Clinical trial · Interventional
Ketorolac in Breast Cancer Surgery
Perioperative Ketorolac in High Risk Breast Cancer Patients With and Without Inflammation. A Prospective Randomized Placebo-controlled Trial.
NCT01806259CI-TRIAL-00044529KBCtcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Curative Breast Cancer Surgery | — | UNRESOLVED | — |
| Inflammatory Positive/Negative Status | — | UNRESOLVED | — |
| Pre Surgical Incision Administration | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ketorolac 30 mg IV | Drug | — | UNRESOLVED |
| Placebos | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ketorolac 30 mg
- description
- Active drug to be compared with placebo
- interventionNames
- Drug: Ketorolac 30 mg IV
- type
- PLACEBO_COMPARATOR
- label
- NaCl 0.9% 3mL
- description
- Placebo looking like the Active drug
- interventionNames
- Drug: Placebos
Primary outcomes (1)
- measure
- Recurrence-free Survival
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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 )
References
Publications (3)
- BACKGROUNDForget P, Vandenhende J, Berliere M, Machiels JP, Nussbaum B, Legrand C, De Kock M. Do intraoperative analgesics influence breast cancer recurrence after mastectomy? A retrospective analysis. Anesth Analg. 2010 Jun 1;110(6):1630-5. doi: 10.1213/ANE.0b013e3181d2ad07. Epub 2010 Apr 30. PMID 20435950
- DERIVEDForget P, Bouche G, Duhoux FP, Coulie PG, Decloedt J, Dekleermaker A, Guillaume JE, Ledent M, Machiels JP, Mustin V, Swinnen W, van Maanen A, Vander Essen L, Verougstraete JC, De Kock M, Berliere M. Intraoperative ketorolac in high-risk breast cancer patients. A prospective, randomized, placebo-controlled clinical trial. PLoS One. 2019 Dec 4;14(12):e0225748. doi: 10.1371/journal.pone.0225748. eCollection 2019. PMID 31800611
- DERIVEDForget P, Berliere M, van Maanen A, Duhoux FP, Machiels JP, Coulie PG, Bouche G, De Kock M; Ketorolac in Breast Cancer trial (KBCtrial) group. Perioperative ketorolac in high risk breast cancer patients. Rationale, feasibility and methodology of a prospective randomized placebo-controlled trial. Med Hypotheses. 2013 Oct;81(4):707-12. doi: 10.1016/j.mehy.2013.07.033. Epub 2013 Aug 9. PMID 23937996