Study on Restoring Immunotherapy Sensitivity in Advanced Triple Negative Breast Cancer Using Ceralasertib, Durvalumab, and Paclitaxel Albumin-Bound

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What is this study about?

This clinical trial is focused on studying a type of breast cancer known as advanced triple-negative breast cancer (TNBC). This form of cancer does not have the three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER2 protein. The study aims to explore the effectiveness of a treatment plan that includes a medication called ceralasertib, followed by a combination of two other medications, durvalumab and paclitaxel albumin-bound. Ceralasertib is taken in tablet form, while durvalumab and paclitaxel albumin-bound are given through an infusion, which means they are administered directly into the bloodstream.

The purpose of this study is to evaluate how well this treatment plan works for patients whose cancer has returned after previous treatments. The study will involve a period where participants will first receive ceralasertib to prepare their bodies, followed by the combination of durvalumab and paclitaxel albumin-bound. This approach is being tested to see if it can help restore the body’s sensitivity to immunotherapy, a type of treatment that uses the body’s immune system to fight cancer.

Participants in the study will be monitored over a period of time to assess the progression of their cancer and any responses to the treatment. The study will also track the overall health and survival of participants, as well as any side effects they may experience. The goal is to determine if this treatment plan can effectively control the cancer and improve the quality of life for those affected by advanced triple-negative breast cancer.

1 initial assessment

Upon joining the trial, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of advanced triple negative breast cancer and ensuring that previous treatments included immunotherapy and chemotherapy.

Organ functions are evaluated, and a negative pregnancy test is required. The ability to comply with the study protocol, including swallowing and retaining oral medication, is assessed.

2 ceralasertib administration

The first phase involves taking ceralasertib orally. This medication is provided in tablet form. The specific dosage and frequency are determined by the study protocol and are tailored to individual needs.

3 combination therapy

Following the ceralasertib phase, a combination therapy is initiated. This includes durvalumab and paclitaxel albumin-bound, both administered through infusion.

The duration and frequency of these infusions are specified in the study protocol and are based on individual response and tolerance.

4 monitoring and evaluation

Throughout the trial, regular monitoring is conducted to assess the response to treatment. This includes imaging studies and other evaluations to track disease progression or stability.

The primary goal is to measure progression-free survival, which is the time from the start of treatment until disease progression or death.

5 completion and follow-up

Upon completion of the treatment phases, follow-up assessments are conducted to evaluate overall response and any potential adverse effects.

The trial aims to determine the overall survival rate and the duration of response to the treatment.

Who Can Join the Study?

Patients must have advanced triple negative breast cancer. This means the cancer has spread and does not have certain receptors that are common in other breast cancers.
The cancer must have come back after treatment aimed at curing it, which included immune checkpoint inhibitors (ICIs) and chemotherapy. ICIs are drugs that help the immune system fight cancer.
Patients should not have received chemotherapy for the cancer that has spread.
Patients must have acceptable organ functions, which will be checked within 28 days before starting the trial.
If female, a negative pregnancy test is required, and patients must agree to use effective birth control from the start of the trial until 90 days after the last dose of the drug durvalumab.
There must be proof that the disease has gotten worse since the last treatment, which can be shown through a biopsy, pathology, or imaging report.
Patients need to sign the ATRiBRAVE trial written informed consent, which is a document explaining the study and confirming their agreement to participate.
Patients must be 18 years or older.
Patients should be able to follow the study rules, including being able to swallow and keep down oral medication.
A sample of the original tumor tissue must be available, either as a formalin-fixed, paraffin-embedded block (FFPE) or at least 10-20 unstained tumor slides.
The most recent tumor sample must show negative ER/PgR and HER2 status. This means the cancer does not have certain proteins that are often found in other types of breast cancer.
The disease must be evaluable, meaning it can be measured and tracked, as defined by a standard called RECIST 1.1.
Patients must have an ECOG performance status of 0-1, which indicates they are fully active or have some symptoms but can still carry out light work.

Who Cannot Join the Study?

Patients who have not experienced a return of their breast cancer after initial treatment.
Patients who have not received immune checkpoint inhibitors (ICIs) and chemotherapy as part of their initial treatment.
Patients with medical conditions other than advanced triple negative breast cancer.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Akbonqn Utk Ibvnd Dm Rlwoja Eyfggp	Reggio Emilia	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	30.09.2022

Trial locations

Investigated drugs:

Ceralasertib is a medication being studied for its ability to restore sensitivity to immunotherapy in patients with advanced triple-negative breast cancer. It is used in this trial to prime the cancer cells, potentially making them more responsive to subsequent treatments.

Durvalumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells. In this trial, it is used in combination with other treatments to enhance the body’s immune response against the cancer.

Nab-paclitaxel is a chemotherapy drug that works by stopping the growth of cancer cells. It is used in this trial alongside other therapies to help control the spread of cancer in patients with advanced triple-negative breast cancer.

Advanced 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 HER2 protein. It is considered more aggressive than other types of breast cancer because it grows quickly, is more likely to have spread at the time it is found, and is more likely to come back after treatment. The disease progresses as cancer cells multiply and spread to other parts of the body, often leading to the formation of tumors in other organs. It is characterized by its rapid growth and the absence of targeted hormonal therapies, making it challenging to treat. The progression of the disease can vary, but it often involves the cancer spreading to lymph nodes and other organs.

Trial ID:

2024-513721-23-00

Protocol code:

IFOM-CPT008/2022/PO0

NCT ID:

NCT05582538

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Restoring Immunotherapy Sensitivity in Advanced Triple Negative Breast Cancer Using Ceralasertib, Durvalumab, and Paclitaxel Albumin-Bound

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?