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Study of Patritumab Deruxtecan with or without Endocrine Therapy for High-Risk HR+/HER2- Early Breast Cancer in Untreated Patients

Verified siteInvestigationalNo 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 HR-positive/HER2-negative high-risk early breast cancer. The study is investigating a treatment called Patritumab deruxtecan (U3-1402), which is a medication given through an injection. This medication is being tested either alone or in combination with another treatment called endocrine therapy, which involves using hormones to treat cancer. The purpose of the study is to evaluate how effective this treatment is when given to patients who have not yet received any other treatment for their breast cancer.

Participants in the study will receive the treatment as a neoadjuvant therapy, which means it is given before the main treatment, such as surgery, to help shrink the tumor. The study will involve regular monitoring and assessments to see how the cancer responds to the treatment. This includes using imaging techniques like MRI to check the size of the tumor and other tests to evaluate the cancer's characteristics. The study will also look at the overall response of the tumor to the treatment and any changes in the cancer's behavior over time.

The trial aims to gather information on the effectiveness of Patritumab deruxtecan in reducing the size of the tumor and improving the chances of successful surgery. It will also assess the safety of the treatment and any side effects that may occur. The study is expected to continue for several years to collect comprehensive data on the long-term outcomes for patients receiving this treatment. Participants will be closely monitored throughout the study to ensure their safety and to gather valuable information that could help improve treatment options for breast cancer in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will be required to sign an informed consent form, confirming your understanding and agreement to participate in the study.
A series of initial tests will be conducted to ensure you meet the eligibility criteria, including a blood test to confirm adequate blood and organ function, and a pregnancy test if applicable.
Step 2
Treatment phase
You will receive the study medication, patritumab deruxtecan, administered intravenously. The dosage is 5.6 mg per kilogram of body weight.
The medication will be given either alone or in combination with letrozole, depending on your specific treatment plan.
The treatment is scheduled as a neoadjuvant therapy, which means it is given before the main treatment, such as surgery.
Step 3
Monitoring and follow-up
Throughout the trial, regular monitoring will be conducted to assess your response to the treatment. This includes imaging tests like MRI to evaluate the tumor's response.
You will also be monitored for any side effects or adverse reactions to the medication. It is important to report any new symptoms or changes in your health to the study team.
Step 4
Surgery and evaluation
After completing the treatment phase, you will undergo surgery to remove the tumor. The surgical procedure will be followed by a detailed examination of the tissue to assess the effectiveness of the treatment.
The primary goal is to achieve a complete absence of invasive cancer in the breast and lymph nodes, which will be evaluated by a pathologist.
Step 5
Long-term follow-up
Following surgery, you will continue to be monitored for several years to track your health and any long-term effects of the treatment.
Regular follow-up visits will be scheduled to assess your overall health and to detect any signs of cancer recurrence.

Who can join the trial?

19 criteria

Must have signed an informed consent form (ICF).
Must have good blood and organ function.
Must be willing and able to follow the trial procedures.
Women of childbearing potential must have a negative pregnancy test.
Female participants must not donate or use their eggs during the study and for at least 7 months after the last dose of the study drug.
Women of childbearing potential must agree to use highly effective birth control methods.
Men who are sexually active with women of childbearing potential must agree to use birth control and follow guidelines to protect against pregnancy during the study and for a specified time after the last dose.
Male participants must not freeze or donate sperm during the study and for at least 4 months after the last dose of the study drug.
Participants can be either postmenopausal or pre-menopausal.
Must be able to swallow pills.
Must have a left ventricular ejection fraction (LVEF) of at least 50%. This is a measure of how well the heart pumps blood.
Must be at least 18 years old.
Must have a confirmed diagnosis of non-metastatic primary invasive breast cancer that is untreated and recently diagnosed, specifically Stage II to Stage IIIB, with no spread to distant parts of the body. Must have at least one tumor that is 10 mm or larger as seen on an MRI.
The tumor must be ER-positive and/or PgR-positive and HER2-negative. These are specific characteristics of the cancer cells.
Must have a Ki67 level of at least 20% or a high genomic risk as defined by specific tests like Oncotype DX, Mammaprint, Endopredict, or Prosigna.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, which indicates the level of daily functioning.
The breast cancer must be suitable for primary surgery.
Must provide a sample of the tumor tissue from before treatment for analysis.
Must be eligible for chemotherapy before surgery (neoadjuvant chemotherapy).

Who cannot join the trial?

5 criteria

Patients who have already received treatment for their breast cancer cannot participate. This means the study is only for those who are treatment naïve, or have not yet been treated.
Patients with breast cancer that is not HR+/HER2-negative are excluded. This refers to a specific type of breast cancer that tests positive for hormone receptors (HR+) and negative for a protein called HER2.
Patients whose breast cancer is not considered high-risk are not eligible. High-risk means there is a greater chance of the cancer returning or spreading.
Patients with breast cancer that is not operable cannot join. Operable means the cancer can be removed through surgery.
Patients who are not suitable for neoadjuvant treatment are excluded. Neoadjuvant treatment is therapy given before the main treatment, like surgery, to shrink the tumor.

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Verified sites

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

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Responsive
Barcelona, Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Verified
Lleida, Spain
Hospital Universitari General De Catalunya
Verified
Sant Cugat Del Valles, Spain

Trial locations

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Investigated drugs

Patritumab Deruxtecan
is a type of targeted cancer treatment. It works by attaching to a specific protein called HER3 on the surface of cancer cells. Once attached, it delivers a powerful anti-cancer drug directly into the cancer cell, which can help to stop the cancer from growing and spreading. This medication is being tested to see how well it works for people with a certain type of breast cancer.
Letrozole
is a medication that helps to lower the levels of estrogen in the body. Estrogen can help some breast cancers to grow, so by reducing its levels, letrozole can help to slow down or stop the growth of these cancers. It is often used in combination with other treatments to improve their effectiveness.

Patritumab Deruxtecan

What is already known about the treatment

Patritumab deruxtecan (HER3-DXd; U3-1402) – This medication is administered intravenously, meaning it is given through a vein. It is currently being studied in clinical trials for its effectiveness in treating patients with a specific type of breast cancer known as HR+/HER2-negative high-risk early breast cancer. The main therapeutic use of this medication is as a neoadjuvant treatment, which means it is given before the main treatment to help shrink the tumor. At the molecular level, patritumab deruxtecan works by targeting and binding to a protein called HER3 on cancer cells, delivering a toxic drug directly to the cancer cells to kill them. It is classified as an antibody-drug conjugate, which is a type of targeted cancer therapy.

Investigated diseases

Hormone Receptor-Positive/HER2-Negative High-Risk Early Breast Cancer – This type of breast cancer is characterized by the presence of hormone receptors and the absence of excess HER2 protein. It typically begins in the breast tissue and can spread to nearby lymph nodes. The cancer cells grow in response to hormones like estrogen or progesterone. As the disease progresses, it may invade surrounding tissues and potentially spread to other parts of the body. The risk is considered high due to factors like tumor size, grade, and lymph node involvement. Early detection and monitoring are crucial for managing the disease's progression.