Ketorolac in Breast Cancer Surgery (KBCt)

Université Catholique de Louvain

Status and phase: Completed; Phase 3

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

Treatments: Drug: Placebos; Drug: Ketorolac 30 mg IV

Study type: Interventional

Funder types: Other

Identifiers

NCT01806259

KBCtrial

Details and patient eligibility

About

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.

Enrollment: 203 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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 )

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

203 participants in 2 patient groups, including a placebo group

ketorolac 30 mg

Experimental group

Description:

Active drug to be compared with placebo

Treatment:

Drug: Ketorolac 30 mg IV

NaCl 0.9% 3mL

Placebo Comparator group

Description:

Placebo looking like the Active drug

Treatment:

Drug: Placebos