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Ketorolac during breast cancer surgery

Phase 1
Conditions
Breast cancer
Therapeutic area: Diseases [C] - Cancer [C04]
Registration Number
EUCTR2012-003774-76-BE
Lead Sponsor
CUS
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Female
Target Recruitment
203
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

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).

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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