Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Palbociclib and Drug Combination for Patients with Hormone Receptor Positive, HER2-Positive Metastatic Breast Cancer

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying metastatic breast cancer, a type of breast cancer that has spread to other parts of the body. The study is investigating the effectiveness and safety of a treatment combination that includes palbociclib, an oral medication, along with anti-HER2 therapy and endocrine therapy. The goal is to see if this combination is better at delaying the progression of the disease compared to just using anti-HER2 therapy and endocrine therapy alone. Participants in the study will receive either the combination treatment or the standard treatment after an initial phase of treatment known as induction treatment.

The study will involve taking medications in the form of capsules or tablets, such as IBRANCE (which contains palbociclib) and other hormone therapies like exemestane, anastrozole, and letrozole. Some treatments, like fulvestrant, triptorelin, leuprorelin, and goserelin, will be given as injections. The study will also include anti-HER2 therapies like trastuzumab and pertuzumab, which are used to target specific proteins on cancer cells. The trial is designed to last for a period of time, during which participants will be monitored for any changes in their condition and any side effects they may experience.

The purpose of this study is to determine if the combination of palbociclib with anti-HER2 and endocrine therapies can provide better outcomes for patients with hormone receptor-positive, HER2-positive metastatic breast cancer. The study will assess how long patients live without their cancer getting worse, as well as overall survival rates and the response to treatment. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and to gather important information about the effectiveness of the treatment.

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

    Joining the study

    Upon joining the study, the patient will be required to sign a Main Informed Consent Form. This document confirms the patient's understanding and agreement to participate in the trial.

    A screening process will be conducted to ensure eligibility, which includes a review of medical history and current health status.

  2. Step 2

    Initial assessment

    An initial assessment will be performed to establish baseline health metrics. This may include blood tests, imaging studies, and other necessary evaluations.

    The patient must provide a tumor tissue sample, if feasible, for further analysis.

  3. Step 3

    Treatment phase

    The treatment phase involves the administration of medications. The patient will receive a combination of palbociclib and anti-HER2 therapy along with endocrine therapy.

    Palbociclib is available in capsule form and is taken orally. Dosages may vary, including 75 mg, 100 mg, or 125 mg, depending on the specific treatment plan.

    Anti-HER2 therapies such as trastuzumab and pertuzumab are administered through injections or infusions.

    Endocrine therapies may include medications like letrozole, exemestane, or anastrozole, which are taken orally.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring will be conducted to assess the patient's response to treatment. This includes scheduled visits for physical examinations, laboratory tests, and imaging studies.

    The patient's health and any side effects experienced will be closely monitored to ensure safety and effectiveness of the treatment.

  5. Step 5

    End of treatment

    Upon completion of the treatment phase, a final assessment will be conducted to evaluate the overall response to the therapy.

    The patient will be informed about the results and any further steps or follow-up care that may be necessary.

Who can join the trial?

18 criteria

  • You must sign a form called the Preliminary Screening Informed Consent Form before any study-related tests or procedures.
  • You should be able to swallow pills and not have any condition that affects how your body absorbs medication.
  • If you are a woman who can have children, you need a negative pregnancy test within 7 days before starting the study. If you are postmenopausal or have had certain surgeries like removal of ovaries or uterus, you may not need this test.
  • Both men and women in the study must use effective birth control during the study and for a period after the last treatment. This means using one highly effective method or two effective methods together.
  • Any side effects from previous cancer treatments should be resolved to a mild level, except for hair loss or other non-risky side effects. You can start the study 12 weeks after your last chemotherapy dose.
  • You must be willing and able to attend scheduled visits, follow the treatment plan, and undergo tests and procedures required by the study.
  • If you had previous treatments, you should have been free of cancer for at least 6 months after completing anti-HER2 therapy before being diagnosed with metastatic cancer.
  • You should have completed a specific type of chemotherapy with anti-HER2 therapy for metastatic breast cancer before joining the study. This includes a minimum of 4 cycles if you had significant side effects, but ideally 6 cycles. You can join the study immediately after finishing this treatment or within 12 weeks.
  • If you have cancer that has spread to the brain but have no symptoms, you can join if you meet certain conditions, like having no bleeding in the brain and not needing medication for seizures.
  • Your blood tests should show certain levels: white blood cells (neutrophils) at least 1,000/mm³, platelets at least 100,000/mm³, and hemoglobin at least 10g/dL.
  • You must be at least 18 years old.
  • Your liver and kidney function should be within certain limits, as shown by blood tests.
  • Your heart function should be at least 50% as measured by specific tests like ECHO or MUGA.
  • You must have confirmed invasive breast cancer that has spread or cannot be removed or treated with radiation to cure it.
  • Your cancer must be HER2 positive and hormone receptor positive, which means certain proteins are present in your cancer cells.
  • You must agree to provide a sample of your tumor tissue for testing, either from a previous surgery or a recent biopsy if possible.
  • You need to sign the Main Informed Consent Form before any study-related tests or procedures.
  • Your general health should be good, as measured by a scale called ECOG performance status, which should be 0 or 1.

Who cannot join the trial?

5 criteria

  • Patients who have already received treatment beyond the initial treatment for their metastatic breast cancer cannot participate. Metastatic breast cancer means the cancer has spread to other parts of the body.
  • Patients who are not diagnosed with hormone receptor-positive, HER2+ breast cancer are excluded. Hormone receptor-positive means the cancer cells grow in response to hormones. HER2+ means the cancer has a protein that promotes the growth of cancer cells.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
  • Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.
  • Both male and female patients can participate, but they must meet all other criteria.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Palbociclib

    is a medication used in this trial to help treat metastatic breast cancer. It works by blocking certain proteins in cancer cells, which can slow down or stop the growth of the cancer. In this study, it is combined with other therapies to see if it can improve the treatment outcomes for patients with hormone receptor-positive, HER2-positive breast cancer.

  • Anti-HER2 Therapy

    refers to treatments that specifically target the HER2 protein, which can promote the growth of cancer cells. By blocking this protein, anti-HER2 therapies can help slow or stop the progression of the cancer. This therapy is used in combination with other treatments in the trial to evaluate its effectiveness in managing breast cancer.

  • Endocrine Therapy

    is a treatment that targets hormone receptor-positive breast cancer by interfering with the cancer's ability to use hormones like estrogen or progesterone to grow. This therapy is often used to help slow down or stop the growth of hormone-sensitive tumors. In this trial, it is combined with other therapies to assess its role in treating metastatic breast cancer.

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 for its effectiveness in treating hormone receptor-positive, HER2-positive metastatic breast cancer. The main therapeutic indication is to prolong progression-free survival in patients with this type of breast cancer. At the molecular level, palbociclib works by inhibiting cyclin-dependent kinases 4 and 6 (CDK4/6), which are proteins that help control cell division. It is classified as a CDK4/6 inhibitor in pharmacology.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably. It often begins in the ducts or lobules of the breast. As the disease progresses, it can spread to nearby tissues and lymph nodes. In some cases, it may metastasize to other parts of the body, such as bones, liver, or lungs. The progression can vary greatly among individuals, with some experiencing slow growth and others more rapid advancement. Hormone receptor-positive, HER2-positive breast cancer is a subtype that can influence the growth rate and spread of the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513540-29-00Protocol codeAFT-38Estimated enrolment518 patientsSponsorAlliance Foundation Trials LLC

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.