Study on Nivolumab with Paclitaxel and Carboplatin for Early Stage Triple Negative Breast Cancer Patients

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What is this study about?

This clinical trial is focused on studying early stage triple negative breast cancer, a type of breast cancer that does not have three common receptors known to fuel most breast cancer growths. The study is testing a treatment that combines a medication called nivolumab with chemotherapy drugs paclitaxel and carboplatin. Nivolumab, also known by its code name BMS936558, is a type of drug that helps the immune system fight cancer cells. The chemotherapy drugs, paclitaxel and carboplatin, are used to kill cancer cells directly.

The purpose of the study is to evaluate how effective this combination treatment is when given before surgery to patients with early stage triple negative breast cancer. Participants in the study will receive either nivolumab alone first, followed by the chemotherapy drugs, or they will receive nivolumab together with the chemotherapy drugs from the start. This approach is known as neoadjuvant therapy, which means treatment given as a first step to shrink a tumor before the main treatment, which is usually surgery.

The study will follow participants through their treatment course, which includes receiving the medications through an intravenous infusion, meaning the drugs are given directly into a vein. The study will monitor the response of the cancer to the treatment, as well as the safety and tolerability of the drugs. The goal is to see if the cancer can be reduced or eliminated before surgery, improving the chances of a successful operation and potentially better long-term outcomes for patients.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and cancer stage.

The study is designed for individuals with early-stage triple negative breast cancer.

2 randomization

Participants are randomly assigned to one of two groups: one receiving nivolumab alone initially, and the other receiving nivolumab with chemotherapy from the start.

This process helps to compare the effectiveness of the two treatment approaches.

3 treatment phase

The treatment involves nivolumab, administered as an intravenous infusion. The specific dosage and frequency are determined by the study protocol.

In one group, nivolumab is given alone initially, while in the other group, it is given alongside chemotherapy drugs paclitaxel and carboplatin.

4 monitoring and assessments

Throughout the treatment, regular monitoring and assessments are conducted to evaluate the response to the therapy.

These assessments include imaging tests and laboratory evaluations to track the cancer’s response and any side effects.

5 surgery

Surgery is scheduled within four weeks after the final dose of the neoadjuvant therapy.

The goal is to remove any remaining cancerous tissue.

6 post-surgery evaluation

After surgery, further evaluations are conducted to determine the pathological complete response, which indicates the absence of cancer in the breast and lymph nodes.

Additional assessments may include measuring changes in specific markers and overall survival rates.

7 follow-up

Participants are followed up for a period of three years to monitor long-term outcomes such as event-free survival and overall survival.

Regular check-ups and tests are part of this follow-up phase to ensure ongoing health and to detect any recurrence of cancer.

Who Can Join the Study?

Must be a female or male who is 18 years old or older.
Must have an ECOG performance status of 0-1, which means the person is fully active or has some symptoms but can still do light work.
Must have early-stage triple negative breast cancer that has not spread to other parts of the body (non-metastatic) and has not been treated before. The cancer should be at Stage I or II, as determined by a doctor using a mammogram or ultrasound of the breasts, and an ultrasound or physical exam of the armpit area.
If the cancer has spread to the lymph nodes, a CT scan or PET CT of the chest and abdomen (and a bone scan if needed) should be done to make sure the cancer hasn’t spread to other parts of the body.
The cancer must be non-metastatic, possibly removable by surgery, and only in one breast. It should be confirmed by a test called histology to be triple negative, which means:
- ER negative: Less than 1% of the cancer cells test positive for estrogen receptors.
- PR negative: Less than 10% of the cancer cells test positive for progesterone receptors.
- HER2 negative: The cancer tests 0 or 1+ on a test called IHC, or is negative on tests called ISH, FISH, or SISH.
Must be able to start the study treatment within 14 days after being randomly assigned to a treatment group.
Surgery must be possible within 4 weeks after the last dose of the study’s intravenous (IV) therapy. Radiation before surgery is not allowed for anyone whose cancer can be removed by surgery after the study treatment.
Must have adequate organ function, which means the organs are working well. All necessary lab tests should be done within 14 days after being randomly assigned to a treatment group.

Who Cannot Join the Study?

Patients with medical conditions other than early stage triple negative breast cancer cannot participate. This type of breast cancer does not have certain receptors that are common in other breast cancers.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to follow the study procedures or who have other health issues that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate, as the study may involve treatments that could affect the baby.
Patients who have participated in another clinical trial recently may not be eligible to participate in this study.
Patients with a history of certain other medical conditions or treatments that could interfere with the study results may not be eligible.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.04.2024

Trial locations

Investigated drugs:

Nivolumab

Nivolumab is an immunotherapy medication used in this trial to help the body’s immune system recognize and attack cancer cells. It is being tested as a treatment for early-stage triple-negative breast cancer, either given alone at the start or together with chemotherapy.

Paclitaxel is a chemotherapy drug that works by stopping cancer cells from dividing and growing. In this trial, it is used in combination with other treatments to help shrink tumors before surgery in patients with early-stage triple-negative breast cancer.

Carboplatin is another chemotherapy medication used in this study. It damages the DNA of cancer cells, which prevents them from multiplying. It is given alongside other treatments to enhance the effectiveness of the therapy for early-stage triple-negative breast cancer.

Investigated diseases:

Triple negative breast cancer

Early Stage Triple Negative Breast Cancer – This is a type of breast cancer that lacks three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. It is called “triple negative” because the cancer cells test negative for these three receptors. This type of cancer tends to grow and spread more quickly than other types of breast cancer. It is more common in women under 40, African American women, and those with a BRCA1 mutation. The disease is often diagnosed at an early stage, which means it has not spread beyond the breast or nearby lymph nodes. Treatment typically involves a combination of surgery, chemotherapy, and sometimes radiation therapy.

Trial ID:

2024-512625-86-00

Protocol code:

BCT 1902

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Nivolumab with Paclitaxel and Carboplatin for Early Stage Triple Negative Breast Cancer Patients

What is this study about?

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