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OpenTrials
Completed

NCT Number: NCT01806259

Ketorolac in Breast Cancer Surgery

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

Ketorolac 30 mg IV

Drug

Active drug

Other names: ketorolac tromethamine

Placebos

Drug

Placebo looking like the Active drug

Other names: NaCl 0.9%

Primary outcomes

  1. Recurrence-free Survival

    Time frame: 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 outcomes

  1. Overall Survival

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Collaborators

  • Anticancer Fund, Belgium

Registry information

Official study title

Perioperative Ketorolac in High Risk Breast Cancer Patients With and Without Inflammation. A Prospective Randomized Placebo-controlled Trial.

Acronym: KBCt

Important dates

Study start
2013
Primary completion
2015
Study completion
2018
First posted
Mar 7, 2013
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.