sentinel lymph node biopsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
311 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OMSLNB
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Omit SLNB
Intervention Description
Omit SLNB in cN0 EBC patients. All patients enrolled have to receive two or more of the following radiographic examinations including ultrasound, breast MRI, breast PET-CT, breast PET-MRI, and breast PET.
Primary Outcome Measure Information:
Title
invasive Disease-Free Survival (iDFS)
Description
Time interval from the surgery to invasive local-regional recurrence, distant metastasis, contralateral invasive breast cancer, or death from any cause.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Breast cancer-related lymphoedema (BCRL)
Description
Objective evaluation of breast cancer-related lymphoedema (BCRL) by arm circumference measurements and bioelectrical impedance technology. 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
3 years
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
3 years
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
3 years
Title
Locoregional Recurrence (LRR)
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
3 years
Title
Local Recurrence (LR)
Description
Local recurrence is defined as recurrence in the ipsilateral breast, chest wall, skin or surgical scar.
Time Frame
3 years
Title
Regional Recurrence (RR)
Description
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
3 years
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 patients aged 18-70 years;
Pathologically confirmed invasive breast cancer (regardless of pathological type) with a tumor diameter ≤ 3 cm, and planning to undergo breast surgery;
Negative axillary lymph nodes assessed by physical examination and imaging (2 or more of the following tests including ultrasound, breast MRI, breast PET-CT, breast PET-MRI, breast PET);
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;
Good compliance, normal comprehension and ability to receive treatment and follow-up as required;
ECOG score 0-1;
Patients volunteered for this study and signed the informed consent form.
Exclusion Criteria:
Bilateral/lactating/pregnant breast cancer;
Previous history of malignant tumor or neoplasm;
Clinical or imaging confirmation of distant metastasis;
History of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity;
Prior history of radiotherapy to the breast or chest;
Positive pathological margins after breast-conserving surgery or mastectomy;
Severe coagulation disorder, or a serious systemic disease, or an uncontrollable infection;
Aspartate aminortransferse (AST) and Alanine aminotransferase (ALT) ≥ 1.5 times the upper limit of normal, alkaline phosphatase ≥ 2.5 times the upper limit of normal, total bilirubin ≥ 1.5 times the upper limit of normal, serum creatinine ≥ 1.5 times the upper limit of normal; left ventricular injection fraction (LVEF) < 50% on cardiac ultrasound;
Inability to complete the full course of follow-up adjuvant therapy as prescribed by the doctor for various reasons;
No personal freedom and independent civil capacity;
Presence of mental disorders, addictions, etc;
Not eligible for enrollmentas as judged by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jue Wang, MD
Phone
025-68306360
Email
wangjue200011@njmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xuan Li, MD
Phone
18154489540
Email
lixuan1204@stu.njmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoming Zha, MD
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jue Wang, MD
Phone
025-68306360
Email
wangjue200011@njmu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Omission of SLNB in cN0 Early Breast Cancer
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