Ketorolac in Breast Cancer Surgery (KBCt)
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ClinicalTrials.gov Identifier: NCT01806259 |
Recruitment Status :
Completed
First Posted : March 7, 2013
Results First Posted : January 18, 2020
Last Update Posted : April 7, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Curative Breast Cancer Surgery Inflammatory Positive/Negative Status Pre Surgical Incision Administration | Drug: Ketorolac 30 mg IV Drug: Placebos | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 203 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Perioperative Ketorolac in High Risk Breast Cancer Patients With and Without Inflammation. A Prospective Randomized Placebo-controlled Trial. |
Actual Study Start Date : | February 2013 |
Actual Primary Completion Date : | October 2015 |
Actual Study Completion Date : | September 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: ketorolac 30 mg
Active drug to be compared with placebo
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Drug: Ketorolac 30 mg IV
Active drug
Other Name: ketorolac tromethamine |
Placebo Comparator: NaCl 0.9% 3mL
Placebo looking like the Active drug
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Drug: Placebos
Placebo looking like the Active drug
Other Name: NaCl 0.9% |
- Recurrence-free Survival [ Time Frame: 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)
- Overall Survival [ Time Frame: 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)

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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 )

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806259
Belgium | |
Cliniques universitaires Saint-Luc | |
Brussels, Belgium, 1200 |
Principal Investigator: | Patrice Forget, MD | Cliniques universitaires Saint-Luc |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Patrice Forget, Docteur, Université Catholique de Louvain |
ClinicalTrials.gov Identifier: | NCT01806259 |
Other Study ID Numbers: |
KBCtrial |
First Posted: | March 7, 2013 Key Record Dates |
Results First Posted: | January 18, 2020 |
Last Update Posted: | April 7, 2020 |
Last Verified: | March 2020 |
Breast Neoplasms Surgical Wound Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Wounds and Injuries Ketorolac Ketorolac Tromethamine Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |