Trial Outcomes & Findings for Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases (NCT NCT00072293)

NCT ID: NCT00072293

Last Updated: 2018-01-23

Results Overview

Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to first evidence of invasive relapse at any site, second primary tumor (contralateral or non-breast) or death.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 931 participants
• Primary outcome timeframe: 5-year estimate reported after a median follow-up of 60 months
• Results posted on: 2018-01-23

Participant Flow

Accrual began April 1, 2001 and closed February 28, 2010, after 934 patients from 27 centers in Europe, South America and Australia were randomized.

Participant milestones

Measure	Axillary Dissection Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment. Axillary lymph node dissection: Axillary lymph node dissection	No Axillary Dissection Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment. No axillary lymph node dissection: Therapeutic conventional surgery
Overall Study STARTED	465	469
Overall Study COMPLETED	464	467
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Axillary Dissection Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment. Axillary lymph node dissection: Axillary lymph node dissection	No Axillary Dissection Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment. No axillary lymph node dissection: Therapeutic conventional surgery
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases

Baseline characteristics by cohort

Measure	Axillary Dissection n=464 Participants Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment. Axillary lymph node dissection: Axillary lymph node dissection	No Axillary Dissection n=467 Participants Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment. No axillary lymph node dissection: Therapeutic conventional surgery	Total n=931 Participants Total of all reporting groups
Age, Continuous	53 years n=5 Participants	54 years n=7 Participants	54 years n=5 Participants
Sex: Female, Male Female	464 Participants n=5 Participants	467 Participants n=7 Participants	931 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: 5-year estimate reported after a median follow-up of 60 months

Population: Intention-to-treat

Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to first evidence of invasive relapse at any site, second primary tumor (contralateral or non-breast) or death.

Outcome measures

Measure	Axillary Dissection n=464 Participants Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment. Axillary lymph node dissection: Axillary lymph node dissection	No Axillary Dissection n=467 Participants Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment. No axillary lymph node dissection: Therapeutic conventional surgery
5-year Disease-Free Survival	84.4 percentage of participants	87.8 percentage of participants

SECONDARY outcome

Timeframe: 5-year estimate reported after a median follow-up of 60 months

Population: Intention-to-treat

Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death of any cause.

Outcome measures

Measure	Axillary Dissection n=464 Participants Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment. Axillary lymph node dissection: Axillary lymph node dissection	No Axillary Dissection n=467 Participants Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment. No axillary lymph node dissection: Therapeutic conventional surgery
5-year Overall Survival	97.6 percentage of participants	97.5 percentage of participants

SECONDARY outcome

Timeframe: Reported after a median follow-up of 60 months

Population: Intention-to-treat

Site of recurrence of breast cancer

Outcome measures

Measure	Axillary Dissection n=464 Participants Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment. Axillary lymph node dissection: Axillary lymph node dissection	No Axillary Dissection n=467 Participants Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment. No axillary lymph node dissection: Therapeutic conventional surgery
Site of Recurrence Local recurrence	10 participants	8 participants
Site of Recurrence Regional recurrence	1 participants	5 participants
Site of Recurrence Contralateral breast cancer	3 participants	9 participants
Site of Recurrence Distant recurrence	34 participants	25 participants
Site of Recurrence Second (non-breast) primary	20 participants	6 participants
Site of Recurrence Death without cancer event	1 participants	2 participants

Adverse Events

Axillary Dissection

Serious events: 1 serious events

Other events: 178 other events

Deaths: 0 deaths

No Axillary Dissection

Serious events: 0 serious events

Other events: 83 other events

Deaths: 0 deaths

Serious adverse events

Measure	Axillary Dissection n=447 participants at risk Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment. Axillary lymph node dissection: Axillary lymph node dissection	No Axillary Dissection n=453 participants at risk Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment. No axillary lymph node dissection: Therapeutic conventional surgery
Infections and infestations Post-operative infection (L.axilla)	0.22% 1/447 • 5-years. Treating physician assessed and reported long-term surgical events (sensory neuropathy, lymphoedema and motor neuropathy) at every follow-up visit (every 4 months from date of randomization for the first year and every six months from years 2-5). Analysis population excludes 31 patients (17 in Axillary Dissection group/14 in No Axillary Dissection group) who did not receive the randomly-assigned treatment.	0.00% 0/453 • 5-years. Treating physician assessed and reported long-term surgical events (sensory neuropathy, lymphoedema and motor neuropathy) at every follow-up visit (every 4 months from date of randomization for the first year and every six months from years 2-5). Analysis population excludes 31 patients (17 in Axillary Dissection group/14 in No Axillary Dissection group) who did not receive the randomly-assigned treatment.

Other adverse events

Measure	Axillary Dissection n=447 participants at risk Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment. Axillary lymph node dissection: Axillary lymph node dissection	No Axillary Dissection n=453 participants at risk Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment. No axillary lymph node dissection: Therapeutic conventional surgery
Nervous system disorders Sensory neuropathy	18.3% 82/447 • 5-years. Treating physician assessed and reported long-term surgical events (sensory neuropathy, lymphoedema and motor neuropathy) at every follow-up visit (every 4 months from date of randomization for the first year and every six months from years 2-5). Analysis population excludes 31 patients (17 in Axillary Dissection group/14 in No Axillary Dissection group) who did not receive the randomly-assigned treatment.	12.1% 55/453 • 5-years. Treating physician assessed and reported long-term surgical events (sensory neuropathy, lymphoedema and motor neuropathy) at every follow-up visit (every 4 months from date of randomization for the first year and every six months from years 2-5). Analysis population excludes 31 patients (17 in Axillary Dissection group/14 in No Axillary Dissection group) who did not receive the randomly-assigned treatment.
Vascular disorders Lymphedema	13.2% 59/447 • 5-years. Treating physician assessed and reported long-term surgical events (sensory neuropathy, lymphoedema and motor neuropathy) at every follow-up visit (every 4 months from date of randomization for the first year and every six months from years 2-5). Analysis population excludes 31 patients (17 in Axillary Dissection group/14 in No Axillary Dissection group) who did not receive the randomly-assigned treatment.	3.3% 15/453 • 5-years. Treating physician assessed and reported long-term surgical events (sensory neuropathy, lymphoedema and motor neuropathy) at every follow-up visit (every 4 months from date of randomization for the first year and every six months from years 2-5). Analysis population excludes 31 patients (17 in Axillary Dissection group/14 in No Axillary Dissection group) who did not receive the randomly-assigned treatment.
Nervous system disorders Motor neuropathy	8.3% 37/447 • 5-years. Treating physician assessed and reported long-term surgical events (sensory neuropathy, lymphoedema and motor neuropathy) at every follow-up visit (every 4 months from date of randomization for the first year and every six months from years 2-5). Analysis population excludes 31 patients (17 in Axillary Dissection group/14 in No Axillary Dissection group) who did not receive the randomly-assigned treatment.	2.9% 13/453 • 5-years. Treating physician assessed and reported long-term surgical events (sensory neuropathy, lymphoedema and motor neuropathy) at every follow-up visit (every 4 months from date of randomization for the first year and every six months from years 2-5). Analysis population excludes 31 patients (17 in Axillary Dissection group/14 in No Axillary Dissection group) who did not receive the randomly-assigned treatment.

Additional Information

Rudolf Maibach, Executive Officer for International Trial Activities

IBCSG

Phone: +41 31 389 91 96

Email: rudolf.maibach@ibcsg.org

Results disclosure agreements

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