Breast Cancer
Conditions
Keywords
Breast neoplasms, Local recurrence, Survival, Surgery
Brief summary
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
Detailed description
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.
Interventions
PROCEDUREConventional surgery WITHOUT Axillary Lymph Node Excision
Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision
PROCEDUREConventional surgery WITH Axillary Lymph Node Excision
Sponsors
Institut Bergonié
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Deaths | Five years after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Axillary Recurrence | 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conventional Surgery WITH Axillary Lymph Node Excision Tumorectomy or mastectomy, WITH Axillary Lymph Node Excision
Conventional surgery WITH Axillary Lymph Node Excision | 313 |
| 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 | 312 |
| Total | 625 |
Baseline characteristics
| Characteristic | Conventional Surgery WITHOUT Axillary Lymph Node Excision | Total | Conventional Surgery WITH Axillary Lymph Node Excision |
|---|---|---|---|
| Age, Continuous | 62.9 years STANDARD_DEVIATION 7 | 62.9 years STANDARD_DEVIATION 7 | 62.9 years STANDARD_DEVIATION 7.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment France | 312 participants | 625 participants | 313 participants |
| Sex: Female, Male Female | 312 Participants | 625 Participants | 313 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 10 / 313 | 24 / 312 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Deaths
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conventional Surgery WITH Axillary Lymph Node Excision | Number of Deaths | 6 Participants |
| Conventional Surgery WITHOUT Axillary Lymph Node Excision | Number of Deaths | 17 Participants |
p-value: 0.01395% CI: [1.4, 6.7]Log Rank
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conventional Surgery WITH Axillary Lymph Node Excision | Rate of Axillary Recurrence | 0 Participants |
| Conventional Surgery WITHOUT Axillary Lymph Node Excision | Rate of Axillary Recurrence | 7 Participants |