Trial · NCT00003830
Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer
NCT00003830, Phase 3, Completed, NSABP Foundation Inc; results first posted 2017-12-13
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer. Trials, record NCT00003830. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00003830
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer
- NCT number
- NCT00003830
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 5,611 participants, actual
- Lead sponsor
- NSABP Foundation Inc
- Conditions
- Breast Cancer
- Interventions
- conventional surgery, Sentinel node resection followed by node examination
- First posted
- 2003-01-28
- Last updated
- 2017-12-13
- Results first posted
- 2017-12-13
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Morbidity - Number of Participants With Residual Shoulder Abduction Deficit | 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. |
| Primary | Morbidity - Number of Participants With Residual Arm Volume Difference | 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 |
| Primary | Morbidity - Number of Participants With Residual Arm Numbness | before and after surgery (within 30 days of randomization) | Morbidity as measured by residual arm numbness |
| Primary | Morbidity - Number of Participants With Residual Arm Tingling | before and after surgery (within 30 days of randomization) | Morbidity as measured by residual arm tingling |
| Primary | Overall Survival | 8 years | Measured at the time from randomization to any death to determine the percentage of patients alive at 8 years |
| Primary | Disease-free Survival as Measured by Breast Cancer Recurrence, Any Second Primary Cancer, and Death From Any Cause in Patients Without a Prior Event. | 8 years | Measured at time from randomization to recurrence, second primary, or death to determine the percentage of patients disease free at 8 years. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | 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) | 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. |
| Secondary | Sensitivity of the Sentinel Node to Determine Presence of Nodal Metastases. | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Morbidity - Number of Participants With Residual Shoulder Abduction Deficit | Before and after surgery (within 30 days of randomization) | Data missing or unknown for some patients | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Morbidity - Number of Participants With Residual Arm Volume Difference | before and after surgery (within 30 days of randomization) | Data missing or unknown for some patients. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Morbidity - Number of Participants With Residual Arm Numbness | before and after surgery (within 30 days of randomization) | Data missing or unknown for some patients | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Morbidity - Number of Participants With Residual Arm Tingling | before and after surgery (within 30 days of randomization) | Data missing or unknown for some patients | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Survival | 8 years | Data missing or unknown for some patients | percentage of patients alive at 8 years | NUMBER |
| PRIMARY | Disease-free Survival as Measured by Breast Cancer Recurrence, Any Second Primary Cancer, and Death From Any Cause in Patients Without a Prior Event. | 8 years | percentage pts disease free at 8 years | NUMBER | |
| SECONDARY | 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 | Data missing or unknown for some patients. | percentage of patients | NUMBER |
| SECONDARY | 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 | Data missing or unknown for some patients | percentage distant disease free at 5 yrs | NUMBER |
| SECONDARY | 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) | Data missing or unknown for some patients. In Arm I, 19 patients did not accept the protocol and another 42 patients did not have a SLN resection leaving 2746 with a SLN resection. In Arm II, 4 declined the protocol treatment and another 10 patients did not have a SLN resection leaving 2790 with a SLN resection. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sensitivity of the Sentinel Node to Determine Presence of Nodal Metastases. | At time of surgery (within 30 days of randomization) | Data not collected for some patients. This analysis as pre-specified in the approved B-32 protocol required that both a SLN resection and an ALND be performed. The patients in Arm II were assigned to have no ALND so were excluded from the analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Morbidity - Number of Participants With Residual Shoulder Abduction Deficit | Arm I:Sentinel Node Resection+Conventional Axillary Dissection | 276 | Participants | ||
| Morbidity - Number of Participants With Residual Shoulder Abduction Deficit | Arm II: Sentinel Node Resection Followed by Node Examination | 200 | Participants | ||
| Morbidity - Number of Participants With Residual Arm Volume Difference | Arm I:Sentinel Node Resection+Conventional Axillary Dissection | 314 | Participants | ||
| Morbidity - Number of Participants With Residual Arm Volume Difference | Arm II: Sentinel Node Resection Followed by Node Examination | 192 | Participants | ||
| Morbidity - Number of Participants With Residual Arm Numbness | Arm I:Sentinel Node Resection+Conventional Axillary Dissection | 408 | Participants | ||
| Morbidity - Number of Participants With Residual Arm Numbness | Arm II: Sentinel Node Resection Followed by Node Examination | 103 | Participants | ||
| Morbidity - Number of Participants With Residual Arm Tingling | Arm I:Sentinel Node Resection+Conventional Axillary Dissection | 175 | Participants | ||
| Morbidity - Number of Participants With Residual Arm Tingling | Arm II: Sentinel Node Resection Followed by Node Examination | 90 | Participants | ||
| Overall Survival | Arm I:Sentinel Node Resection+Conventional Axillary Dissection | 91.8 | 95% Confidence Interval 90.4 to 93.3 | percentage of patients alive at 8 years | |
| Overall Survival | Arm II: Sentinel Node Resection Followed by Node Examination | 90.3 | 95% Confidence Interval 88.8 to 91.8 | percentage of patients alive at 8 years |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I: Conventional Axillary Dissection | 2,807 | |
| Overall Study | STARTED | Arm II: Sentinel Node Resection Followed by Node Examination | 2,804 | |
| Overall Study | COMPLETED | Arm I: Conventional Axillary Dissection | 1,975 | |
| Overall Study | COMPLETED | Arm II: Sentinel Node Resection Followed by Node Examination | 2,011 | |
| Overall Study | NOT COMPLETED | Arm I: Conventional Axillary Dissection | 832 | |
| Overall Study | NOT COMPLETED | Arm II: Sentinel Node Resection Followed by Node Examination | 793 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Anaphylaxis | Immune system disorders | Conventional Axillary Dissection | 5 | 2,788 | |
| serious | Anaphylaxis | Immune system disorders | Sentinel Node Resection Followed by Node Examination | 5 | 2,800 | |
| serious | Infections and infestations - Other, specify | Infections and infestations | Conventional Axillary Dissection | 2 | 2,788 | |
| serious | Infections and infestations - Other, specify | Infections and infestations | Sentinel Node Resection Followed by Node Examination | 0 | 2,800 | |
| serious | Nervous system disorders - Other, specify | Nervous system disorders | Conventional Axillary Dissection | 0 | 2,788 | |
| serious | Nervous system disorders - Other, specify | Nervous system disorders | Sentinel Node Resection Followed by Node Examination | 1 | 2,800 | |
| serious | Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | Conventional Axillary Dissection | 1 | 2,788 | |
| serious | Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | Sentinel Node Resection Followed by Node Examination | 1 | 2,800 | |
| serious | Thromboembolic event | Vascular disorders | Conventional Axillary Dissection | 1 | 2,788 | |
| serious | Thromboembolic event | Vascular disorders | Sentinel Node Resection Followed by Node Examination | 2 | 2,800 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Conventional Axillary Dissection | 0 | 2,788 |
| Total, all-cause mortality | Sentinel Node Resection Followed by Node Examination | 1 | 2,800 |
| Total, other adverse events | Conventional Axillary Dissection | 0 | 2,788 |
| Total, other adverse events | Sentinel Node Resection Followed by Node Examination | 0 | 2,800 |
| Total, serious adverse events | Conventional Axillary Dissection | 9 | 2,788 |
| Total, serious adverse events | Sentinel Node Resection Followed by Node Examination | 8 | 2,800 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA012027 | NATIONAL SURGICAL ADJUVANT BREAST AND BOWEL PROJECT | WOLMARK, NORMAN | NSABP FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 1985 to 2012 |
Source NIH RePORTER
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I:Sentinel Node Resection+Conventional Axillary Dissection vs Arm II: Sentinel Node Resection Followed by Node Examination: Morbidity - Number of Participants With Residual Arm Volume Difference | Trial comparisons |
| Arm I:Sentinel Node Resection+Conventional Axillary Dissection vs Arm II: Sentinel Node Resection Followed by Node Examination: Morbidity - Number of Participants With Residual Arm Numbness | Trial comparisons |
| Arm I:Sentinel Node Resection+Conventional Axillary Dissection vs Arm II: Sentinel Node Resection Followed by Node Examination: Morbidity - Number of Participants With Residual Arm Tingling | Trial comparisons |
| Conventional Axillary Dissection vs Sentinel Node Resection Followed by Node Examination: deaths from any cause | Trial comparisons |
Arm I:Sentinel Node Resection+Conventional Axillary Dissection vs Arm II: Sentinel Node Resection Followed by Node Examination: Morbidity - Number of Participants With Residual Shoulder Abduction Deficit | Trial comparisons |
| Conventional Axillary Dissection vs Sentinel Node Resection Followed by Node Examination: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00003830
GET https://conductscience.org/api/trials/v1/NCT00003830/results?page=2