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Ketorolac in Breast Cancer Surgery (KBCt)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01806259
Recruitment Status : Completed
First Posted : March 7, 2013
Results First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Anticancer Fund, Belgium
Information provided by (Responsible Party):
Patrice Forget, Université Catholique de Louvain

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.

Condition or disease Intervention/treatment Phase
Curative Breast Cancer Surgery Inflammatory Positive/Negative Status Pre Surgical Incision Administration Drug: Ketorolac 30 mg IV Phase 3

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Ketorolac

Arm Intervention/treatment
Experimental: ketorolac 30 mg
Active drug to be compared with placebo
Drug: Ketorolac 30 mg IV
Placebo Comparator: NaCl 0.9% 3mL Drug: Ketorolac 30 mg IV

Primary Outcome Measures :
  1. Effect of Ketorolac on 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)

Other Outcome Measures:
  1. Effect of Ketorolac on Overall Survival [ Time Frame: 5 years ]
    (From date of randomization until the date of death from any cause assessed up to 5 years)

Information from the National Library of Medicine

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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 )

Information from the National Library of Medicine

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 identifier (NCT number): NCT01806259

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Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Université Catholique de Louvain
Anticancer Fund, Belgium
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Principal Investigator: Patrice Forget, MD Cliniques universitaires Saint-Luc

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Patrice Forget, Docteur, Université Catholique de Louvain Identifier: NCT01806259    
Other Study ID Numbers: KBCtrial
First Posted: March 7, 2013    Key Record Dates
Results First Posted: January 18, 2020
Last Update Posted: January 18, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Breast Neoplasms
Surgical Wound
Neoplasms by Site
Breast Diseases
Skin Diseases
Wounds and Injuries
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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