Curative Breast Cancer Surgery, Inflammatory Positive/Negative Status, Pre Surgical Incision Administration
Conditions
Brief summary
Do the use of Ketorolac in one intravenous injection at the moment of the operative incision reduce the number of recurrence in patient with advanced breast cancer without inflammation signs.
Interventions
Active drug
DRUGPlacebos
Placebo looking like the Active drug
Sponsors
Anticancer Fund, Belgium
Université Catholique de Louvain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Written informed Consent age : 18-85 years weight: 50-100 kg Neutrophils / Lymphocytes ratio \>4 and/or triple negative histological status and/or Positive lymph nodes
Exclusion criteria
Previous cancer (behalf of basocellular skin cancer and in situ uterine cervix cancer) Non compliance or refusal of the protocol Positive Pregnancy test Childbearing or breastfeeding mothers Contra-indication for NSAIDs NSAIDs intake in the 5 days before randomisation NSAIDs use planned in the 30 days after randomisation Non curative surgery (T4 or M1 tumor classification )
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-free Survival | 5 years | 2 years for the primary analysis + 3 additional years for secondary analysis (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 5 years | 2 years for the primary analysis + 3 additional years for secondary analysis (From date of randomization until the date of death from any cause assessed up to 5 years) |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketorolac 30 mg Active drug to be compared with placebo
Ketorolac 30 mg IV | 96 |
| NaCl 0.9% 3mL Ketorolac 30 mg IV | 107 |
| Total | 203 |
Baseline characteristics
| Characteristic | Ketorolac 30 mg | NaCl 0.9% 3mL | Total |
|---|---|---|---|
| Age, Continuous | 56.1 years STANDARD_DEVIATION 14 | 55.4 years STANDARD_DEVIATION 13.9 | 55.7 years STANDARD_DEVIATION 14 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 95 Participants | 107 Participants | 202 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 96 | 0 / 107 |
| serious Total, serious adverse events | 8 / 96 | 7 / 107 |
Outcome results
Primary
Recurrence-free Survival
2 years for the primary analysis + 3 additional years for secondary analysis (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ketorolac 30 mg | Recurrence-free Survival | 80 Participants |
| NaCl 0.9% 3mL | Recurrence-free Survival | 96 Participants |
Other Pre-specified
Overall Survival
2 years for the primary analysis + 3 additional years for secondary analysis (From date of randomization until the date of death from any cause assessed up to 5 years)
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ketorolac 30 mg | Overall Survival | 93 Participants |
| NaCl 0.9% 3mL | Overall Survival | 105 Participants |