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Study on Palbociclib and Endocrine Therapy for Patients with HR+/HER2- Early Breast Cancer

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 hormone receptor-positive (HR+) / human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. The study is investigating the effects of a medication called Palbociclib, which is taken in the form of capsules. Palbociclib is being tested in combination with standard hormone therapy, which is a common treatment for this type of breast cancer. The purpose of the study is to determine if adding Palbociclib to the usual hormone therapy can improve patient outcomes compared to hormone therapy alone.

Participants in the study will be randomly assigned to one of two groups. One group will receive the standard hormone therapy alone, while the other group will receive both the standard hormone therapy and Palbociclib. The treatment with Palbociclib will last for two years, while the hormone therapy will continue for at least five years. The study will monitor participants over time to see how well they do with each treatment approach, focusing on how long they remain free from invasive breast cancer.

The trial aims to provide valuable information about the potential benefits of combining Palbociclib with hormone therapy for patients with HR+/HER2- early breast cancer. By comparing the two treatment groups, researchers hope to learn more about the effectiveness and safety of this combination therapy. The study is expected to continue until the end of 2028, allowing for a comprehensive evaluation of the long-term outcomes for participants.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be randomly assigned to one of two groups. One group will receive the medication palbociclib in addition to standard hormone therapy, while the other group will receive only the standard hormone therapy.

    The patient must have signed an informed consent form before any study-specific procedures begin.

  2. Step 2

    Medication administration

    If assigned to the group receiving palbociclib, the patient will take this medication orally in the form of capsules. The treatment with palbociclib will last for 2 years.

    The standard hormone therapy will continue for at least 5 years. This therapy may include medications such as tamoxifen or aromatase inhibitors (letrozole, anastrozole, or exemestane).

  3. Step 3

    Monitoring and follow-up

    Throughout the trial, the patient's health will be monitored regularly to assess the effectiveness of the treatment and to check for any side effects.

    The primary goal is to compare the time during which the patient remains free from invasive disease between the two groups.

  4. Step 4

    Completion of the trial

    The trial is expected to conclude by the end of 2028. At this point, the data collected will be analyzed to determine the outcomes of the study.

    The patient will continue to be monitored for any long-term effects or recurrence of the disease.

Who can join the trial?

20 criteria

  • Must sign a form agreeing to participate in the study before any study-related tests or procedures.
  • Women who can have children must have a negative pregnancy test within 7 days before starting the study. They must also use reliable birth control during the study and for 6 months after the last treatment if they are in the treatment group. Men in the study must also use reliable birth control.
  • Must have finished any previous chemotherapy or biological therapy and have recovered from any side effects as assessed by a doctor.
  • Must have finished any previous radiation therapy and have recovered from any side effects as assessed by a doctor.
  • Must have recovered from any surgery-related side effects with no ongoing wound healing issues as assessed by a doctor.
  • Must be starting or have already started hormone treatment after surgery. Randomization must occur within 12 months of diagnosis and within 6 months of starting hormone treatment. Can be taking tamoxifen or aromatase inhibitors. Premenopausal patients and men can use LHRH agonists.
  • Must have a certain level of white blood cells called neutrophils (at least 1,500 per mm3).
  • Must have a certain level of platelets (at least 100,000 per mm3).
  • Must have a certain level of hemoglobin (at least 10 g/dL).
  • Must have normal levels of bilirubin, a substance made by the liver, unless they have a condition called Gilbert's Syndrome.
  • Must have normal levels of liver enzymes called AST and ALT.
  • Must be at least 18 years old.
  • Must have normal kidney function, measured by serum creatinine or creatinine clearance.
  • Can be premenopausal or postmenopausal women or men with certain stages of early breast cancer.
  • Can have multiple tumors in one or both breasts, but all tumors must meet specific criteria for hormone receptors and HER2 status.
  • Must have breast cancer that is hormone receptor positive (ER+ and/or PR+) and HER2 negative. Tests must be done according to guidelines.
  • Must have had proper breast surgery for the current cancer.
  • Must provide a sample of tumor tissue to a central repository before starting the study.
  • Must have a performance status of 0-1, meaning they are fully active or have some symptoms but can carry out light work.
  • Must be able to swallow and keep down oral medication without any condition that affects absorption in the stomach or intestines.

Who cannot join the trial?

7 criteria

  • Patients who have not been diagnosed with **HR+/HER2- early breast cancer**. This means the cancer is hormone receptor-positive and does not have too much of a protein called HER2.
  • Patients who have not had their cancer confirmed by a test called a **histological test**, which looks at tissue under a microscope.
  • Patients who are not able to undergo at least 5 years of **endocrine therapy**, which is a treatment that blocks or lowers the amount of hormones in the body to slow down or stop cancer growth.
  • Patients who cannot take **palbociclib**, a medication used to treat certain types of breast cancer, for 2 years.
  • Patients who are not within the specified age range for the study.
  • Patients who are not willing or able to follow the study procedures and requirements.
  • Patients who are part of a vulnerable population that the study cannot safely include.
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Investigated drugs

  • Palbociclib

    is a medication used in this trial to treat early breast cancer. It works by inhibiting certain proteins in cancer cells, which can slow down or stop their growth. In this study, it is being tested in combination with standard endocrine therapy to see if it improves outcomes for patients with hormone receptor-positive, HER2-negative early breast cancer.

  • Endocrine Therapy

    is a standard treatment for hormone receptor-positive breast cancer. It involves using medications that block or lower the amount of hormones in the body, which can help slow or stop the growth of cancer cells that rely on these hormones. In this trial, endocrine therapy is used alone or in combination with palbociclib to evaluate its effectiveness in preventing cancer recurrence.

What is already known about the treatment

Palbociclib – This medication is administered orally in the form of capsules. It is currently being studied in clinical trials to assess its effectiveness when added to standard endocrine therapy for early-stage hormone receptor-positive, HER2-negative breast cancer. The main therapeutic indication is to improve outcomes in patients with this type of breast cancer. At the molecular level, palbociclib works by inhibiting certain proteins called cyclin-dependent kinases, which are involved in cell division, thereby slowing down the growth of cancer cells. It is classified as a targeted cancer therapy.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably. It can begin in different parts of the breast, most commonly in the ducts or lobules. The disease is classified into various types, such as hormone receptor-positive (HR+) and HER2-negative (HER2-), which influence its behavior and progression. In its early stages, breast cancer may not cause noticeable symptoms, but as it progresses, it can lead to changes in breast shape, lumps, or skin texture. The progression of breast cancer can vary, with some types growing slowly and others more rapidly. Early detection and understanding of its specific type are crucial for managing its progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514841-12-00Protocol codeAFT-05/ABCSG-42/BIG_Estimated enrolment6 482 patientsSponsorABCSG GmbH

sourced from the EU Clinical Trials Register and site verification

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