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

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What is this study about?

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.

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 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 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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Hopital Tenon	Paris	France
Institut Sainte Catherine	Avignon	France
Iwrxdkda Pcjidzapbhmaxoz Chfpqv Chpjbx	Marseille	France
Avmiibmdwz Pfugkvhq Hwnahquq Dh Mprleeigb	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	15.06.2026

Trial locations

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.

Investigated Diseases:

Triple negative breast cancer

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 ID:

2025-525040-18-00

Protocol code:

IPC 2025-068

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?