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Study on Personalized Treatment for High-Risk Breast Cancer Using Palbociclib, Olaparib, and Pertuzumab in Patients with Advanced Disease

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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 breast cancer, a condition where cells in the breast grow uncontrollably. The trial aims to explore how different treatments can be personalized for individuals with high-risk breast cancer. The study will use several medications, including IBRANCE (available in 75 mg, 100 mg, and 125 mg hard capsules), which contains the active substance palbociclib. Palbociclib is a type of medication known as a CDK 4/6 inhibitor, which helps to stop cancer cells from growing. Another medication used in the study is Lynparza (150 mg film-coated tablets), which contains olaparib, a PARP-inhibitor that helps repair damaged DNA in cancer cells. Additionally, Perjeta (420 mg concentrate for solution for infusion) containing pertuzumab will be used, which is a type of protein that targets specific cancer cells.

The purpose of this study is to identify molecular markers that can predict how well a patient will respond to treatment and their survival outcomes. Participants will receive one or more of these medications, or a placebo, depending on their specific condition and treatment plan. The study will involve regular monitoring and assessments to track the progress of the disease and the effectiveness of the treatment. Participants will take the medications orally or through infusion, depending on the type of medication they are assigned. The trial will also involve taking biopsies, which are small samples of tissue, to study changes in the cancer cells during treatment.

The trial will last for several years, with participants receiving treatment for varying periods depending on their specific treatment plan. The study will help researchers understand how genetic and other factors influence the effectiveness of personalized treatments for breast cancer. By analyzing changes in tumor tissue and genetic material, the study aims to improve treatment strategies and outcomes for patients with high-risk breast cancer. The ultimate goal is to provide more effective and tailored treatment options for individuals with this condition.

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 trial

    Upon joining the trial, you will be required to provide written informed consent. This is a document that confirms you understand the trial and agree to participate.

    You will undergo initial assessments to confirm eligibility, including radiology exams such as CT scans and bone scans, to ensure there are no distant metastases.

  2. Step 2

    Treatment initiation

    Once eligibility is confirmed, treatment will begin. The treatment involves taking medications that are personalized based on your specific type of breast cancer.

    You may be prescribed IBRANCE in the form of hard capsules, which are taken orally. The dosage could be 75 mg, 100 mg, or 125 mg, depending on your specific treatment plan.

    Another medication, Lynparza, is available as 150 mg film-coated tablets, also taken orally.

    In some cases, Perjeta may be administered as a 420 mg solution for infusion, which means it is given through a vein.

  3. Step 3

    Treatment schedule

    The frequency and duration of medication administration will be determined by your healthcare provider based on your treatment plan.

    Regular follow-up appointments will be scheduled to monitor your response to the treatment and adjust dosages if necessary.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, you will undergo regular assessments to monitor the effectiveness of the treatment and any side effects.

    These assessments may include blood tests, imaging studies, and physical examinations.

  5. Step 5

    Completion of treatment

    At the end of the treatment period, final assessments will be conducted to evaluate the overall response to the therapy.

    You may be asked to participate in follow-up visits to monitor long-term outcomes and any potential late side effects.

Who can join the trial?

11 criteria

  • Must have breast cancer that has not been treated before and confirmed by a test called a biopsy. The cancer should be larger than 4 cm, or if it is a specific type called HER2 positive or triple negative, it should be larger than 2 cm.
  • Must not have any psychological, family, social, or location issues that would make it hard to follow the study rules and schedule.
  • Must give written permission to participate in the study, following local and national rules.
  • For certain study groups (B-H), blood tests must show: 1) Neutrophils (a type of white blood cell) greater than 1.5 x 109/L, 2) Platelets (cells that help blood clot) greater than 100 x 109/L, 3) Bilirubin (a substance made by the liver) less than 2 times the normal limit, unless you have a condition called Gilbert's syndrome, 4) Serum creatinine (a measure of kidney function) less than 1.5 times the normal limit, 5) ALT and Alk Phos (ALP) (liver enzymes) less than 2.5 times the normal limit.
  • Must have a WHO performance status of 0-1, which means you are fully active or have some symptoms but can still do light work.
  • Must know the status of certain tumor markers: ER, PGR, HER2, and TP53.
  • Must know the percentage of a tumor marker called Ki67 if certain other markers (ER/PGR) are greater than 50% and TP53 is normal.
  • Must not have suspected distant metastasis, which means the cancer has not spread to other parts of the body. This will be checked with scans after you agree to join the study.
  • Must be older than 18 years.
  • Must have breast cancer that can be measured by scans, according to a standard called RECIST.
  • Must have certain scans (CT of the chest/abdomen and a bone scan) done within 28 days before joining the study.

Who cannot join the trial?

5 criteria

  • Patients with any other type of cancer besides breast cancer cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
  • Patients who are part of a vulnerable population, which means groups that may need special protection, cannot participate.
  • Patients who do not meet the specific health conditions required for the study cannot participate.
  • Patients who are unable to follow the study procedures or attend required visits cannot participate.
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Investigated drugs

  • Carboplatin

    is a chemotherapy medicine used in the treatment of various types of cancer, including breast cancer. It works by damaging the DNA in cancer cells, so that these cells can no longer divide and grow. This medicine is usually given through an infusion into a vein.

  • Doxorubicin

    is a powerful chemotherapy medicine that belongs to the anthracycline group. It is used to treat various forms of cancer, including breast cancer. The medicine works by damaging the DNA in cancer cells and preventing them from dividing. It is given through an infusion and can affect the heart, which is why heart function is closely monitored during treatment.

  • Cyclophosphamide

    is a chemotherapy medicine that suppresses the immune system and destroys cancer cells. It is often used in combination with other medicines for the treatment of breast cancer. It works by stopping the growth of cancer cells and is usually given through an infusion or as a tablet.

  • Paclitaxel

    is a chemotherapy medicine made from the bark of the yew tree. It is used to treat various types of cancer, including breast cancer. The medicine works by preventing cancer cells from dividing by disrupting their internal structure. It is given through an infusion into a vein.

  • Trastuzumab

    is a targeted therapy that works specifically against cancer cells that make too much of a certain protein, called HER2. It is an artificially produced antibody that attaches to this protein on the cancer cells and slows their growth. This medicine is used in patients with HER2-positive breast cancer and is given through an infusion.

  • Pertuzumab

    is a targeted therapy that works in combination with trastuzumab in HER2-positive breast cancer. It is also an artificial antibody, which attaches to a different part of the HER2 protein than trastuzumab, making the treatment more effective. It is given through an infusion.

What is already known about the treatment

  • Palbociclib

    Palbociclib is an anticancer medicine taken by mouth as a hard capsule, usually once a day for three weeks followed by a one-week break. It is approved worldwide and widely used in the treatment of certain forms of metastatic breast cancer that are sensitive to hormones. The medicine belongs to the group of CDK4/6 inhibitors: it blocks two proteins (cyclin-dependent kinases 4 and 6) that prompt cancer cells to divide, thereby slowing the growth of the tumor. Palbociclib is usually combined with hormone therapy to strengthen its effect.

  • Olaparib

    Olaparib is a film-coated tablet taken by mouth, usually twice a day. It is an approved and well-studied anticancer medicine used mainly for breast cancer, ovarian cancer, prostate cancer and pancreatic cancer with a fault in the BRCA genes. Olaparib belongs to the PARP inhibitors: it blocks the protein PARP, which cancer cells need to repair damage to their genetic material, so that these cells accumulate damage and die. Healthy cells can usually still repair that damage, which allows the medicine to act in a targeted way against the tumor.

  • Pertuzumab

    Pertuzumab is a medicine given as an infusion directly into a vein, usually once every three weeks. It is an established treatment for HER2-positive breast cancer, a form of breast cancer in which the tumor cells have large amounts of the HER2 protein on their surface. Pertuzumab is a monoclonal antibody that attaches to this HER2 protein and prevents it from working together with related proteins, thereby blocking the growth signals in the cancer cell. In addition, the medicine helps the immune system clear away the cancer cells, and it is often combined with trastuzumab and chemotherapy.

Investigated diseases

Breast cancer – Breast cancer is a disease where cells in the breast grow uncontrollably. It typically begins in the ducts or lobules of the breast. As the disease progresses, it can spread to nearby lymph nodes and other parts of the body. The growth of cancer cells can form a lump or mass in the breast, which may be detected through physical examination or imaging. Over time, the cancer may invade surrounding tissues and organs. Changes in the size, shape, or appearance of the breast or nipple may occur as the disease advances.
Trial detailsLast updated 4 Nov 2026
Age18+ yearsPhasePhase IITrial ID2024-519364-40-00Protocol codePETREMACEstimated enrolment200 patientsSponsorHelse Bergen HF

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