Trial Outcomes & Findings for Surgical Breast Resection With or Without Axillary Lymph Node Excision in Treating Women With Breast Cancer (NCT NCT00210236)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

625 participants

Primary outcome timeframe

Five years after surgery

Results posted on

2025-10-17

Participant Flow

Participant milestones

Participant milestones
Measure	Conventional Surgery WITH Axillary Lymph Node Excision Tumorectomy or mastectomy, WITH Axillary Lymph Node Excision Conventional surgery WITH Axillary Lymph Node Excision	Conventional Surgery WITHOUT Axillary Lymph Node Excision Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision Conventional surgery WITHOUT Axillary Lymph Node Excision: Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision
Overall Study STARTED	313	312
Overall Study COMPLETED	313	312
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conventional Surgery WITH Axillary Lymph Node Excision n=313 Participants Tumorectomy or mastectomy, WITH Axillary Lymph Node Excision Conventional surgery WITH Axillary Lymph Node Excision	Conventional Surgery WITHOUT Axillary Lymph Node Excision n=312 Participants Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision Conventional surgery WITHOUT Axillary Lymph Node Excision: Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision	Total n=625 Participants Total of all reporting groups
Age, Continuous	62.9 years STANDARD_DEVIATION 7.2 • n=313 Participants	62.9 years STANDARD_DEVIATION 7.0 • n=312 Participants	62.9 years STANDARD_DEVIATION 7.0 • n=625 Participants
Sex: Female, Male Female	313 Participants n=313 Participants	312 Participants n=312 Participants	625 Participants n=625 Participants
Sex: Female, Male Male	0 Participants n=313 Participants	0 Participants n=312 Participants	0 Participants n=625 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	313 participants n=313 Participants	312 participants n=312 Participants	625 participants n=625 Participants

PRIMARY outcome

Timeframe: Five years after surgery

Population: Per protocol population. The following patients were excluded from the PP population : * patients who did not satisfy eligibility criteria * patients who did receive the intervention as allocated by the randomization.

Outcome measures

Outcome measures
Measure	Conventional Surgery WITH Axillary Lymph Node Excision n=310 Participants Tumorectomy or mastectomy, WITH Axillary Lymph Node Excision Conventional surgery WITH Axillary Lymph Node Excision	Conventional Surgery WITHOUT Axillary Lymph Node Excision n=297 Participants Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision Conventional surgery WITHOUT Axillary Lymph Node Excision: Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision
Number of Deaths	6 Participants	17 Participants

SECONDARY outcome

Timeframe: Five years after surgery

Proportion of participants with axiallary recurrence. Axillary (Regional) recurrence is defined as tumor recurrence in lymph nodes draining the primary tumor site, namely, nodes in the ipsilateral axilla, infraclavicular fossa, supraclavicular fossa and interpectoral area.

Outcome measures

Outcome measures
Measure	Conventional Surgery WITH Axillary Lymph Node Excision n=310 Participants Tumorectomy or mastectomy, WITH Axillary Lymph Node Excision Conventional surgery WITH Axillary Lymph Node Excision	Conventional Surgery WITHOUT Axillary Lymph Node Excision n=297 Participants Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision Conventional surgery WITHOUT Axillary Lymph Node Excision: Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision
Rate of Axillary Recurrence	0 Participants	7 Participants

Adverse Events

Conventional Surgery WITH Axillary Lymph Node Excision

Serious events: 0 serious events

Other events: 0 other events

Deaths: 10 deaths

Conventional Surgery WITHOUT Axillary Lymph Node Excision

Serious events: 0 serious events

Other events: 0 other events

Deaths: 24 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Simone Mathoulin-Palissier, Director of Clinical Trials Unit

Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR

Phone: +33 5 56 33 33 33

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place