A Phase 3 interventional study of Conventional surgery WITHOUT Axillary Lymph Node Excision and Conventional surgery WITH Axillary Lymph Node Excision in Breast Cancer, sponsored by Institut Bergonié. Terminated at 14 sites in France. Open to female participants aged 50 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-10-20.
Sponsored by Institut Bergonié · Phase 3, Interventional, and Treatment
This randomized phase III trial is studying surgery and axillary lymph node dissection to evaluate if systematic Axillary Lymph Node Excision can be avoided in locoregional treatment for operable breast cancer smaller than 10 mm among menopausal women older than 50
Phase III randomized multicenter equivalence trial evaluating the role of Axillary Lymph Node Excision.
Primary aim is to assess if it is possible to avoid routine Axillary Lymph Node Excision during the initial treatment of breast cancers smaller than 11 mm in women aged 50 and older without compromising survival? The primary endpoint is overall survival: the event considered will be death from any cause.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 625 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Institut Bergonié is the lead sponsor of 119 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women, 50 year or more Menopausal women Breast cancer Macroscopic tumor size of 10 mm or less (measured during operation) No palpable axillary node ( N0)
Exclusion criteria:
Previous cancer history life expectancy \< 10 years Metastasis
Tumorectomy or mastectomy, WITH Axillary Lymph Node Excision
Procedure: Conventional surgery WITH Axillary Lymph Node Excision
Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision
Procedure: Conventional surgery WITHOUT Axillary Lymph Node Excision
Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision
Also known as: Tumorectomy or mastectomy, WITH Axillary Lymph Node Excision
Number of Deaths
Time frame: Five years after surgery
Rate of Axillary Recurrence
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.
Time frame: Five years after surgery
| Milestone | Conventional Surgery WITH Axillary Lymph Node Excision | Conventional Surgery WITHOUT Axillary Lymph Node Excision |
|---|---|---|
| Started | 313 | 312 |
| Completed | 313 | 312 |
| Not completed | 0 | 0 |
| Participants | Conventional Surgery WITH Axillary Lymph Node Excision | Conventional Surgery WITHOUT Axillary Lymph Node Excision |
|---|---|---|
| Number of Deaths | 6 | 17 |
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.
| Participants | Conventional Surgery WITH Axillary Lymph Node Excision | Conventional Surgery WITHOUT Axillary Lymph Node Excision |
|---|---|---|
| Rate of Axillary Recurrence | 0 | 7 |
Collected over 10 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Conventional Surgery WITH Axillary Lymph Node Excision | 10/313 (3.2%) | — | — |
| Conventional Surgery WITHOUT Axillary Lymph Node Excision | 24/312 (7.7%) | — | — |
| Age, Continuous(years) | Conventional Surgery WITH Axillary Lymph Node Excision | Conventional Surgery WITHOUT Axillary Lymph Node Excision | Total |
|---|---|---|---|
| Mean | 62.9 ± 7.2 | 62.9 ± 7.0 | 62.9 ± 7.0 |
| Sex: Female, Male(Participants) | Conventional Surgery WITH Axillary Lymph Node Excision | Conventional Surgery WITHOUT Axillary Lymph Node Excision | Total |
|---|---|---|---|
| Female | 313 | 312 | 625 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Conventional Surgery WITH Axillary Lymph Node Excision | Conventional Surgery WITHOUT Axillary Lymph Node Excision | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Conventional Surgery WITH Axillary Lymph Node Excision | Conventional Surgery WITHOUT Axillary Lymph Node Excision | Total |
|---|---|---|---|
| France | 313 | 312 | 625 |
Plan to share: No
This study is terminated, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Institut Bergonié