Study on the Safety and Effectiveness of Durvalumab, Paclitaxel, and Drug Combinations for Patients with Metastatic Triple Negative Breast Cancer

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What is this study about?

This clinical trial is focused on studying treatments for metastatic triple-negative breast cancer (TNBC), a type of breast cancer that does not have the usual hormone receptors or the HER2 protein. The study involves several medications, including Durvalumab (also known as MEDI4736), Paclitaxel, Datopotamab deruxtecan, Oleclumab (MEDI9447), Capivasertib, and DS-8201a (Trastuzumab deruxtecan). These treatments are being tested to see how safe and effective they are when used alone or in combination.

The purpose of the study is to evaluate the safety and effectiveness of these treatments for patients with TNBC. The study is divided into two parts. In the first part, the focus is on understanding the safety and how well patients tolerate the combination of Durvalumab with other new cancer treatments, with or without Paclitaxel. The second part aims to assess how effective these combinations are in treating the cancer. Participants will receive the treatments through intravenous infusions or oral tablets, depending on the specific medication being tested.

Throughout the study, participants will be monitored for any side effects and changes in their health. The study will also track how the cancer responds to the treatments, looking for signs of improvement or progression. This research aims to find better treatment options for those with metastatic triple-negative breast cancer, offering hope for improved outcomes in the future.

1 enrollment

Upon joining the study, eligibility is confirmed based on specific criteria such as age, gender, and medical condition.

The condition being studied is Stage IV Triple Negative Breast Cancer, a type of breast cancer lacking certain receptors.

2 initial assessment

An initial assessment is conducted to establish baseline health status. This includes physical examinations and laboratory tests.

3 treatment phase 1

The first part of the treatment involves receiving durvalumab and possibly other therapies such as paclitaxel.

Durvalumab is administered as a solution for infusion, meaning it is given through a vein.

4 treatment phase 2

In the second phase, the focus is on assessing the effectiveness of the treatment combinations.

The treatment may include additional novel oncology therapies, which are new cancer treatments being tested.

5 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to track health status and any side effects.

This includes checking vital signs, conducting laboratory tests, and performing physical examinations.

6 completion and evaluation

At the end of the trial, a final evaluation is performed to assess the overall response to the treatment.

The main outcomes measured include the objective response rate, which is the percentage of patients with a significant reduction in cancer size.

Who Can Join the Study?

Must be female.
Must be at least 18 years old at the time of screening.
Must have a diagnosis of advanced or metastatic Triple Negative Breast Cancer (TNBC), which means the cancer has spread and cannot be removed by surgery.
Must not have received any prior treatment for Stage IV TNBC, which is the most advanced stage of breast cancer.
Must have at least one measurable lesion, which is an area of cancer that can be accurately measured and has not been treated with radiation.
Must have a WHO/ECOG status of 0 or 1 at enrollment, which indicates the level of daily activity and ability to care for oneself. A status of 0 means fully active, and 1 means restricted in physically strenuous activity but able to carry out light work.
For patients in Arm 6 (durvalumab and DS-8201a): Must provide documentation showing advanced or metastatic TNBC with HER2 low tumor expression. This means the cancer cells have low levels of a protein called HER2.
For patients in Arm 8 (durvalumab + Dato-DXd): Must have a PD-L1 positive tumor, which means the tumor has a protein that may help the cancer hide from the immune system.

Who Cannot Join the Study?

Patients who have a different type of breast cancer that is not Triple Negative Breast Cancer (TNBC). TNBC is a type of breast cancer that does not have certain proteins like estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2.
Patients who are male, as the study is only for female participants.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli	Lublin	Poland
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej	Opole	Poland
Mruk-Med I Sp. z o.o.	Rzeszow	Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Nhzxtmid Idsmlvlo Oiowkaxyd Ibq Mwkqi Ssuioufeavwrklnupfqdqcgiplfm Ixhwkbwr Byrwlztf	Cracow	Poland
Uzvznjqsmgsukk Cgsggmb Kpttcbdqj	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	09.07.2024

Trial locations

Investigated drugs:

Durvalumab is a medication used in this trial to help the immune system detect and fight cancer cells. It is a type of immunotherapy that targets a specific protein on the surface of cancer cells, helping the body’s immune system to attack and destroy them.

Paclitaxel is a chemotherapy drug used in this trial to stop the growth of cancer cells. It works by interfering with the normal function of microtubules during cell division, which prevents cancer cells from multiplying and spreading.

Novel Oncology Therapies are new treatments being tested in this trial alongside durvalumab and paclitaxel. These therapies are designed to target specific pathways or mechanisms in cancer cells, potentially improving the effectiveness of treatment and offering new options for patients with metastatic triple-negative breast cancer.

Investigated diseases:

Triple negative breast cancer

Triple Negative Breast Cancer – This is a subtype of breast cancer that does not express the estrogen receptor, progesterone receptor, or human epidermal growth factor receptor 2. It is known for its aggressive nature and rapid growth. Unlike other breast cancer types, it does not respond to hormonal therapy or therapies that target HER2 receptors. The disease often presents at a higher stage and can spread more quickly to other parts of the body. It is more common in younger women and those with a BRCA1 gene mutation. The progression of this cancer can vary, but it typically requires a combination of treatments to manage.

Trial ID:

2024-511646-40-00

Protocol code:

D933LC00001

NCT ID:

NCT03742102

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of Durvalumab, Paclitaxel, and Drug Combinations for Patients with Metastatic Triple Negative Breast Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?