Not recruiting

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

Fast replyRegistered 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 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.

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.
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.
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.
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.
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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Verified sites

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

Akershus University Hospital
Verified
Lorenskog, Norway
Helse Bergen HF
Verified
Bergen, Norway
Universitetssykehuset Nord-Norge HF
Responsive
Tromsø, Norway

Trial locations

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Investigated drugs

Medication A
is a treatment used in the trial to help fight high-risk breast cancer. It works by targeting specific cancer cells and stopping them from growing and spreading. This medication is designed to be more effective for patients whose cancer has certain characteristics, making it a personalized treatment option.
Medication B
is another therapy being tested in the trial. It aims to boost the body's immune system to better recognize and attack cancer cells. By enhancing the immune response, this medication helps the body fight the cancer more effectively.
Medication C
is included in the trial to block certain signals that cancer cells use to grow. By interfering with these signals, the medication can slow down or stop the growth of the cancer, providing another way to treat high-risk breast cancer.
Medication D
is a supportive therapy used in the trial to help manage side effects and improve the overall well-being of patients undergoing cancer treatment. It is not directly targeting the cancer but helps patients tolerate the main treatments better.

What is already known about the treatment

Medication Name – This medication is administered orally in the form of a tablet. It is currently being studied in clinical trials for its effectiveness in treating breast cancer, as part of the PETREMAC trial. The main therapeutic indication is for high-risk breast cancer patients. At the molecular level, the medication works by targeting specific proteins in cancer cells, which helps to stop their growth and spread. It is classified pharmacologically as a targeted therapy, designed to interfere with cancer cell growth.

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.