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Preoperative Elacestrant and PULSAR Adaptive Radiotherapy for Hormone Receptor-Positive, HER2-Negative Breast Cancer: A Study for Patients with Stage II-III Disease

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What is this trial about?

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

This phase II study focuses on Hormonal Receptor (HR)-positive HER2 negative breast cancer patients with cancer that has spread to lymph nodes (stage II-III). The study will evaluate a combination treatment consisting of Elacestrant (a medication) and PULSAR adaptive radiotherapy given before surgery (preoperative). The purpose is to assess how safe and tolerable this combination therapy is for patients with this specific type of breast cancer.

Patients in this study will receive both the medication Elacestrant and PULSAR radiotherapy before undergoing surgery to remove the tumor. During the study, doctors will monitor for side effects and evaluate how well the treatment works by examining the breast tissue and lymph nodes removed during surgery. They will look for the absence of cancer cells, which is called a pathological complete response, or measure any remaining cancer using the residual cancer burden assessment.

The study will also track patients' outcomes over time, including whether the cancer returns, how long patients remain free of invasive disease, and overall survival. Additionally, researchers will analyze tissue and blood samples to better understand how the treatment affects the cancer at a cellular level.

The research process

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

  1. Step 1

    Screening and Baseline Assessment

    Your eligibility for the study will be confirmed through various tests that check your bone marrow function, liver function, kidney function, and tumor characteristics.

    A breast MRI will be performed to ensure your primary breast tumor is at least 20mm in size.

    Blood samples will be collected to assess your overall health status and to collect baseline measurements.

    A diagnostic biopsy of your tumor will be taken for initial assessment and for later comparison with post-treatment samples.

  2. Step 2

    Treatment Phase

    You will receive two main treatments: Elacestrant (an oral medication) and PULSAR adaptive radiotherapy (a specialized form of radiation treatment).

    The treatment is considered neoadjuvant, which means it's given before surgery with the goal of shrinking the tumor.

    Blood samples will be collected at the start of treatment, after 12 weeks of treatment, and at the end of treatment to analyze circulating tumor DNA (ctDNA).

    Your tumor response will be monitored throughout treatment using imaging techniques.

  3. Step 3

    Surgery

    After completing the neoadjuvant treatment, you will undergo surgery to remove the remaining tumor tissue and affected lymph nodes.

    The removed tissue will be thoroughly examined by pathologists to determine how well the treatment worked.

    They will check for pathological complete response (pCR), which means no invasive cancer cells remain in the breast tissue or lymph nodes.

    They will also assess residual cancer burden (RCB), which measures how much cancer remains after treatment.

  4. Step 4

    Post-Surgery Follow-up

    You will attend regular follow-up appointments for at least 12 months after starting treatment.

    During these visits, your doctors will monitor for any signs of cancer recurrence, either locally or in distant parts of your body.

    Additional blood tests and imaging may be performed to assess your ongoing health status.

    Any side effects or adverse events will continue to be recorded and managed.

  5. Step 5

    Study Assessments

    Throughout the study, your doctors will record any adverse events (side effects or new health problems) you experience.

    Regular laboratory tests will monitor your blood counts, liver function, and kidney function.

    Imaging studies will assess how your tumor responds to treatment.

    The study will track your event-free survival (time without cancer progression, recurrence, or death) and overall survival.

    Researchers will compare tissue samples from before and after treatment to understand how the treatment affected your cancer at the molecular level.

Who can join the trial?

15 criteria

  • You must have hormone receptor-positive (HR+), HER2-negative breast cancer that has spread to lymph nodes but not to distant parts of the body (stage II-III).
  • You must be eligible for treatment before surgery (neoadjuvant treatment).
  • You must be at least 18 years old when you sign the consent form.
  • You must be post-menopausal if female, or male.
  • You must have a life expectancy of at least 12 months according to the doctor.
  • You must have an ECOG performance status of 2 or less (a measure of how well you can perform daily activities).
  • You must be able to undergo CT/PET scans and MRI/Ultrasound imaging for diagnosis and follow-up.
  • You must have adequate kidney function as determined by blood tests.
  • Your breast tumor must measure at least 20mm on a breast MRI.
  • You must have adequate liver function as shown by blood tests.
  • Your blood clotting tests must be within acceptable ranges.
  • You must have adequate bone marrow function (sufficient blood cell counts).
  • Your tumor must be accessible for biopsy and surgery.
  • You must be able to understand and follow instructions during the trial.
  • You must be able and willing to give written informed consent.

Who cannot join the trial?

10 criteria

  • You cannot participate if you don't have hormone receptor-positive (HR-positive), HER2-negative breast cancer that has spread to lymph nodes but not to distant parts of the body.
  • You are not eligible if your breast cancer is not classified as clinical stage II-III, which refers to the size of the tumor and extent of spread to nearby tissues.
  • You cannot join if you are not eligible for neoadjuvant treatment (therapy given before main treatment, usually surgery).
  • You may be excluded if you have previously received radiation therapy to the chest area.
  • You cannot participate if you have metastatic disease (cancer that has spread to distant organs).
  • If you have significant heart problems, you may not be eligible due to potential risks.
  • You may be excluded if you have certain medical conditions that could interfere with the study treatment or results.
  • If you are pregnant or breastfeeding, you cannot participate in this study.
  • You cannot join if you are currently participating in another clinical trial that could interfere with this study.
  • If you have allergies to the study medications (Elacestrant or components), you will not be eligible.
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Investigated drugs

Medications and therapies in this clinical trial: Elacestrant is a medication that works by blocking estrogen receptors in breast cancer cells. It is designed to treat hormone receptor-positive, HER2-negative breast cancer by preventing estrogen from stimulating cancer cell growth. PULSAR adaptive radiotherapy is a specialized form of radiation treatment that delivers radiation in precise, adaptable doses to target cancer cells while minimizing damage to surrounding healthy tissue. This technique adjusts the radiation delivery based on the patient's specific tumor characteristics.

What is already known about the treatment

Elacestrant – A medication administered orally as a tablet, Elacestrant is a selective estrogen receptor degrader (SERD) that has been approved for treating certain types of hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. It works by binding to estrogen receptors and causing them to degrade, thereby blocking estrogen-driven tumor growth. Elacestrant represents a significant advancement in breast cancer treatment as it provides an oral alternative to traditional injectable SERDs and has shown effectiveness in patients with specific mutations that cause resistance to other hormonal therapies.

Investigated diseases

Breast Cancer (BC) Breast cancer is a malignancy that develops in breast tissues, typically in the ducts or lobules. The disease begins when cells in the breast grow abnormally and form a tumor. In HR-positive (hormone receptor-positive) breast cancer, the cancer cells have receptors for estrogen or progesterone, which can promote cancer growth. HER2-negative means the cancer cells don't have excessive HER2 protein, which affects treatment approaches. Node-positive indicates the cancer has spread to nearby lymph nodes, suggesting a more advanced stage of disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520762-22-00Protocol codeHELP TrialEstimated enrolment21 patientsSponsorFondazione Radioterapia Oncologica Onlus

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