Trial Outcomes & Findings for Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer (NCT NCT00003830)
NCT ID: NCT00003830
Last Updated: 2017-12-13
Results Overview
Morbidity as measured by residual arm numbness
COMPLETED
PHASE3
5611 participants
before and after surgery (within 30 days of randomization)
2017-12-13
Participant Flow
Participant milestones
| Measure |
Arm I: Conventional Axillary Dissection
Sentinel node resection immediately followed by axillary dissection
conventional surgery: Sentinel node resection immediately followed by axillary dissection.
|
Arm II: Sentinel Node Resection Followed by Node Examination
Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
2807
|
2804
|
|
Overall Study
COMPLETED
|
1975
|
2011
|
|
Overall Study
NOT COMPLETED
|
832
|
793
|
Reasons for withdrawal
| Measure |
Arm I: Conventional Axillary Dissection
Sentinel node resection immediately followed by axillary dissection
conventional surgery: Sentinel node resection immediately followed by axillary dissection.
|
Arm II: Sentinel Node Resection Followed by Node Examination
Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.
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.
|
|---|---|---|
|
Overall Study
No follow up data
|
3
|
0
|
|
Overall Study
Sentinel node positive patients
|
829
|
793
|
Baseline Characteristics
Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer
Baseline characteristics by cohort
| Measure |
Conventional Axillary Dissection
n=2807 Participants
Sentinel Node Resection Followed by Conventional Axillary Dissection
|
Sentinel Node Resection Followed by Node Examination
n=2804 Participants
Sentinel node resection followed by node examination
|
Total
n=5611 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 11.2 • n=99 Participants
|
56 years
STANDARD_DEVIATION 11.0 • n=107 Participants
|
56 years
STANDARD_DEVIATION 11.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2807 Participants
n=99 Participants
|
2804 Participants
n=107 Participants
|
5611 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Before and after surgery (within 30 days of randomization)Population: Data missing or unknown for some patients
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.
Outcome measures
| Measure |
Group 2: Negative Node Patients With Occult Metastases
n=1519 Participants
Patients with initially negative sentinel node tumor blocks whose tumors, upon re-examination, were found to have had occult metastases
|
Group 1: Negative Node Patients Without Occult Metastases
n=1449 Participants
Patients with initially negative sentinel node tumors blocks whose tumors, upon re-examination, were not found to have had occult metastases
|
|---|---|---|
|
Morbidity - Number of Participants With Residual Shoulder Abduction Deficit
|
200 Participants
|
276 Participants
|
PRIMARY outcome
Timeframe: before and after surgery (within 30 days of randomization)Population: Data missing or unknown for some patients.
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
Outcome measures
| Measure |
Group 2: Negative Node Patients With Occult Metastases
n=1151 Participants
Patients with initially negative sentinel node tumor blocks whose tumors, upon re-examination, were found to have had occult metastases
|
Group 1: Negative Node Patients Without Occult Metastases
n=1136 Participants
Patients with initially negative sentinel node tumors blocks whose tumors, upon re-examination, were not found to have had occult metastases
|
|---|---|---|
|
Morbidity - Number of Participants With Residual Arm Volume Difference
|
192 Participants
|
314 Participants
|
PRIMARY outcome
Timeframe: before and after surgery (within 30 days of randomization)Population: Data missing or unknown for some patients
Morbidity as measured by residual arm numbness
Outcome measures
| Measure |
Group 2: Negative Node Patients With Occult Metastases
n=1371 Participants
Patients with initially negative sentinel node tumor blocks whose tumors, upon re-examination, were found to have had occult metastases
|
Group 1: Negative Node Patients Without Occult Metastases
n=1336 Participants
Patients with initially negative sentinel node tumors blocks whose tumors, upon re-examination, were not found to have had occult metastases
|
|---|---|---|
|
Morbidity - Number of Participants With Residual Arm Numbness
|
103 Participants
|
408 Participants
|
PRIMARY outcome
Timeframe: before and after surgery (within 30 days of randomization)Population: Data missing or unknown for some patients
Morbidity as measured by residual arm tingling
Outcome measures
| Measure |
Group 2: Negative Node Patients With Occult Metastases
n=1343 Participants
Patients with initially negative sentinel node tumor blocks whose tumors, upon re-examination, were found to have had occult metastases
|
Group 1: Negative Node Patients Without Occult Metastases
n=1329 Participants
Patients with initially negative sentinel node tumors blocks whose tumors, upon re-examination, were not found to have had occult metastases
|
|---|---|---|
|
Morbidity - Number of Participants With Residual Arm Tingling
|
90 Participants
|
175 Participants
|
PRIMARY outcome
Timeframe: 8 yearsPopulation: Data missing or unknown for some patients
Measured at the time from randomization to any death to determine the percentage of patients alive at 8 years
Outcome measures
| Measure |
Group 2: Negative Node Patients With Occult Metastases
n=2011 Participants
Patients with initially negative sentinel node tumor blocks whose tumors, upon re-examination, were found to have had occult metastases
|
Group 1: Negative Node Patients Without Occult Metastases
n=1975 Participants
Patients with initially negative sentinel node tumors blocks whose tumors, upon re-examination, were not found to have had occult metastases
|
|---|---|---|
|
Overall Survival
|
90.3 percentage of patients alive at 8 years
Interval 88.8 to 91.8
|
91.8 percentage of patients alive at 8 years
Interval 90.4 to 93.3
|
PRIMARY outcome
Timeframe: 8 yearsMeasured at time from randomization to recurrence, second primary, or death to determine the percentage of patients disease free at 8 years.
Outcome measures
| Measure |
Group 2: Negative Node Patients With Occult Metastases
n=2011 Participants
Patients with initially negative sentinel node tumor blocks whose tumors, upon re-examination, were found to have had occult metastases
|
Group 1: Negative Node Patients Without Occult Metastases
n=1975 Participants
Patients with initially negative sentinel node tumors blocks whose tumors, upon re-examination, were not found to have had occult metastases
|
|---|---|---|
|
Disease-free Survival as Measured by Breast Cancer Recurrence, Any Second Primary Cancer, and Death From Any Cause in Patients Without a Prior Event.
|
81.5 percentage pts disease free at 8 years
Interval 79.6 to 83.4
|
82.4 percentage pts disease free at 8 years
Interval 80.5 to 84.4
|
SECONDARY outcome
Timeframe: From the time of randomization until 5 yearsPopulation: Data missing or unknown for some patients.
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.
Outcome measures
| Measure |
Group 2: Negative Node Patients With Occult Metastases
n=584 Participants
Patients with initially negative sentinel node tumor blocks whose tumors, upon re-examination, were found to have had occult metastases
|
Group 1: Negative Node Patients Without Occult Metastases
n=3122 Participants
Patients with initially negative sentinel node tumors blocks whose tumors, upon re-examination, were not found to have had occult metastases
|
|---|---|---|
|
Pathology Investigation of Sentinel Nodes in Sentinel Node Negative Patients to Identify a Group Who Were Potentially at Increased Risk of Systemic Recurrence
|
89.7 percentage of patients
|
92.5 percentage of patients
|
SECONDARY outcome
Timeframe: From the time of randomization until 5 yearsPopulation: Data missing or unknown for some patients
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.
Outcome measures
| Measure |
Group 2: Negative Node Patients With Occult Metastases
n=584 Participants
Patients with initially negative sentinel node tumor blocks whose tumors, upon re-examination, were found to have had occult metastases
|
Group 1: Negative Node Patients Without Occult Metastases
n=3122 Participants
Patients with initially negative sentinel node tumors blocks whose tumors, upon re-examination, were not found to have had occult metastases
|
|---|---|---|
|
Pathology Investigation of Sentinel Nodes in Sentinel Node Negative Patients to Identify a Group Who Were Potentially at Increased Risk of Systemic Recurrence
|
89.7 percentage distant disease free at 5 yrs
|
92.5 percentage distant disease free at 5 yrs
|
SECONDARY outcome
Timeframe: At time of surgery (within 30 days of randomization)Population: 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.
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.
Outcome measures
| Measure |
Group 2: Negative Node Patients With Occult Metastases
n=2790 Participants
Patients with initially negative sentinel node tumor blocks whose tumors, upon re-examination, were found to have had occult metastases
|
Group 1: Negative Node Patients Without Occult Metastases
n=2746 Participants
Patients with initially negative sentinel node tumors blocks whose tumors, upon re-examination, were not found to have had occult metastases
|
|---|---|---|
|
The Percentage of Technically Successful Sentinel Node Resections as Measured by the Proportion of Patients for Whom at Least One Sentinel Node is Identified.
Success
|
2707 Participants
|
2672 Participants
|
|
The Percentage of Technically Successful Sentinel Node Resections as Measured by the Proportion of Patients for Whom at Least One Sentinel Node is Identified.
Failure
|
83 Participants
|
74 Participants
|
SECONDARY outcome
Timeframe: At time of surgery (within 30 days of randomization)Population: 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.
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.
Outcome measures
| Measure |
Group 2: Negative Node Patients With Occult Metastases
Patients with initially negative sentinel node tumor blocks whose tumors, upon re-examination, were found to have had occult metastases
|
Group 1: Negative Node Patients Without Occult Metastases
n=766 Participants
Patients with initially negative sentinel node tumors blocks whose tumors, upon re-examination, were not found to have had occult metastases
|
|---|---|---|
|
Sensitivity of the Sentinel Node to Determine Presence of Nodal Metastases.
False Negative
|
—
|
75 Participants
|
|
Sensitivity of the Sentinel Node to Determine Presence of Nodal Metastases.
True Negative
|
—
|
691 Participants
|
Adverse Events
Conventional Axillary Dissection
Sentinel Node Resection Followed by Node Examination
Serious adverse events
| Measure |
Conventional Axillary Dissection
n=2788 participants at risk
Conventional axillary dissection
|
Sentinel Node Resection Followed by Node Examination
n=2800 participants at risk
Sentinel node resection followed by node examination
|
|---|---|---|
|
Immune system disorders
Anaphylaxis
|
0.18%
5/2788
Participants at Risk includes any patient who submitted an AE form.
|
0.18%
5/2800
Participants at Risk includes any patient who submitted an AE form.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.07%
2/2788
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/2800
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/2788
Participants at Risk includes any patient who submitted an AE form.
|
0.04%
1/2800
Participants at Risk includes any patient who submitted an AE form.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.04%
1/2788
Participants at Risk includes any patient who submitted an AE form.
|
0.04%
1/2800
Participants at Risk includes any patient who submitted an AE form.
|
|
Vascular disorders
Thromboembolic event
|
0.04%
1/2788
Participants at Risk includes any patient who submitted an AE form.
|
0.07%
2/2800
Participants at Risk includes any patient who submitted an AE form.
|
Other adverse events
Adverse event data not reported
Additional Information
Director, Department of Regulatory Affairs
NSABP Foundation, Inc
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60