Trial Outcomes & Findings for Ketorolac in Breast Cancer Surgery (NCT NCT01806259)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

203 participants

Primary outcome timeframe

5 years

Results posted on

2020-04-07

Participant Flow

Participant milestones

Participant milestones
Measure	Ketorolac 30 mg Active drug to be compared with placebo Ketorolac 30 mg IV	NaCl 0.9% 3mL Placebo
Overall Study STARTED	96	107
Overall Study COMPLETED	96	107
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketorolac 30 mg n=96 Participants Active drug to be compared with placebo Ketorolac 30 mg IV	NaCl 0.9% 3mL n=107 Participants Ketorolac 30 mg IV	Total n=203 Participants Total of all reporting groups
Age, Continuous	56.1 years STANDARD_DEVIATION 14 • n=96 Participants	55.4 years STANDARD_DEVIATION 13.9 • n=107 Participants	55.7 years STANDARD_DEVIATION 14 • n=203 Participants
Sex: Female, Male Female	95 Participants n=96 Participants	107 Participants n=107 Participants	202 Participants n=203 Participants
Sex: Female, Male Male	1 Participants n=96 Participants	0 Participants n=107 Participants	1 Participants n=203 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Ketorolac 30 mg n=96 Participants Active drug to be compared with placebo Ketorolac 30 mg IV	NaCl 0.9% 3mL n=107 Participants Ketorolac 30 mg IV
Recurrence-free Survival	80 Participants	96 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Ketorolac 30 mg n=96 Participants Active drug to be compared with placebo Ketorolac 30 mg IV	NaCl 0.9% 3mL n=107 Participants Ketorolac 30 mg IV
Overall Survival	93 Participants	105 Participants

Adverse Events

Ketorolac 30 mg

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

NaCl 0.9% 3mL

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ketorolac 30 mg n=96 participants at risk Active drug to be compared with placebo Ketorolac 30 mg IV	NaCl 0.9% 3mL n=107 participants at risk Placebo looking like the Active drug
General disorders Any type (not bleeding related)	7.3% 7/96 • Number of events 7	6.5% 7/107 • Number of events 7
Blood and lymphatic system disorders Hematoma requiring surgery	1.0% 1/96 • Number of events 1	0.00% 0/107

Other adverse events

Adverse event data not reported

Additional Information

Prof Patrice Forget

UoA

Phone: 497 12 28 36

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place