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Study on the Safety and Effects of Lutetium Lu-177 and ABY-271 in Patients with HER2-Positive Metastatic Breast Cancer

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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 HER2-positive metastatic breast cancer. This is a form of cancer where the disease has spread to other parts of the body and has a high level of a protein called HER2, which promotes the growth of cancer cells. The trial is testing a new treatment called [177Lu]Lu-ABY-271, which is a solution given through an intravenous infusion. This treatment combines a radioactive substance, Lutetium Lu-177, with a protein called ABY-271 to target and treat cancer cells.

The purpose of the study is to evaluate the safety and tolerability of this new treatment. Participants will receive a single dose of the treatment, and researchers will monitor how the treatment is distributed in the body, particularly in tumors and important organs. The study is divided into two parts, and participants will be randomly assigned to one of these parts. Throughout the study, participants will undergo various tests and assessments to ensure their safety and to gather information on how the treatment affects their body.

Participants will be closely monitored for any side effects or changes in their health, including vital signs and heart function. The study will also measure how much of the treatment is absorbed by different organs and tumors. This information will help researchers understand the potential benefits and risks of [177Lu]Lu-ABY-271 for treating HER2-positive metastatic breast cancer. The trial aims to provide valuable insights into the treatment's effectiveness and safety, contributing to the development of new therapies for this type of cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be required to provide a signed declaration of informed consent and a data protection declaration. This ensures that you understand the trial and agree to participate.

    You must meet certain criteria, such as being at least 18 years old, having a life expectancy of at least 3 months, and having HER2-positive metastatic breast cancer that cannot be surgically removed.

  2. Step 2

    Screening visit

    During the screening visit, your eligibility will be confirmed. This includes checking your medical history and performing necessary tests.

    For females of childbearing potential, a negative serum human chorionic gonadotropin (hCG) test is required to confirm you are not pregnant.

  3. Step 3

    Preparation for treatment

    You will be informed about the need to use adequate contraceptive methods from the screening visit until 12 weeks after receiving the treatment, if applicable.

    You will be assessed for your willingness and capability to comply with all trial procedures.

  4. Step 4

    Treatment administration

    You will receive a single intravenous (IV) infusion of the study medication, [177Lu]Lu-ABY-271. This is a solution administered directly into your bloodstream through a vein.

    The main objective of this stage is to evaluate the safety and tolerability of the medication.

  5. Step 5

    Monitoring and follow-up

    After the infusion, you will be monitored for any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs).

    Regular assessments will be conducted to check changes in safety laboratory parameters, vital signs, and heart function using an echocardiogram (ECHO) and a 12-lead electrocardiogram (ECG).

  6. Step 6

    Evaluation of treatment effects

    The trial will measure the absorbed dose of the medication in your organs and tumors, as well as the concentration of the medication in your blood.

    The trial will also assess the tumor response to the treatment using specific criteria.

Who can join the trial?

14 criteria

  • The study is for females only.
  • You must be at least 18 years old.
  • You must have HER2-positive metastatic breast cancer, which means your cancer has spread to other parts of your body and has a specific protein called HER2.
  • You must have a life expectancy of at least 3 months as estimated by the doctor.
  • You must have unresectable locally advanced or metastatic breast cancer, meaning the cancer cannot be removed by surgery and has spread.
  • You must have a tumor lesion (an area of cancer) that is at least 15 mm in size.
  • Your Eastern Cooperative Oncology Group (ECOG) performance status must be 2 or less, which is a scale used to assess how your disease affects your daily living abilities.
  • If you are of childbearing potential, you must have a negative pregnancy test at the screening visit.
  • If you are of childbearing potential, you must be willing and able to use adequate contraceptive methods from the screening visit until 12 weeks after receiving the study drug. This means using highly effective birth control methods.
  • You must be willing and able to follow all the trial procedures as judged by the doctor.
  • For Part A: You must be in treatment or planning to start a new line of standard anti-tumor therapy.
  • For Part B: You must have progressive disease, meaning the cancer is growing, as shown by recent medical imaging.
  • For Part B: You must have received at least 3 lines of standard anti-tumor therapy in a palliative setting, which is treatment aimed at relieving symptoms and improving quality of life.
  • For Part B: You must have received the last dose of your previous line of therapy and have no ongoing treatment-related side effects greater than grade 1 before starting the study drug.

Who cannot join the trial?

3 criteria

  • Patients who do not have HER2-positive metastatic breast cancer cannot participate. HER2-positive means that the cancer has a protein called HER2 on its surface, which promotes the growth of cancer cells. Metastatic means that the cancer has spread to other parts of the body.
  • Only female patients can participate. Male patients are not eligible.
  • Patients who are considered part of a vulnerable population are not eligible. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

[177Lu]Lu-ABY-271 is a new type of treatment being tested for people with a specific kind of breast cancer called HER2-positive metastatic breast cancer. This treatment involves a special substance that is designed to find and attach to cancer cells in the body. Once it attaches, it delivers a small amount of radiation directly to the cancer cells. The goal is to see if this approach can help treat the cancer by targeting the cancer cells more precisely, while also checking if it is safe and how well people can tolerate it. This treatment is given through an IV, which means it is administered directly into the bloodstream. The study is looking at how this treatment spreads in the body and how it affects both the tumors and important organs.

What is already known about the treatment

[177Lu]Lu-ABY-271 – This medication is administered as a single intravenous (IV) infusion, meaning it is delivered directly into the bloodstream through a vein. It is currently being studied in clinical trials, specifically a phase 1 trial, to determine its safety and how it spreads in the body. The main use being explored is for treating HER2-positive metastatic breast cancer, a type of cancer that has spread to other parts of the body and has a specific protein called HER2. At the molecular level, this medication works by targeting and binding to the HER2 protein on cancer cells, which may help to deliver radiation directly to the cancer cells and limit damage to healthy cells. It falls under the pharmacological classification of radiopharmaceuticals, which are drugs that contain radioactive substances used to treat or diagnose diseases.

Investigated diseases

HER2-positive metastatic breast cancer – This is a type of breast cancer characterized by the overexpression of the human epidermal growth factor receptor 2 (HER2) protein. It begins in the breast tissue and can spread to other parts of the body, such as the bones, liver, lungs, and brain. The progression involves the growth and division of cancer cells that have spread beyond the original tumor site. These cancer cells can invade nearby tissues and form new tumors in other organs. The disease is known for its aggressive nature due to the high levels of HER2 protein, which promotes rapid cell growth. As the cancer advances, it can lead to various symptoms depending on the organs affected by metastasis.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-518360-13-00Protocol codeABY-271-101Estimated enrolment30 patientsSponsorAffibody AB

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