Ketorolac in Breast Cancer Surgery

Phase 3

Completed

Conditions: Curative Breast Cancer Surgery
Inflammatory Positive/Negative Status
Pre Surgical Incision Administration

Interventions: Drug: Placebos
Drug: Ketorolac 30 mg IV

Registration Number: NCT01806259

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 203

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 )

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NaCl 0.9% 3mL	Placebos	Placebo looking like the Active drug
ketorolac 30 mg	Ketorolac 30 mg IV	Active drug to be compared with placebo

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures