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Carboplatin drug combination as neoadjuvant therapy for early stage II triple‑negative breast cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

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

The study focuses on patients with early triple-negative breast cancer that is classified as stage II. The treatment being tested combines two chemotherapy medicines, CARBOPLATIN and PACLITAXEL, with an immunotherapy drug called pembrolizumab. All three medicines are given by an IV infusion, meaning they are delivered directly into a vein, and the regimen consists of four treatment cycles spread over about twelve weeks before any surgery is performed.

The primary goal of the trial is to see how well this combination can eliminate detectable tumor before surgery. After the twelve‑week treatment period, participants undergo a breast scan using MRI and a small tissue sample (biopsy) to check for any remaining cancer. If no tumor is found, surgery follows as usual, and the participants continue to be monitored for several years to track overall health, any return of disease, and side effects.

During the study, researchers also record information about how patients feel, including quality of life and worries about cancer coming back, as well as any side effects from the medicines. Tissue from the tumor may be examined in the laboratory to learn more about the disease and how it responds to the treatment.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessments

    After enrollment, an initial breast mri and a tissue biopsy are performed to confirm the presence of cancer and to measure tumor‑infiltrating lymphocytes.

    Questionnaires about quality of life and fear of recurrence are completed.

    Blood samples are taken to check organ function before starting medication.

  2. Step 2

    First treatment cycle

    On day 1 you receive an intravenous infusion of carboplatin 800 mg, followed by paclitaxel 160 mg, and pembrolizumab 200 mg.

    The infusion is given through a vein over several minutes as directed by medical staff.

    This cycle is repeated every three weeks for a total of four cycles.

  3. Step 3

    Second treatment cycle

    Three weeks after the first cycle you receive the same three medicines at the same doses: carboplatin 800 mg, paclitaxel 160 mg, and pembrolizumab 200 mg, administered by intravenous infusion.

    The same monitoring procedures are followed.

  4. Step 4

    Third treatment cycle

    Another three weeks later you receive the third round of carboplatin 800 mg, paclitaxel 160 mg, and pembrolizumab 200 mg, delivered by intravenous infusion.

    Any side effects are assessed before the next dose.

  5. Step 5

    Fourth treatment cycle

    The final cycle, given three weeks after the third, includes the same doses of carboplatin 800 mg, paclitaxel 160 mg, and pembrolizumab 200 mg, delivered by intravenous infusion.

    After this infusion the 12‑week neoadjuvant treatment period ends.

  6. Step 6

    Post‑treatment evaluation

    Within a short period after the fourth cycle, a repeat breast mri and a new biopsy are performed to evaluate whether any tumor remains.

    The results determine the pathological response before surgery.

  7. Step 7

    Surgery

    Based on the evaluation, surgery is scheduled to remove the breast tumor and nearby lymph nodes.

    The surgical specimen is examined to confirm the final response.

  8. Step 8

    Post‑surgery follow‑up

    Three months after surgery you complete the quality‑of‑life questionnaire (eortc qlq‑c30) and the health‑status questionnaire (eq‑5d‑5l).

    The fear‑of‑recurrence questionnaire (fcri‑sf) is also completed.

    Blood tests and physical examinations are performed to monitor for any signs of disease.

  9. Step 9

    Long‑term follow‑up

    Regular visits are scheduled for up to three years after surgery.

    At each visit the same questionnaires are repeated, and the doctor checks for disease recurrence, overall survival, and any late side effects.

    Event‑free survival and overall survival are recorded from the date of enrollment.

Who can join the trial?

21 criteria

  • Must be at least 18 years old, and can be male or female.
  • Must have a confirmed diagnosis of invasive triple‑negative breast cancer, meaning the cancer cells do not have estrogen receptors (ER), progesterone receptors (PR), or HER2 proteins; this confirmation is done by looking at the cells under a microscope.
  • Cancer must be classified as stage II, which means the tumor size and spread fit specific categories (either T2‑T3 with no lymph node involvement, or T1‑T2 with a small amount of lymph node involvement).
  • The initial tumor sample must show tumor‑infiltrating lymphocytes (TILs) of 30% or more, indicating that at least 30% of the tissue is made up of immune cells fighting the tumor.
  • There must be enough tumor tissue available for laboratory testing.
  • Must have a performance status of 0 or 1 on the WHO scale, which means you are able to carry out daily activities with little or no limitation.
  • Must have no medical reason that would prevent receiving the study’s chemotherapy drugs or the medicine pembrolizumab.
  • Must have adequate bone marrow function, shown by blood tests that indicate:
    • Absolute neutrophil count (a type of white blood cell) at least 1,500 per microliter.
    • Hemoglobin (oxygen‑carrying protein) at least 10 g/dL.
    • Platelet count (helps blood clot) at least 100,000 per microliter.
    • Must have normal blood levels of potassium, magnesium, and calcium (above the lower limit of normal).
    • Must have adequate liver function, demonstrated by lab results that show:
      • Total bilirubin no more than 1.5 times the upper normal limit.
      • AST and ALT enzymes each no more than 2 times the upper normal limit.
      • Alkaline phosphatase no more than 2.5 times the upper normal limit.
      • Must have adequate kidney function, shown by either a creatinine level no more than 1.5 times the upper normal limit or an estimated glomerular filtration rate (eGFR) of at least 40 mL/min/1.73 m².
      • Must have a left ventricular ejection fraction (LVEF) of at least 50% on a heart ultrasound (echocardiogram), which measures how well the heart pumps blood.
      • Women who could become pregnant must have a negative pregnancy test at screening.
      • Women who could become pregnant must agree to use a highly effective method of contraception during the study and for at least 7 months after the last dose; it is also strongly recommended that their male partner uses a condom with spermicide during this time.
      • Must be covered by a social security system or be a beneficiary of such a system.
      • Must be able to understand and speak French without difficulty.
      • Must sign an informed consent form agreeing to take part in the study.

Who cannot join the trial?

26 criteria

  • Metastatic disease – cancer that has spread beyond the original breast to other parts of the body.
  • Ongoing acute urinary tract infection, existing bleeding in the bladder (hemorrhagic cystitis), or known blockage of the urinary tract.
  • Known or suspected hypersensitivity (severe allergy) to any ingredients in the study drugs, such as lactose.
  • Use of medicines that suppress the immune system (except normal hormone replacement) within the last 30 days.
  • Receiving a live weakened‑virus vaccine (for example, certain flu or yellow fever shots) within the last 30 days.
  • Active infections, including:
    • Tuberculosis (TB) – a bacterial lung infection.
    • Hepatitis B – a liver virus; positive surface antigen (HBsAg) means current infection.
    • Hepatitis C – a liver virus; must have a negative RNA test to be allowed.
    • HIV – a virus that attacks the immune system; must be treated with an undetectable viral load.
    • Significant heart problems, such as:
      • Heart failure classified as NYHA class II or higher (moderate limitation of activity).
      • Weak heart muscle (cardiomyopathy).
      • Recent heart attack (myocardial infarction), mini‑stroke (TIA), or stroke within the past 3 months.
      • Unstable irregular heartbeats (arrhythmias) or chest pain (unstable angina).
      • Participation in another clinical trial with experimental medicines within the past 3 weeks (or the time it takes for the drug to clear from the body).
      • Uncontrolled medical or mental health conditions, or significant substance dependence, that could interfere with completing the study.
      • Being a vulnerable individual as defined by French law, or unable to give informed consent.
      • Having breast cancer that has come back after previous treatment.
      • Having cancer in both breasts at the same time.
      • Current use of Millepertuis (St. John’s Wort), a herbal supplement.
      • Breast cancer that tests positive for estrogen receptor (ER) or progesterone receptor (PR) above 10%, or is HER2‑positive (a specific growth‑factor protein).
      • Any other cancer diagnosed within the past 3 years, except cancers that are considered fully treated and low‑risk.
      • Being pregnant, possibly pregnant without effective birth control, or breastfeeding.
      • Having a medical reason that makes an MRI scan unsafe (for example, certain metal implants).
      • Having an immunodeficiency – a condition that weakens the body’s ability to fight infections.
      • Having an active autoimmune disease that needs systemic (body‑wide) treatment within the past 3 years, such as inflammatory bowel disease, lupus, ankylosing spondylitis, scleroderma, multiple sclerosis, celiac disease, or Wegener’s granulomatosis.
      • Having received any prior chemotherapy or curative‑intent radiation therapy for the current breast cancer.
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Investigated drugs

  • Paclitaxel

    is a chemotherapy drug that stops cancer cells from dividing and growing. It is given through an IV infusion, where the medicine is mixed with a liquid and delivered directly into a vein.

  • Carboplatin

    is another chemotherapy medication that works by damaging the DNA of cancer cells, which stops them from multiplying. Like paclitaxel, it is administered by IV infusion.

  • Pembrolizumab

    is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. It is a type of checkpoint inhibitor and is also given through an IV infusion.

  • Cyclophosphamide

    is a chemotherapy agent that interferes with the DNA of cancer cells, preventing them from growing and dividing. It is delivered as a solution for injection into a vein.

  • Doxorubicin

    is a chemotherapy drug that inserts itself into cancer cell DNA and creates harmful free radicals, which kill the cells. It is administered by IV infusion.

  • Epirubicin

    is similar to doxorubicin; it attaches to cancer cell DNA and generates free radicals that destroy the cells. It is also given through an IV infusion.

What is already known about the treatment

  • Paclitaxel

    Given by IV infusion as a solution for dilution, paclitaxel is an approved chemotherapy drug widely used for breast and other cancers; it is well documented in medical literature. It works by locking the tiny tubes (microtubules) that cells need to divide, so cancer cells cannot multiply. This drug belongs to the taxane class of antineoplastic agents.

  • Carboplatin

    Administered by IV infusion as a solution for perfusion, carboplatin is a standard chemotherapy agent with extensive use in ovarian, lung and breast cancers and is well described in current medical sources. It damages the DNA inside cancer cells, preventing them from growing and dividing. Carboplatin is classified as a platinum‑based chemotherapy.

  • Pembrolizumab

    Delivered by IV infusion as a concentrate for solution, pembrolizumab is an approved immunotherapy found in many cancer studies and guidelines, including treatment of triple‑negative breast cancer. It blocks the PD‑1 protein on immune cells, allowing the body’s own defenses to recognize and attack tumors. This medication is a checkpoint inhibitor belonging to the immune‑modulating class.

  • Cyclophosphamide

    Given by IV infusion as a solution for injection, cyclophosphamide is a long‑standing chemotherapy drug listed in many treatment protocols and medical references. Inside the body it becomes active and breaks DNA strands, which kills rapidly dividing cancer cells. It is classified as an alkylating agent.

  • Doxorubicin

    Administered by IV infusion as a solution for perfusion, doxorubicin is a well‑known chemotherapy medicine used for breast cancer, leukemia and other tumors, with extensive literature support. It slides between DNA bases, stopping the genetic code from being copied, and also creates free radicals that damage cancer cells. Doxorubicin belongs to the anthracycline antibiotic class of antineoplastic drugs.

  • Epirubicin

    Delivered by IV infusion as a solution for perfusion, epirubicin is an approved chemotherapy agent similar to doxorubicin and is widely described in clinical practice for breast cancer. It inserts itself into DNA, blocking replication, and generates free radicals that further harm tumor cells. This drug is also an anthracycline antineoplastic agent.

Investigated diseases

Triple-negative breast cancer - Triple-negative breast cancer is a type of breast cancer that lacks estrogen receptors, progesterone receptors, and HER2 protein. Because it does not have these receptors, the tumor cells grow without hormonal or HER2‑driven signals. It often appears as a fast‑growing mass and is frequently diagnosed at a higher grade. The disease can spread from the breast to nearby lymph nodes and then to distant organs such as the lungs, liver, or bone. As the cancer advances, the size of the tumor and the number of affected lymph nodes typically increase.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-525040-18-00Protocol codeIPC 2025-068Estimated enrolment84 patientsSponsorInstitut Paoli Calmettes

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