Study of Paclitaxel, Carboplatin, and Durvalumab with or without Oleclumab for Patients with Untreated Advanced Triple-Negative Breast Cancer

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What is this study about?

This clinical trial is focused on studying a type of breast cancer known as triple-negative breast cancer (TNBC). This form of cancer is characterized by the absence of three common receptors known to fuel most breast cancer growths: estrogen, progesterone, and HER2. The study is specifically for patients who have not received prior treatment and whose cancer has either returned locally and cannot be surgically removed or has spread to other parts of the body.

The trial is testing a combination of medications to see how effective they are in treating this type of cancer. The medications being studied include Paclitaxel, Carboplatin, and Durvalumab (also known by its code name MEDI4736). Some patients will also receive an additional medication called Oleclumab (code name MEDI9447). These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to determine the safety and potential benefits of these medications when used together. The study is divided into two phases. In the first phase, the focus is on confirming the safety of the combination of these drugs. In the second phase, the study aims to evaluate the clinical benefits, such as how well the cancer responds to the treatment, by comparing patients who receive the combination with and without Oleclumab. Participants will receive regular infusions and be monitored over time to assess the effects of the treatment.

1 initial treatment phase

The study begins with the administration of medications through an intravenous infusion. This involves receiving the drugs directly into the bloodstream through a vein.

The medications used in this phase include paclitaxel, carboplatin, and durvalumab. These are given to treat triple-negative breast cancer that is locally recurrent, inoperable, or has spread to other parts of the body.

2 combination treatment with oleclumab

In addition to the initial medications, oleclumab may be added to the treatment regimen. This is to assess the safety and potential benefits of combining oleclumab with the other drugs.

The goal is to determine if the combination provides a clinical benefit, which is evaluated at 24 weeks from the first dose of the study drugs.

3 monitoring and assessment

Throughout the trial, the safety and effects of the treatment are closely monitored. This includes checking for any side effects and assessing the response of the cancer to the treatment.

Regular assessments are conducted to measure the size of the tumor and to check for any signs of disease progression.

4 end of treatment evaluation

At the end of the treatment period, a final evaluation is conducted to determine the overall response to the therapy.

This includes measuring the duration of response, progression-free survival, and overall survival rates.

Who Can Join the Study?

Must be at least 18 years old.
Must provide a sample of the original tumor from a previous biopsy or surgery.
At least 6 months must have passed since the last treatment aimed at curing the cancer and the first sign of the cancer coming back, unless the cancer is newly diagnosed and has spread.
Must have at least one tumor that can be measured to track changes.
Must have proper organ function, which includes:
- Enough white blood cells without needing extra help.
- Enough platelets, which help with blood clotting, without needing extra help.
- Enough hemoglobin, which carries oxygen in the blood, without needing extra help.
- Normal kidney function, measured by creatinine levels or a specific test called eGFR.
- Normal liver function, measured by bilirubin levels, unless a specific condition called Gilbert syndrome is present.
- Normal liver enzyme levels, unless the cancer has spread to the liver.
- Normal blood clotting ability, unless taking medication for blood clots.
Must be able to perform daily activities with little or no help, as measured by a specific scale called the ECOG Performance scale.
If able to have children, must agree to use effective birth control during the study and for 6 months after the last treatment. Must also have a negative pregnancy test before starting the study.
Must not have any conditions that would make it hard to follow the study plan.
Must not have any other illnesses that would make it unsafe to participate.
Must agree to provide tissue and blood samples for research.
Must give written consent to participate, following specific guidelines and regulations.
Must be female.
Must have a life expectancy of at least 12 weeks.
Must weigh more than 35 kg (about 77 pounds).
The cancer must be confirmed as a specific type called triple-negative breast cancer (TNBC), which has not been treated with systemic therapy and cannot be cured with current treatments. Newly diagnosed patients with cancer that has spread are eligible.
The cancer must not have receptors for estrogen or progesterone, which are hormones that can affect cancer growth.
The cancer must not have a protein called HER2, which can also affect cancer growth.
For phase II of the study, the tumor must be tested for specific proteins called PD-L1 and CD73.
Must provide samples from the cancer that has come back or spread, using specific types of biopsies. Certain types of samples are not acceptable.

Who Cannot Join the Study?

Patients who have already received treatment for their breast cancer.
Patients with breast cancer that can be removed by surgery.
Patients with breast cancer that is not classified as triple-negative. This means the cancer does not have certain receptors that some other breast cancers have.
Patients who are male, as the study is only for female patients.
Patients who are not considered part of the vulnerable population, which means those who might need extra protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Centr Georges Francois Leclerc	Dijon	France
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Institut Jules Bordet	Anderlecht	Belgium
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Grand Hopital De Charleroi	Charleroi	Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Centre Henri Becquerel	Rouen	France
Gasthuiszusters Antwerpen	Antwerp	Belgium
Clinique Saint-Pierre Ottignies (CSPO)	Ottignies	Belgium
Ipwwsjwk Bpjlyoxw	Bordeaux	France
Bmocxmtr Uqjzrqiogn Hbujgfor Crgvwh	Besançon	France
Iiqaxhib Pgpmwkzhinlmsla Cgqhse Ckzuwx	Marseille	France
Hhmgfzvj Ubdzogdstozami Sgdsashvln &gbfixw Hqxpzjt dy Hjvoriltuov	STRASBOURG, Alsace	France
Iupkcluc Ccxoz	Paris	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.07.2018
France	Not recruiting	01.07.2018

Trial locations

Investigated drugs:

Paclitaxel is a medication used in cancer treatment. It works by stopping cancer cells from dividing and growing, which can help to slow down or stop the spread of cancer.

Carboplatin is another cancer treatment drug. It damages the DNA of cancer cells, which can prevent them from multiplying and lead to their death.

Durvalumab is an immunotherapy drug. It helps the immune system recognize and attack cancer cells, which can help to control the growth of the cancer.

Oleclumab (MEDI9447) is an experimental drug being studied for its potential to enhance the effects of other cancer treatments. It targets a specific protein that may help cancer cells evade the immune system, and by blocking this protein, oleclumab may help the immune system better fight the cancer.

Investigated diseases:

Triple-Negative Breast Cancer (TNBC) – 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. Because it does not have these receptors, TNBC does not respond to hormonal therapy or therapies that target HER-2 receptors. It is often more aggressive and has a higher likelihood of spreading and recurring compared to other breast cancer types. TNBC is typically diagnosed through a biopsy and is characterized by its rapid growth and tendency to spread to other parts of the body. It is more common in younger women and those with a BRCA1 gene mutation. The progression of TNBC can vary, but it often requires a combination of treatments due to its aggressive nature.

Trial ID:

2024-511850-34-00

Protocol code:

IJB-SYNERGY-012017

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Paclitaxel, Carboplatin, and Durvalumab with or without Oleclumab for Patients with Untreated Advanced Triple-Negative Breast Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?