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 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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 5611 participants
• Primary outcome timeframe: Before and after surgery (within 30 days of randomization)
• Results posted on: 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=5 Participants	56 years STANDARD_DEVIATION 11.0 • n=7 Participants	56 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	2807 Participants n=5 Participants	2804 Participants n=7 Participants	5611 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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	Arm I:Sentinel Node Resection+Conventional Axillary Dissection n=1449 Participants 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 n=1519 Participants 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.
Morbidity - Number of Participants With Residual Shoulder Abduction Deficit	276 Participants	200 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	Arm I:Sentinel Node Resection+Conventional Axillary Dissection n=1136 Participants 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 n=1151 Participants 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.
Morbidity - Number of Participants With Residual Arm Volume Difference	314 Participants	192 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	Arm I:Sentinel Node Resection+Conventional Axillary Dissection n=1336 Participants 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 n=1371 Participants 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.
Morbidity - Number of Participants With Residual Arm Numbness	408 Participants	103 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	Arm I:Sentinel Node Resection+Conventional Axillary Dissection n=1329 Participants 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 n=1343 Participants 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.
Morbidity - Number of Participants With Residual Arm Tingling	175 Participants	90 Participants

PRIMARY outcome

Timeframe: 8 years

Population: 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	Arm I:Sentinel Node Resection+Conventional Axillary Dissection n=1975 Participants 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 n=2011 Participants 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 Survival	91.8 percentage of patients alive at 8 years Interval 90.4 to 93.3	90.3 percentage of patients alive at 8 years Interval 88.8 to 91.8

PRIMARY outcome

Timeframe: 8 years

Measured at time from randomization to recurrence, second primary, or death to determine the percentage of patients disease free at 8 years.

Outcome measures

Measure	Arm I:Sentinel Node Resection+Conventional Axillary Dissection n=1975 Participants 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 n=2011 Participants 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.
Disease-free Survival as Measured by Breast Cancer Recurrence, Any Second Primary Cancer, and Death From Any Cause in Patients Without a Prior Event.	82.4 percentage pts disease free at 8 years Interval 80.5 to 84.4	81.5 percentage pts disease free at 8 years Interval 79.6 to 83.4

SECONDARY outcome

Timeframe: From the time of randomization until 5 years

Population: 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	Arm I:Sentinel Node Resection+Conventional Axillary Dissection n=3122 Participants 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 n=584 Participants 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.
Pathology Investigation of Sentinel Nodes in Sentinel Node Negative Patients to Identify a Group Who Were Potentially at Increased Risk of Systemic Recurrence	92.5 percentage of patients	89.7 percentage of patients

SECONDARY outcome

Timeframe: From the time of randomization until 5 years

Population: 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	Arm I:Sentinel Node Resection+Conventional Axillary Dissection n=3122 Participants 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 n=584 Participants 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.
Pathology Investigation of Sentinel Nodes in Sentinel Node Negative Patients to Identify a Group Who Were Potentially at Increased Risk of Systemic Recurrence	92.5 percentage distant disease free at 5 yrs	89.7 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	Arm I:Sentinel Node Resection+Conventional Axillary Dissection n=2746 Participants 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 n=2790 Participants 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.
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	2672 Participants	2707 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	74 Participants	83 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	Arm I:Sentinel Node Resection+Conventional Axillary Dissection n=766 Participants 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.
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

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Sentinel Node Resection Followed by Node Examination

Serious events: 8 serious events

Other events: 0 other events

Deaths: 1 deaths

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

Phone: 412-339-5300

Email: regulatory@nsabp.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60