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Study on the Effects of Durvalumab, Oleclumab, and Chemotherapy in Patients with Luminal B Breast Cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of breast cancer known as luminal B breast cancer. The study is exploring the effects of combining different treatments to see if they can improve the response of the cancer to therapy. The treatments being tested include a combination of chemotherapy drugs and a type of precise radiation therapy called Stereotactic Body Radiotherapy (SBRT). The chemotherapy drugs involved in the study are oleclumab (also known by its code name MEDI9447), durvalumab (also known by its code name MEDI4736), cyclophosphamide, doxorubicin hydrochloride, and paclitaxel. Some participants may receive a placebo instead of certain drugs to compare the effects.

The purpose of the study is to see if adding these treatments can improve the response of the primary tumor and any cancer that has spread to nearby lymph nodes. Participants will be randomly assigned to different groups, each receiving a different combination of treatments. The study will monitor the response of the cancer to these treatments over time, with regular assessments to track progress. The study aims to find out if these combinations can lead to better outcomes for patients with luminal B breast cancer.

Throughout the study, participants will undergo various tests and procedures to monitor their health and the effects of the treatments. These may include imaging tests like MRI to measure the size of the tumor and check for any changes. The study will also collect tissue and blood samples to help understand how the treatments are working. The trial is expected to continue for several years, with follow-up assessments to evaluate long-term outcomes such as survival and recurrence of the cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
Upon joining the study, the patient will begin the initial treatment phase. This involves receiving a combination of medications designed to treat luminal B breast cancer.
The medications include oleclumab and durvalumab, both administered as a concentrate for solution for infusion. Additionally, cyclophosphamide, doxorubicin hydrochloride, and paclitaxel are given intravenously.
The specific dosage, frequency, and duration of each medication will be determined by the study protocol and the patient's individual treatment plan.
Step 2
Stereotactic body radiotherapy
During this phase, the patient will receive stereotactic body radiotherapy (SBRT) to the primary tumor. This is a precise form of radiation therapy aimed at targeting the cancer cells while minimizing damage to surrounding healthy tissue.
The timing and number of sessions will be specified by the study protocol.
Step 3
Surgery
Following the completion of the initial treatment and radiotherapy, the patient will undergo surgery to remove any remaining cancerous tissue.
The type of surgery will depend on the response to the previous treatments and the specific characteristics of the tumor.
Step 4
Follow-up phase
After surgery, the patient will enter a follow-up phase. This involves regular monitoring to assess the effectiveness of the treatment and to check for any signs of cancer recurrence.
Follow-up assessments will occur at specified intervals, such as 3 years and 5 years after surgery, to evaluate long-term outcomes like event-free survival and overall survival.

Who can join the trial?

26 criteria

Must be 18 years old or older.
Must be female.
Must have a negative pregnancy test if able to have children, done within 2 weeks before starting the study.
Women who can have children must agree to use a highly effective method of birth control during the study and for 12 months after the last treatment. It is strongly recommended that their male partners also use a condom with spermicide during this time.
Must have adequate bone marrow function, which means:
- Enough white blood cells (absolute neutrophil count ≥ 1500/µL).
- Enough red blood cells (hemoglobin ≥ 9.0 g/dL).
- Enough platelets (≥ 100,000/µL).
- Must have adequate liver function, which means:
  - Serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN). If you have Gilbert’s syndrome, ≤ 3 times ULN is allowed.
  - AST (SGOT) and ALT (SGPT) ≤ 3.0 times ULN.
  - Must have adequate kidney function, which means:
    
    Creatinine ≤ 1.5 times ULN or estimated glomerular filtration rate (eGFR) ≥ 40 ml/min/1.73m².
    Must have adequate blood clotting function, which means:
    
    International Normalized Ratio (INR) ≤ 1.5 times ULN.
    Must complete all necessary screening procedures within 28 days before randomization.
    Must be willing to provide tissue and blood samples for research purposes.
    Must have a left ventricular ejection fraction (LVEF) ≥ 50%, which is a measure of heart function. This test is accepted if done within 6 months before the start of screening.
    Must sign an Informed Consent form before any study-related procedures.
    Must have a tumor sample provided for specific testing during the screening period.
    Must have an ECOG performance status ≤ 1, which is a measure of daily living abilities.
    Must weigh 35 kg or more.
    Must have a diagnosis of invasive breast adenocarcinoma that is estrogen receptor-positive (ER-positive) and HER2-negative, with specific tumor characteristics.
    Must agree to have new biopsies done for study purposes.
    Must have a MammaPrint genomic high-risk score according to centralized testing, with specific conditions for testing.
    Must have a tumor size determined by MRI imaging:
    
    If no lymph node involvement (cN0): tumor size ≥ 2 cm.
    If lymph node involvement (cN1, cN2, or cN3): tumor size ≥ 1.5 cm.
    Multifocal, multicentric, unilateral, or bilateral breast adenocarcinoma tumors are allowed if all conditions are met, including:
    
    All tumor areas are ER+/HER2-.
    All areas can receive specific treatment.
    Specific conditions for biopsy and treatment are met.

Who cannot join the trial?

3 criteria

Patients who do not have Luminal B Breast Cancer cannot participate.
Only female patients can participate; male patients are excluded.
Patients who are part of a vulnerable population are not eligible. This means people who might be at a higher risk of harm or exploitation.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centr Georges Francois Leclerc
Verified
Dijon, France
Cliniques Universitaires Saint-Luc
Responsive
Woluwe-Saint-Lambert, Belgium
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium

Trial locations

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Investigated drugs

Durvalumab
is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, it is being tested to see if it can improve the response of breast cancer tumors when used alongside other treatments.
Oleclumab
is another immunotherapy drug. It is designed to block certain signals that cancer cells use to protect themselves from the immune system. By blocking these signals, oleclumab may help your immune system better target and destroy cancer cells. This trial is exploring whether adding oleclumab to the treatment plan can enhance the effectiveness of the therapy for breast cancer.

What is already known about the treatment

Durvalumab
Durvalumab is administered as an intravenous infusion, meaning it is given directly into a vein through a needle. It is currently being studied in clinical trials for its effectiveness in treating luminal B breast cancer, a specific type of breast cancer. The main therapeutic use of durvalumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein called PD-L1, which can prevent the immune system from attacking cancer cells. Durvalumab is classified as an immunotherapy drug, specifically a checkpoint inhibitor.
Oleclumab
Oleclumab is also administered as an intravenous infusion. It is being investigated in clinical trials for its potential to treat luminal B breast cancer. The primary therapeutic goal of oleclumab is to enhance the body's immune response against cancer. It works by targeting a protein called CD73, which is involved in the production of a molecule that can suppress the immune system. By inhibiting CD73, oleclumab aims to boost the immune system's ability to fight cancer. Oleclumab is classified as an immunotherapy agent.

Investigated diseases

Luminal B Breast Cancer – Luminal B Breast Cancer is a subtype of breast cancer characterized by the presence of hormone receptors and a higher proliferation rate compared to Luminal A. It often has a higher expression of the protein Ki-67, which indicates rapid cell growth. This type of cancer can be more aggressive and may grow and spread faster than other types of breast cancer. It typically involves the formation of a tumor in the breast tissue, which can invade surrounding tissues and potentially spread to lymph nodes. Over time, the cancer cells can metastasize to other parts of the body, such as bones, liver, or lungs. The progression of the disease can vary, with some cases remaining localized while others may advance to more widespread involvement.