Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Evaluation of Cefazolin versus Placebo for Preventing Surgical Site Infection in Breast Cancer Lumpectomy Patients

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

The study looks at people with Breast Cancer who are having a lumpectomy (partial removal of the breast). It compares the antibiotic cefazolin given before surgery with a harmless solution (placebo). The purpose is to find out whether the antibiotic is needed to prevent infection after the operation.

Participants are randomly assigned to receive either the antibiotic or the placebo in a double‑blind way, meaning neither the patient nor the surgical team knows which one is given. The medication is given through an IV about one hour before the start of the lumpectomy. After surgery, patients stay in the hospital as usual and are followed for 30 days to see if any wound infection occurs.

During the follow‑up period, doctors check the surgical site for signs of infection, such as redness, swelling, or discharge, and record any additional treatments that may be needed. The study records any side effects from the medication or the placebo and notes any extra hospital time or readmissions. The overall aim is to compare infection rates between the two groups.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    You are asked to read information about the study and give written consent before any study procedures begin.

    The purpose of the study is to compare an antibiotic called cefazolin with a harmless solution (placebo) to see if the antibiotic is needed before breast lumpectomy.

  2. Step 2

    Baseline assessment

    Your medical history, current medications, and any allergies are recorded.

    Basic laboratory tests may be performed to ensure you are fit for surgery.

  3. Step 3

    Randomization

    You are assigned by a computer program to receive either the antibiotic cefazolin or a placebo solution.

    The assignment is double‑blind, meaning neither you nor the surgical team knows which product you receive.

  4. Step 4

    Administration of study medication

    Within one hour before the start of your lumpectomy, a single dose is given through an intravenous line.

    If you are assigned to the antibiotic group, you receive cefazolin 2 g (or 1 g, depending on the study formulation) dissolved for injection and given once.

    If you are assigned to the placebo group, you receive 100 ml of sterile sodium chloride solution (0.9 % saline) given once.

    The dose is administered only once, immediately before surgery.

  5. Step 5

    Lumpectomy surgery

    The breast‑conserving surgery (lumpectomy) is performed as planned.

    The surgical team follows standard procedures for removing the tumor and, if required, a sentinel lymph node sample.

  6. Step 6

    Post‑operative monitoring

    After surgery you remain in the hospital for routine observation.

    Healthcare staff check the surgical wound regularly for signs of a surgical site infection and monitor for any adverse reactions related to the study medication.

    Any problems are recorded and managed according to standard medical practice.

  7. Step 7

    Discharge and follow‑up visits

    You are discharged when the medical team determines it is safe.

    Scheduled follow‑up appointments are arranged, including a visit around day 30 after surgery to assess the wound for infection.

    During the follow‑up you will be asked about any symptoms, additional treatments, or hospital readmissions that may have occurred.

  8. Step 8

    Final assessment and study completion

    The study ends for you after the day‑30 evaluation, unless a serious complication requires further observation.

    All information collected during the trial is entered into the study database, and no further study‑specific procedures are required.

Who can join the trial?

6 criteria

  • Be at least 18 years old (an adult).
  • Be a woman.
  • Plan to have a breast lumpectomy or partial mastectomy, which means the surgeon will remove only the part of the breast that contains the tumor.
  • May also have a sentinel lymph node procedure, a test where a small nearby lymph node is removed to see if cancer has spread.
  • Be covered by a Social Security health system (the government program that provides health benefits).
  • Have signed the informed consent form, showing you understand the study and agree to take part.

Who cannot join the trial?

9 criteria

  • If you are having a breast lumpectomy or partial mastectomy and also a complete removal of the armpit (axillary) lymph nodes at the same time, you cannot join.
  • If you are known to be allergic (hypersensitivity) to cefazolin or other beta‑lactam antibiotics (a group of medicines that includes penicillin), you cannot join.
  • If you have extremely severe obesity, defined as a body‑mass index (BMI) higher than 50 kg/m², you cannot join.
  • If you have an active bacterial infection that is being treated with antibiotics, or if you have taken any antibiotics in the 15 days before surgery, you cannot join.
  • If you have severe weakening of your immune system (immunosuppression) or other strong risk factors for infection that would make your doctors decide to give you extra antibiotics outside the usual guidelines, you cannot join.
  • If you are already taking part in another study that is trying to reduce surgical infections, you cannot join.
  • If you have already been enrolled in this same study before, you cannot join.
  • If you are pregnant or breastfeeding, you cannot join.
  • If you are a minor, an adult under legal protection, or a person who is not free to make decisions (for example, detained), you cannot join.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Cefazolin is an antibiotic that is given through a vein right before the breast‑saving surgery (lumpectomy). Its purpose in the study is to prevent bacteria from causing an infection at the surgical site. Participants receive cefazolin or a harmless solution (placebo), and the trial checks whether the infection rate with the placebo is not higher than with the antibiotic.

What is already known about the treatment

  • Cefazolin sodium (2 g injection)

    This medication is given as a sterile solution that is injected into a vein about an hour before breast surgery. It is an established drug that is approved for use worldwide and is well described in medical research. Cefazolin is mainly used to prevent surgical infections and to treat mild to moderate infections caused by certain bacteria. It works by blocking the bacteria’s ability to build a protective cell wall and belongs to the first‑generation cephalosporin class of beta‑lactam antibiotics.

  • Cefazolin sodium (1 g injection)

    The drug is supplied as a powder that is reconstituted and administered intravenously, usually as a short infusion before the operation. It is a standard, approved antibiotic with extensive documentation in clinical literature. The main use is prophylaxis against infection during surgeries such as lumpectomy, and it can also treat uncomplicated bacterial infections. Its action is to interfere with bacterial cell‑wall synthesis, classifying it as a first‑generation cephalosporin beta‑lactam antibiotic.

Investigated diseases

Breast Cancer - Breast Cancer is a condition in which abnormal cells grow in the breast tissue. It often begins as a small lump that can be felt or seen on an image. Over time the cells may multiply and invade nearby tissue. The disease can spread from the original spot to surrounding areas such as the lymph nodes. As it advances, more of the breast and surrounding structures may be involved. The pattern of growth can vary from slow to faster expansion.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-525020-99-00Protocol codePHRC 2024 GARNIEREstimated enrolment1 600 patientsSponsorUniversity Hospital Of Clermont-Ferrand

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.