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Study of palbociclib with hormone therapy versus hormone therapy alone in patients with recurrent hormone receptor-positive/HER2-negative breast cancer after surgery

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 study focuses on patients with hormone receptor-positive, HER2-negative breast cancer who have experienced a return of cancer in the same area after previous treatment (known as isolated locoregional recurrence). The study will test whether adding the medication palbociclib (also known as IBRANCE) to standard hormone therapy works better than hormone therapy alone.

The main purpose is to determine if using palbociclib together with hormone therapy for 3 years can help prevent the cancer from returning compared to using only hormone therapy. Palbociclib belongs to a group of drugs called CDK4/6 inhibitors, which work by blocking certain proteins that help cancer cells grow.

During the study, patients will receive either palbociclib tablets or capsules (at doses of 75 mg, 100 mg, or 125 mg) along with their regular hormone therapy, or they will receive only hormone therapy. The treatment will continue for up to three years, and doctors will monitor how well the treatment works and check for any side effects.

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

    Initial qualification

    You will undergo tests to confirm that your breast cancer recurrence is hormone receptor positive and HER2-negative.

    Your doctor will verify that the cancer recurrence is located in the breast, chest wall, or lymph nodes.

    The surgical removal of the recurrent tumor must be completed within 6 months before starting the study.

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of two treatment groups:

    Group 1: Palbociclib (IBRANCE) tablets or capsules plus hormone therapy

    Group 2: Hormone therapy alone

  3. Step 3

    Treatment period

    The treatment will continue for 3 years.

    If assigned to Group 1, you will take palbociclib in one of the following forms:

    - Film-coated tablets: 75 mg, 100 mg, or 125 mg

    - Hard capsules: 75 mg, 100 mg, or 125 mg

    All medications are taken by mouth.

    You will also receive hormone therapy for at least 3 years.

  4. Step 4

    Monitoring

    Regular check-ups will monitor:

    - Signs of cancer recurrence

    - Side effects of treatment

    - Overall health status

    Blood tests will check your blood count, kidney, and liver function.

  5. Step 5

    Follow-up period

    The study continues until December 2026.

    Your doctor will monitor for:

    - Return of breast cancer

    - New cancers

    - Overall health status

Who can join the trial?

11 criteria

  • Age 18 years or older
  • Must have breast cancer that has returned locally (in the breast, chest wall, or nearby lymph nodes) that was confirmed through tissue examination
  • The returning cancer must be hormone receptor-positive (responds to hormones) and HER2-negative (does not have high levels of HER2 protein)
  • Must have completed surgical removal of the returning cancer within 6 months before joining the study
  • If radiation therapy was given, it must have been completed at least 2 weeks before joining the study
  • Must have good overall physical function (ECOG status 0 or 1, meaning able to perform daily activities with minimal assistance)
  • Must have normal blood, kidney, and liver function test results
  • Must be willing to provide tumor tissue samples for laboratory examination
  • Must be either planning to start or already taking hormone therapy for the returning cancer
  • Must be able and willing to provide written informed consent
  • Both men and women may participate

Who cannot join the trial?

15 criteria

  • Prior treatment with CDK4/6 inhibitors (a type of targeted cancer therapy)
  • Presence of distant metastases (cancer that has spread to other parts of the body)
  • Current pregnancy or breastfeeding
  • Uncontrolled heart conditions or significant heart disease
  • Active or untreated brain metastases (cancer spread to the brain)
  • Severe liver problems
  • Known allergic reactions to the study medications
  • Participation in another clinical trial within the last 30 days
  • Major surgery within 4 weeks before starting the study treatment
  • Active, uncontrolled infections
  • Other types of cancer within the last 5 years (except adequately treated non-melanoma skin cancer or cervical cancer in situ)
  • Any condition that would make it unsafe to participate in the study according to the physician's assessment
  • Unable to swallow oral medications
  • History of non-compliance with medical treatments
  • Psychiatric conditions that could interfere with study participation
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Investigated drugs

  • Palbociclib

    is a medication that works by blocking certain proteins that help cancer cells grow and divide. It is used to treat hormone receptor-positive breast cancer. In this trial, it is being studied in combination with hormone therapy for patients who have had a recurrence of breast cancer in the same area.

  • Endocrine therapy

    (also known as hormone therapy) is a treatment that blocks or lowers the amount of hormones in the body to stop or slow down the growth of hormone-sensitive breast cancer cells. This type of therapy can include different medications that either block hormones or stop the body from producing them.

What is already known about the treatment

  • Palbociclib

    A targeted oral medication used in breast cancer treatment, specifically for hormone receptor-positive (HR+) and HER2-negative breast cancer cases. This drug belongs to the class of CDK4/6 inhibitors and works by blocking specific proteins (cyclin-dependent kinases 4 and 6) that promote cancer cell growth, effectively slowing down or stopping cancer cell multiplication. Palbociclib is administered in tablet form and is typically used in combination with endocrine therapy to enhance treatment effectiveness. The medication has shown significant promise in clinical trials for treating breast cancer recurrence, particularly in cases of isolated locoregional recurrence (ILRR).

  • Endocrine Therapy

    A hormonal treatment approach that either blocks the body's ability to produce hormones or interferes with how hormones behave in the body, specifically targeting hormone receptor-positive breast cancer. This therapy can be administered in various forms, including oral medications (such as tamoxifen or aromatase inhibitors) or as injections, and works by preventing hormones from stimulating cancer cell growth. Endocrine therapy is a well-established standard treatment in breast cancer management, particularly effective in hormone receptor-positive cases, and is often prescribed for extended periods to prevent cancer recurrence.

Investigated diseases

  • Breast Cancer (HR-positive, HER2-negative)

    A type of breast cancer characterized by the presence of hormone receptors (HR) and absence of human epidermal growth factor receptor 2 (HER2) on cancer cells. This cancer begins when abnormal cells in the breast tissue start growing uncontrollably. It can initially develop in the breast tissue and may spread to nearby lymph nodes. The cancer cells in this type respond to hormones like estrogen and progesterone, which can influence their growth. When this type of breast cancer returns after initial treatment in the same area or nearby regions, it is called locoregional recurrence.

  • Isolated Locoregional Recurrence (ILRR) of Breast Cancer

    A condition where breast cancer returns in the area where the original cancer was located or in nearby lymph nodes, after a period of remission. This recurrence is limited to the local area and nearby regions, without evidence of spread to distant parts of the body. The recurrent tumor appears in the chest wall, skin, or lymph nodes near the original cancer site. This condition develops after the completion of initial treatment for breast cancer.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510776-20-00Protocol codeIBCSG 59-19Estimated enrolment400 patientsSponsorETOP IBCSG Partners Foundation

sourced from the EU Clinical Trials Register and site verification

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