Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00003830 |
Recruitment Status :
Completed
First Posted : January 28, 2003
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Procedure: conventional surgery Procedure: Sentinel node resection followed by node examination | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5611 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Phase III Clinical Trial to Compare Sentinel Node Resection to Conventional Axillary Dissection in Clinically Node-Negative Breast Cancer Patients |
Study Start Date : | May 1999 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | February 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Arm I: Conventional axillary dissection
Sentinel node resection immediately followed by axillary dissection
|
Procedure: conventional surgery
Sentinel node resection immediately followed by axillary dissection. |
Experimental: Arm II: Sentinel node resection followed by node examination
Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.
|
Procedure: Sentinel node resection followed by node examination
Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node. |
- 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 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
- 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
- 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
- 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.
- Pathology Investigation of Sentinel Nodes in Sentinel Node Negative Patients to Identify a Group Who Were Potentially at Increased Risk of Systemic Recurrence [ Time Frame: From the time of randomization until 5 years ]Percentage of patients distant disease-free at 5 years. Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.
- Pathology Investigation of Sentinel Nodes in Sentinel Node Negative Patients to Identify a Group Who Were Potentially at Increased Risk of Systemic Recurrence [ Time Frame: From the time of randomization until 5 years ]Measured at time from randomization to any distant cancer or death to determine percentage of patients distant disease free at 5 years. Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.
- The Percentage of Technically Successful Sentinel Node Resections as Measured by the Proportion of Patients for Whom at Least One Sentinel Node is Identified. [ Time Frame: At time of surgery (within 30 days of randomization) ]Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.
- Sensitivity of the Sentinel Node to Determine Presence of Nodal Metastases. [ Time Frame: At time of surgery (within 30 days of randomization) ]Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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:
Age:
- 18 years and older
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Not specified
Life expectancy:
- At least 10 years (excluding diagnosis of cancer)
Hematopoietic:
- Not specified
Hepatic:
- No hepatic systemic disease
Renal:
- No renal systemic disease
Cardiovascular:
- No cardiovascular systemic disease
Other:
-
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
Surgery:
- See Disease Characteristics
- No prior breast reduction surgery
- Prior excisional biopsy or lumpectomy allowed

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003830

Principal Investigator: | Norman Wolmark, MD | NSABP Foundation Inc |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | NSABP Foundation Inc |
ClinicalTrials.gov Identifier: | NCT00003830 |
Other Study ID Numbers: |
NSABP B-32 U10CA012027 ( U.S. NIH Grant/Contract ) CDR0000066987 |
First Posted: | January 28, 2003 Key Record Dates |
Results First Posted: | December 13, 2017 |
Last Update Posted: | December 13, 2017 |
Last Verified: | November 2017 |
stage I breast cancer stage II breast cancer |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |