Ketorolac during breast cancer surgery

Perioperative ketorolac in high risk breast cancer patients with and without inflammation. A prospective randomized placebo-controlled trial. - KBC-trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003774-76-BE

Enrollment

200

Registered

2012-09-11

Start date

2012-10-09

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Trade Name: Taradyl Pharmaceutical Form: Solution for injection INN or Proposed INN: KETOROLAC CAS Number: 74103-06-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Invasive Breast cancer with high risk of recurrence (presence of preop inflammation, triple negative histological status, lymph node invasion) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: Patients will be excluded if refusing or not able to follow any part of the protocol (preoperative screening, complete treatment or follow-up), in the case of history of cancer (from the breast of any another) in the past 2 years, in the case of planned non-curative surgery (preoperative confirmed T4 or M1 stage) and if the presence of a contraindication for ketorolac (or another of the drugs used in the standardized anesthetic protocol).

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Overall survival will be considered as a secondary endpoint. Other subgroup analyses are possible.;Primary end point(s): Consequently, our primary endpoint for this analysis was the metastasis-free survival time. ;Timepoint(s) of evaluation of this end point: The follow-up will be performed by the oncologist in charge of the patients, typically each 3 month after the surgery, and each 6 month after the first postoperative year. ;Main Objective: Our primary objective will be to investigate the effect of perioperative ketorolac on cancer recurrence rate in high risk patients.	—

Measure

Time frame

Secondary Objective: Overall survival will be considered as a secondary endpoint. Other subgroup analyses are possible.;Primary end point(s): Consequently, our primary endpoint for this analysis was the metastasis-free survival time. ;Timepoint(s) of evaluation of this end point: The follow-up will be performed by the oncologist in charge of the patients, typically each 3 month after the surgery, and each 6 month after the first postoperative year. ;Main Objective: Our primary objective will be to investigate the effect of perioperative ketorolac on cancer recurrence rate in high risk patients.

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Secondary

Measure	Time frame
Secondary end point(s): Overall survival will be considered as a secondary endpoint. Metastasis-free survival time will be measured from the date of surgery to the date of first recurrence or the date of last follow-up if metastasis-free at the end of follow-up.;Timepoint(s) of evaluation of this end point: The follow-up will be performed by the oncologist in charge of the patients, typically each 3 month after the surgery, and each 6 month after the first postoperative year.	—

Measure

Time frame

Secondary end point(s): Overall survival will be considered as a secondary endpoint. Metastasis-free survival time will be measured from the date of surgery to the date of first recurrence or the date of last follow-up if metastasis-free at the end of follow-up.;Timepoint(s) of evaluation of this end point: The follow-up will be performed by the oncologist in charge of the patients, typically each 3 month after the surgery, and each 6 month after the first postoperative year.

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Countries

Belgium

Contacts

Public ContactDpt of Anesthesiology

CUSL

forgetpatrice@yahoo.fr

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 1, 2026