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Study of [177Lu]Lu-NeoB and Capecitabine for Patients with Advanced Breast Cancer Resistant to Hormone Therapy

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 cancer known as metastatic breast cancer, which has specific characteristics: it is estrogen receptor-positive and human epidermal growth factor receptor-2 negative. The study is designed for patients whose cancer has progressed after previous treatments. The treatment being tested involves a combination of two medications: [177Lu]Lu-NeoB, which is given through an infusion into the veins, and capecitabine, which is taken as a tablet by mouth. The purpose of the study is to find the best doses and to see how effective this combination is in treating the cancer.

The study will be conducted in two phases. In the first phase, the focus will be on determining the recommended doses of [177Lu]Lu-NeoB when used with capecitabine. In the second phase, the study will evaluate how well the treatment works in reducing the cancer across different groups of patients. Participants will receive the treatment and be monitored for any side effects and changes in their health. The study will also involve regular imaging tests, such as MRI or CT scans, to assess the cancer's response to the treatment.

Throughout the study, participants will be closely observed to ensure their safety and to gather information on how the treatment affects their cancer. The study aims to provide valuable insights into the potential benefits of using [177Lu]Lu-NeoB with capecitabine for treating this specific type of breast cancer. The results could help in developing more effective treatment options for patients with similar cancer profiles in the future.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    A series of tests may be performed to ensure the participant meets the study criteria, such as imaging tests and blood work.

  2. Step 2

    Treatment phase I

    The first phase of treatment involves determining the recommended doses and dosing regimens of [177Lu]Lu-NeoB in combination with capecitabine.

    Participants receive [177Lu]Lu-NeoB as a solution for infusion, administered intravenously. The exact dosage and frequency are determined during this phase.

    Participants also take capecitabine orally, with the dosage and frequency tailored to individual needs.

  3. Step 3

    Evaluation of treatment response

    Throughout the treatment, regular assessments are conducted to monitor the body's response to the medication.

    These assessments include imaging tests and blood tests to evaluate the effectiveness of the treatment and any side effects.

  4. Step 4

    Treatment phase II

    In the second phase, the focus is on evaluating the anti-tumor activity of the treatment across different doses and regimens.

    Participants continue to receive [177Lu]Lu-NeoB and capecitabine as per the regimen established in Phase I.

  5. Step 5

    Ongoing monitoring

    Participants are monitored for any adverse effects or changes in health status.

    Regular follow-up visits are scheduled to ensure the safety and effectiveness of the treatment.

  6. Step 6

    Completion of trial

    Upon completion of the trial, a final assessment is conducted to evaluate the overall outcomes of the treatment.

    Participants may receive guidance on next steps for their health management based on the trial results.

Who can join the trial?

10 criteria

  • The participant must be an adult, either female or male, who is **18 years or older** at the time of giving consent to join the study.
  • For the first part of the study, female participants must be **postmenopausal**, which means they have stopped having menstrual periods. For the second part, female participants can be either postmenopausal or pre/peri-menopausal, which means they are still having periods or are in the transition phase.
  • The participant must have a confirmed diagnosis of **ER+ breast cancer**, which means the cancer cells have more than 10% of their nuclei showing estrogen receptor positivity.
  • The participant must have **HER2- breast cancer**, which means the cancer does not have high levels of the HER2 protein. This is confirmed by specific tests that show negative results.
  • The participant should not have received more than three previous treatments with hormone therapy for cancer that has spread to other parts of the body. At least one of these treatments should have included a **CDK4/6 inhibitor**, a type of drug that helps stop cancer cells from growing. If the participant has certain genetic mutations, they may have also received a **PARP inhibitor**. If the cancer is HER2-low, they may have received a drug called **Enhertu®**.
  • The participant must have **metastatic breast cancer**, meaning the cancer has spread to other parts of the body, and there must be evidence that the disease has gotten worse after the most recent treatment.
  • The participant must have at least one **measurable lesion**, which is a tumor that can be measured using imaging tests like CT or MRI. If the lesion was previously treated with radiation, it must show signs of getting worse to be counted.
  • The participant must have at least one **target lesion** that shows a specific uptake on imaging tests, indicating the presence of cancer. If the cancer involves the liver or lungs, the imaging must show uptake in at least 50% of the measurable lesions in these organs.
  • The participant must have an **ECOG performance status** of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
  • The participant must have adequate **bone marrow and organ function**, which will be determined by specific laboratory tests.

Who cannot join the trial?

10 criteria

  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with severe heart problems are not eligible.
  • Patients with uncontrolled high blood pressure cannot join the study.
  • Patients with active infections that require treatment are excluded.
  • Patients who have had another type of cancer in the past 5 years, except for certain skin cancers, cannot participate.
  • Patients who have had major surgery within the last 4 weeks are not eligible.
  • Patients who are currently participating in another clinical trial are excluded.
  • Patients with known allergies to the study drugs cannot join the study.
  • Patients with severe liver or kidney problems are not eligible.
  • Patients with a history of certain lung diseases are excluded.
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Investigated drugs

  • [177Lu]Lu-NeoB

    is a medication being studied for its potential to treat certain types of breast cancer. It is used in patients whose cancer has specific characteristics, such as being positive for gastrin-releasing peptide receptors and estrogen receptors, but negative for a protein called human epidermal growth factor receptor-2. This medication is being tested to see how well it works when combined with another drug, especially after other treatments have not been successful.

  • Capecitabine

    is a chemotherapy drug that is used to treat various types of cancer, including breast cancer. In this clinical trial, it is combined with [177Lu]Lu-NeoB to see if the combination is more effective in treating breast cancer that has certain specific characteristics. Capecitabine works by interfering with the growth of cancer cells, slowing down or stopping their spread in the body.

What is already known about the treatment

  • [177Lu]Lu-NeoB

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating metastatic breast cancer. It is specifically targeted at patients with gastrin-releasing peptide receptor-positive, estrogen receptor-positive, and human epidermal growth factor receptor-2 negative breast cancer. The drug works by delivering a radioactive isotope, Lutetium-177, directly to cancer cells, which helps to destroy them. It is classified as a radiopharmaceutical agent. The trials aim to determine the optimal dosing regimen and assess its anti-tumor activity when used in combination with capecitabine.

  • Capecitabine

    This medication is taken orally in the form of tablets and is well-established in medical practice for the treatment of various cancers, including breast cancer. It is used in combination with other treatments, such as [177Lu]Lu-NeoB, to enhance therapeutic effects. Capecitabine is a prodrug that is converted into 5-fluorouracil in the body, which interferes with DNA synthesis in cancer cells, leading to their death. It is classified as an antimetabolite chemotherapy agent. The ongoing clinical trials are exploring its combined use with [177Lu]Lu-NeoB to improve outcomes in patients with specific types of breast cancer.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor that can often be felt as a lump. It typically begins in the ducts or lobules of the breast and can spread to other parts of the body if not managed. The progression of breast cancer can vary, with some types growing slowly and others more rapidly. It may cause changes in breast shape, skin texture, or nipple discharge. The disease can affect both women and men, though it is much more common in women. Early detection and understanding of its progression are crucial for managing the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-506717-21-00Protocol codeCAAA603D12101Estimated enrolment84 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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