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


Phase 3
18 Years
85 Years
Open (Enrolling)
Both
Curative Breast Cancer Surgery, Inflammatory Positive/Negative Status, Pre Surgical Incision Administration

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Trial Information

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


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 )

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Effect of ketorolac on recurrence-free survival

Outcome Description:

2 years for the primary analysis + 3 additional years for secondary analysis

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Patrice Forget, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cliniques universitaires Saint-Luc

Authority:

Europe : EMEA

Study ID:

KBCtrial

NCT ID:

NCT01806259

Start Date:

February 2013

Completion Date:

March 2018

Related Keywords:

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

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