Trial · NCT01806259
Ketorolac in Breast Cancer Surgery
NCT01806259, Phase 3, Completed, Université Catholique de Louvain; results first posted 2020-01-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ketorolac in Breast Cancer Surgery. Trials, record NCT01806259. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01806259
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ketorolac in Breast Cancer Surgery
- NCT number
- NCT01806259
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 203 participants, actual
- Lead sponsor
- Université Catholique de Louvain
- Conditions
- Curative Breast Cancer Surgery, Inflammatory Positive/Negative Status, Pre Surgical Incision Administration
- Interventions
- Ketorolac 30 mg IV, Placebos
- First posted
- 2013-03-07
- Last updated
- 2020-04-07
- Results first posted
- 2020-01-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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) |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recurrence-free Survival | 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Overall Survival | 5 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Recurrence-free Survival | Ketorolac 30 mg | 80 | Participants | ||
| Recurrence-free Survival | NaCl 0.9% 3mL | 96 | Participants | ||
| Overall Survival | Ketorolac 30 mg | 93 | Participants | ||
| Overall Survival | NaCl 0.9% 3mL | 105 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ketorolac 30 mg | 96 | |
| Overall Study | STARTED | NaCl 0.9% 3mL | 107 | |
| Overall Study | COMPLETED | Ketorolac 30 mg | 96 | |
| Overall Study | COMPLETED | NaCl 0.9% 3mL | 107 | |
| Overall Study | NOT COMPLETED | Ketorolac 30 mg | 0 | |
| Overall Study | NOT COMPLETED | NaCl 0.9% 3mL | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Any type (not bleeding related) | General disorders | Ketorolac 30 mg | 7 | 96 | 7 |
| serious | Any type (not bleeding related) | General disorders | NaCl 0.9% 3mL | 7 | 107 | 7 |
| serious | Hematoma requiring surgery | Blood and lymphatic system disorders | Ketorolac 30 mg | 1 | 96 | 1 |
| serious | Hematoma requiring surgery | Blood and lymphatic system disorders | NaCl 0.9% 3mL | 0 | 107 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ketorolac 30 mg | ||
| Total, all-cause mortality | NaCl 0.9% 3mL | ||
| Total, other adverse events | Ketorolac 30 mg | 0 | 96 |
| Total, other adverse events | NaCl 0.9% 3mL | 0 | 107 |
| Total, serious adverse events | Ketorolac 30 mg | 8 | 96 |
| Total, serious adverse events | NaCl 0.9% 3mL | 7 | 107 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ketorolac 30 mg vs NaCl 0.9% 3mL: Recurrence-free Survival | Trial comparisons |
| Ketorolac 30 mg vs NaCl 0.9% 3mL: Overall Survival | Trial comparisons |
| Ketorolac 30 mg vs NaCl 0.9% 3mL: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01806259
GET https://conductscience.org/api/trials/v1/NCT01806259/registered