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Study of Palbociclib as an Alternative to Chemotherapy for Older Patients with High-Risk Early Breast Cancer

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 the treatment of localized ER-positive breast cancer in older patients. The study is exploring the use of a medication called palbociclib, which is being considered as an alternative to traditional chemotherapy. Palbociclib is a type of drug known as an inhibitor of cyclin-dependent kinases (CDK) 4 and 6, which are proteins that help control cell division. The trial aims to determine if using palbociclib along with at least five years of hormone therapy can be as effective as chemotherapy followed by hormone therapy in preventing the return of cancer.

Participants in the study will receive palbociclib for two years as part of their treatment plan. The study will compare the outcomes of patients receiving this treatment with those receiving standard chemotherapy. The trial will monitor the patients over several years to assess the effectiveness of the treatment in preventing cancer recurrence and to evaluate the overall survival rates. The study will also track any side effects experienced by the participants and how these might affect their quality of life.

The trial is designed for patients who have undergone surgery for their breast cancer and are at high risk of the cancer returning. It is specifically targeting older patients, as they may have different treatment needs compared to younger individuals. The study will help determine if palbociclib can offer a viable alternative to chemotherapy, potentially providing a treatment option with fewer side effects for this group of patients.

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

    Joining the study

    Upon joining the study, the patient will be assessed to ensure they meet the eligibility criteria, including age, health status, and previous surgery details.

    The patient must have completed a geriatric assessment and have the ability to take oral medication.

  2. Step 2

    Initial treatment phase

    The patient will begin treatment with palbociclib, an oral medication, as an alternative to chemotherapy. The dosage and form will be determined by the healthcare provider.

    This phase includes the administration of palbociclib for a duration of 2 years, alongside a 5-year endocrine therapy.

  3. Step 3

    Radiation therapy

    If indicated, radiation therapy will be administered. This should start within 13 weeks after the last surgery.

    Endocrine therapy can begin during or after radiation therapy but must start no later than 4 weeks after the last radiotherapy session.

  4. Step 4

    Ongoing treatment and monitoring

    The patient will continue with the prescribed endocrine therapy for a total of 5 years.

    Regular monitoring will occur to assess the patient's response to treatment and manage any side effects.

  5. Step 5

    Follow-up assessments

    The patient will undergo periodic assessments to evaluate their health status and the effectiveness of the treatment.

    These assessments include quality of life questionnaires and geriatric assessments at specified intervals over the course of the study.

  6. Step 6

    Completion of the study

    The study is expected to conclude by October 2026, with final evaluations to determine the long-term outcomes of the treatment.

Who can join the trial?

21 criteria

  • Participants must be women or men with early invasive breast cancer at stage II or III, as classified by a specific cancer staging system.
  • The treating doctor and patient must agree that chemotherapy is needed and possible, based on factors like tumor size, lymph node involvement, overall health, and other tests.
  • Chemotherapy using specific drugs called anthracycline and taxanes should not be needed or possible, according to the doctor.
  • Participants must be 70 years old or older.
  • Participants should have a WHO Performance status of 0-2, which means they are in good enough health to carry out daily activities.
  • A G8 geriatric assessment, which is a health check for older adults, must be completed within 3 weeks before joining the study.
  • Participants must agree to take part in additional research, including giving blood samples during the study.
  • Participants must be able to swallow pills and not have any condition that affects how their body absorbs medicine.
  • Participants must have had surgery to remove the breast tumor, with no remaining cancer cells, within 12 weeks before joining the study.
  • Participants should have recovered from any surgery side effects, with no ongoing wound healing issues.
  • Participants should be willing to have radiation therapy if recommended by their doctor. The timing of radiation and other treatments will be guided by specific rules.
  • Participants must have normal organ function, shown by specific blood test results taken within 3 weeks before joining the study. These include:
    • Hemoglobin level of at least 9 g/dL
    • White blood cell count (neutrophils) of at least 1500/mm3
    • Platelet count of at least 100,000/mm3
    • Total bilirubin level within normal limits, or slightly higher if they have a condition called Gilbert's Syndrome
    • Kidney function (GFR) of at least 30 ml/min
    • Liver enzymes (SGOT, SGPT, alkaline phosphatase) within normal limits
    • Men in the study should consider sperm preservation before treatment, as fertility may be affected. They must use effective birth control methods with partners who can become pregnant during and after treatment.
    • Participants must provide signed, written consent to join the study.
    • The breast cancer must be confirmed as ER+ (estrogen receptor positive) and HER2- (HER2 negative) based on lab tests.
    • If participants have multiple breast tumors, all tumors must meet the criteria for ER and HER2 status.

Who cannot join the trial?

8 criteria

  • Patients with breast cancer that is not ER+. ER+ means the cancer cells grow in response to the hormone estrogen.
  • Patients with breast cancer that is HER2+. HER2+ means the cancer cells have more of a protein that promotes the growth of cancer cells.
  • Patients who are not in the age range specified for the trial. The trial is for older patients.
  • Patients who are not willing or able to follow the trial procedures and treatments.
  • Patients who have other medical conditions that might interfere with the trial treatments or outcomes.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have had certain treatments for breast cancer before, which might affect the trial results.
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Investigated drugs

  • Palbociclib

    is a medication used in this trial as an alternative to traditional chemotherapy. It is being tested to see if it can effectively treat elderly patients with high-risk early breast cancer. Palbociclib works by inhibiting certain proteins that are involved in the growth and division of cancer cells, potentially slowing down or stopping the progression of the disease.

  • Endocrine Therapy

    is a treatment used in combination with palbociclib in this trial. It involves the use of medications that block or lower the amount of hormones in the body, particularly estrogen, which can fuel the growth of certain types of breast cancer. This therapy aims to reduce the risk of cancer returning after initial treatment.

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 as an alternative to chemotherapy for elderly patients with high-risk ER-positive, HER2-negative early breast cancer. Palbociclib is primarily used to treat certain types of breast cancer by inhibiting proteins called cyclin-dependent kinases 4 and 6 (CDK4/6), which are involved in cell division. By blocking these proteins, palbociclib helps slow down the growth of cancer cells. It is classified as a CDK4/6 inhibitor in pharmacology.

Investigated diseases

Localized ER+ Breast Cancer – This type of breast cancer is characterized by the presence of estrogen receptors on the surface of the cancer cells, which means the cancer cells may receive signals from estrogen that could promote their growth. It is considered localized when it has not spread beyond the breast or the nearby lymph nodes. The progression of this cancer can vary, but it typically involves the growth of the tumor within the breast tissue. Over time, if not managed, it may spread to nearby lymph nodes or other parts of the body. The disease is often detected through routine screening or when symptoms such as a lump in the breast are noticed.
Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase IITrial ID2023-505223-31-00Protocol codeEORTC-1745-ETF-BCGEstimated enrolment373 patientsSponsorEuropean Organisation For Research And Treatment Of Cancer

sourced from the EU Clinical Trials Register and site verification

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