Ketorolac in Breast Cancer Surgery

Université Catholique de Louvain203 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

203

Conditions

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

Interventions

Ketorolac 30 mg IVDRUG

Active drug

PlacebosDRUG

Placebo looking like the Active drug

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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 )

Locations (1)

Cliniques universitaires Saint-Luc

Brussels, Belgium

Outcomes

Primary Outcomes

Recurrence-free Survival

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

Data from ClinicalTrials.gov

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