A Randomized, Phase III Clinical Trial to Compare Sentinel Node Resection to Conventional Axillary Dissection in Clinically Node-Negative Breast Cancer Patients
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- NSABP Foundation Inc
- Enrollment
- 5,611
- Locations
- 78
- Primary Endpoint
- Overall Survival
Study Overview
Brief Summary
RATIONALE: Removing the sentinel lymph nodes and examining them under a microscope may help plan more effective surgery for breast cancer. It is not yet known if surgery to remove the sentinel lymph nodes is more effective with or without removal of the lymph nodes in the armpit in treating breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to remove the sentinel lymph nodes with or without removal of lymph nodes in the armpit in treating women who have breast cancer.
Detailed Description
OBJECTIVES:
- Compare the long term control of regional disease by sentinel node resection vs sentinel node resection followed by conventional axillary dissection in women with breast cancer who are clinically node negative and pathologically sentinel node negative.
- Compare the effect of these two regimens on the overall and disease-free survival of these patients.
- Compare the morbidity associated with these two regimens in these patients.
- Compare the prognostic value of these two regimens in patients who are sentinel node negative or positive by pathology.
- Determine whether a more detailed pathology investigation can identify a group of patients with a potentially increased risk of systemic recurrence who are node negative by pathology.
- Determine the technical success rate of sentinel node dissection and the variability of technical success rate in a broad population of surgeons.
- Determine the sensitivity of the sentinel node to determine the presence of nodal metastases in these patients.
Objectives of quality of life questionnaire in sentinel node-negative patients:
- Compare the severity of self-assessed symptoms and activity limitations of patients treated with these two regimens.
- Compare the severity of self-assessed symptoms and activity limitations after breast cancer surgery in patients whose surgery was on the dominant side vs patients whose surgery was on the non-dominant side.
- Compare the impact of arm edema, range of motion, and sensory neuropathy on self-assessed measures of daily functioning, symptoms, and overall quality of life of patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are stratified according to the surgical treatment plan (lumpectomy vs mastectomy), age (49 and under vs 50 and over), and clinical tumor size (no greater than 2.0 cm vs 2.1-4.0 cm vs at least 4.1 cm). Patients are randomized to one of two surgery arms.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Resectable invasive adenocarcinoma of the breast, confirmed by 1 of the following:
- •Histologically confirmed by core or open biopsy
- •Confirmed by fine needle aspiration cytology AND positive clinical breast examination and ultrasound or mammography
- •Clinically negative lymph nodes
- •No positive ipsilateral axillary lymph nodes
- •No prior removal of ipsilateral axillary lymph nodes
- •No suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless proven nonmalignant by biopsy
- •No ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude
- •Tethering or dimpling of the skin or nipple inversion allowed
- •No bilateral malignancy or mass in the opposite breast that is suspicious for malignancy, unless proven nonmalignant by biopsy
- •No diffuse tumors or multiple malignant tumors in different quadrants of the breast
- •No other prior breast malignancy except lobular carcinoma in situ
- •No prior or concurrent breast implants
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 years and older
- •Menopausal status:
- •Not specified
- •Performance status:
- •Not specified
- •Life expectancy:
- •At least 10 years (excluding diagnosis of cancer)
- •Hematopoietic:
- •Not specified
- •No hepatic systemic disease
- •No renal systemic disease
- •Cardiovascular:
- •No cardiovascular systemic disease
- •No prior malignancy within past 5 years except:
- •Effectively treated squamous cell or basal cell skin cancer
- •Surgically treated carcinoma in situ of the cervix
- •Surgically treated lobular carcinoma in situ of the ipsilateral or contralateral breast
- •No concurrent psychiatric or addictive disorder
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior immunotherapy for this cancer
- •Chemotherapy:
- •No prior chemotherapy for this cancer, including neoadjuvant chemotherapy
- •Endocrine therapy:
- •No prior hormonal therapy for this cancer
- •Radiotherapy:
- •No prior radiotherapy for this cancer
- •See Disease Characteristics
- •No prior breast reduction surgery
- •Prior excisional biopsy or lumpectomy allowed
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I: Conventional axillary dissection
Sentinel node resection immediately followed by axillary dissection
Intervention: conventional surgery (Procedure)
Arm II: Sentinel node resection followed by node examination
Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.
Intervention: Sentinel node resection followed by node examination (Procedure)
Outcomes
Primary Outcomes
Overall Survival
Time Frame: 8 years
Measured at the time from randomization to any death to determine the percentage of patients alive at 8 years
Morbidity - Number of Participants With Residual Shoulder Abduction Deficit
Time Frame: Before and after surgery (within 30 days of randomization)
Morbidity as measured by residual shoulder abduction deficit. Shoulder Abduction Deficit definition: Shoulder range of motion decreased by greater than or equal to 10% as compared with that measured prior to surgery.
Morbidity - Number of Participants With Residual Arm Numbness
Time Frame: before and after surgery (within 30 days of randomization)
Morbidity as measured by residual arm numbness
Morbidity - Number of Participants With Residual Arm Tingling
Time Frame: before and after surgery (within 30 days of randomization)
Morbidity as measured by residual arm tingling
Disease-free Survival as Measured by Breast Cancer Recurrence, Any Second Primary Cancer, and Death From Any Cause in Patients Without a Prior Event.
Time Frame: 8 years
Measured at time from randomization to recurrence, second primary, or death to determine the percentage of patients disease free at 8 years.
Morbidity - Number of Participants With Residual Arm Volume Difference
Time Frame: before and after surgery (within 30 days of randomization)
Morbidity as measured by residual arm volume difference. Residual Arm Volume Difference definition: Arm volume differences greater than or equal to 10% as compared with that measured prior to surgery
Secondary Outcomes
- Pathology Investigation of Sentinel Nodes in Sentinel Node Negative Patients to Identify a Group Who Were Potentially at Increased Risk of Systemic Recurrence(From the time of randomization until 5 years)
- The Percentage of Technically Successful Sentinel Node Resections as Measured by the Proportion of Patients for Whom at Least One Sentinel Node is Identified.(At time of surgery (within 30 days of randomization))
- Sensitivity of the Sentinel Node to Determine Presence of Nodal Metastases.(At time of surgery (within 30 days of randomization))