Phase 3 Completed N=203 Randomized Quadruple-blind Treatment

Ketorolac in Breast Cancer Surgery

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

Source: ClinicalTrials.gov NCT01806259 ↗

Enrolled (actual)

203

Serious AEs

7.4%

Results posted

Jan 2020

Primary outcomePrimary: Recurrence-free Survival — 80; 96 Participants

◆ Published Evidence

Established

26citations · ~4 / year

Intraoperative ketorolac in high-risk breast cancer patients. A prospective, randomized, placebo-controlled clinical trial.

PloS one · 2019 · Open access · Likely link

Full text ↗ PubMed 31800611 ↗ +1 more ↓

Summary

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.

Linked Publications (2)

Intraoperative ketorolac in high-risk breast cancer patients. A prospective, randomized, placebo-controlled clinical trial.

PloS one · 2019 · 26 citations · Open access · Likely link

Full text ↗PubMed 31800611 ↗
Perioperative ketorolac in high risk breast cancer patients. Rationale, feasibility and methodology of a prospective randomized placebo-controlled trial.

Medical hypotheses · 2013 · 25 citations · Likely link

Full text ↗PubMed 23937996 ↗

Outcome Measures

Outcome	Result	p-value
PRIMARY Recurrence-free Survival	80; 96	—

Eligibility Criteria

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 )

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01806259) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.