KBCt: Ketorolac in Breast Cancer Surgery

• Sponsor: Université Catholique de Louvain (Other)
• Overall Status: Completed
• CT.gov ID: NCT01806259
• Collaborator: Anticancer Fund, Belgium (Other)
• Enrollment: 203
• Location: 1
• Arms: 2
• Actual Duration (Months): 67
• Patients Per Site Per Month: 3

Study Details

Study Description

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; Drug: Placebos	Phase 3

Study Design

• Study Type: Interventional
• 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: Feb 1, 2013
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Sep 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ketorolac 30 mg Active drug to be compared with placebo	Drug: Ketorolac 30 mg IV; Active drug; Other Names: ketorolac tromethamine
Placebo Comparator: NaCl 0.9% 3mL Placebo looking like the Active drug	Drug: Placebos; Placebo looking like the Active drug; Other Names: NaCl 0.9%

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• 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 )

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cliniques universitaires Saint-Luc	Brussels		Belgium	1200

Sponsors and Collaborators

• Université Catholique de Louvain
• Anticancer Fund, Belgium

Investigators

• Principal Investigator: Patrice Forget, MD, Cliniques universitaires Saint-Luc

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

• Forget 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.

• Responsible Party: Patrice Forget, Docteur, Université Catholique de Louvain
• ClinicalTrials.gov Identifier: NCT01806259
• Other Study ID Numbers: KBCtrial
• First Posted: Mar 7, 2013
• Last Update Posted: Apr 7, 2020
• Last Verified: Mar 1, 2020

• Additional relevant MeSH terms: Breast Neoplasms; Surgical Wound; Ketorolac; Ketorolac Tromethamine

Study Results

Participant Flow

Arm/Group Title	Ketorolac 30 mg	NaCl 0.9% 3mL
Arm/Group Description	Active drug to be compared with placebo Ketorolac 30 mg IV	Placebo
Period Title: Overall Study
STARTED	96	107
COMPLETED	96	107
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Ketorolac 30 mg	NaCl 0.9% 3mL	Total
Arm/Group Description	Active drug to be compared with placebo Ketorolac 30 mg IV	Ketorolac 30 mg IV	Total of all reporting groups
Overall Participants	96	107	203
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.1 (14)	55.4 (13.9)	55.7 (14)
Sex: Female, Male (Count of Participants)
Female	95 99%	107 100%	202 99.5%
Male	1 1%	0 0%	1 0.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Recurrence-free Survival
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ketorolac 30 mg	NaCl 0.9% 3mL
Arm/Group Description	Active drug to be compared with placebo Ketorolac 30 mg IV	Ketorolac 30 mg IV
Measure Participants	96	107
Count of Participants [Participants]	80 83.3%	96 89.7%

2. Other Pre-specified Outcome

Title	Overall Survival
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ketorolac 30 mg	NaCl 0.9% 3mL
Arm/Group Description	Active drug to be compared with placebo Ketorolac 30 mg IV	Placebo looking like the Active drug
Measure Participants	96	107
Count of Participants [Participants]	93 96.9%	105 98.1%

Adverse Events

Arm/Group Title	Ketorolac 30 mg		NaCl 0.9% 3mL
Arm/Group Description	Active drug to be compared with placebo Ketorolac 30 mg IV		Placebo looking like the Active drug
All Cause Mortality
	Ketorolac 30 mg		NaCl 0.9% 3mL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ketorolac 30 mg		NaCl 0.9% 3mL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/96 (8.3%)		7/107 (6.5%)
Blood and lymphatic system disorders
Hematoma requiring surgery	1/96 (1%)	1	0/107 (0%)	0
General disorders
Any type (not bleeding related)	7/96 (7.3%)	7	7/107 (6.5%)	7
Other (Not Including Serious) Adverse Events
	Ketorolac 30 mg		NaCl 0.9% 3mL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/96 (0%)		0/107 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.