Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

ABCSG 45: A prospective, open, randomized, phase II study of carboplatin/olaparib in the pre-operative treatment of patients with triple-negative primary breast cancer which exhibit the features of positive homologous recombination deficiency (HRD) status

This research trial, called ABCSG 45, is testing a new way to treat early-stage breast cancer that has a specific genetic feature called 'HRD positive'. This type of cancer is also known as 'triple-negative breast cancer'. The study will compare two different treatments given before surgery. One group of patients will receive a combination of two drugs, Lynparza (olaparib) and carboplatin. The other group will receive a standard chemotherapy treatment that includes drugs like cyclophosphamide, doxorubicin/epirubicin, and docetaxel. The main goal is to see which treatment shrinks the cancer more and to understand any side effects. We also want to see how this treatment affects patients' quality of life.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Verein Zur Praevention Und Therapie Boesartiger Erkrankungen Austrian Breast And Colorectal Cancer Study Group

Enrolment target

Start

26 Apr 2024

Early invasive triple negative breast cancer with positive HRD status (acc. to Myriad mychoice© test)

What is this study about?

This clinical trial, known as ABCSG 45, is designed to investigate a treatment for a particular type of early breast cancer. The cancer being studied is called 'triple-negative breast cancer' and also has a specific genetic characteristic known as 'HRD positive'. This means the cancer cells have trouble repairing themselves, which can make them more sensitive to certain treatments.

Currently, many people with this type of cancer receive chemotherapy before surgery to try and shrink the tumour. This study is comparing a new treatment combination — Lynparza (olaparib) with carboplatin — against the standard chemotherapy treatment. Lynparza is a targeted drug that works by interfering with the cancer cells' ability to repair their DNA, which can be particularly effective in HRD-positive cancers. Carboplatin is a type of chemotherapy.

The main aim of the study is to see how much the cancer shrinks after each treatment before surgery. Researchers will look at tissue from the tumour after it's removed to assess this. They also want to understand any side effects the treatments might cause and how they affect a patient's overall quality of life during treatment. The hope is that the new combination might offer a more effective or better-tolerated treatment option for this specific type of breast cancer.

Key takeaways

Tests a new treatment (olaparib + carboplatin) for a specific type of early breast cancer.
Compares the new treatment with standard chemotherapy before surgery.
Focuses on 'triple-negative' breast cancer with 'HRD positive' genetic features.
Aims to see which treatment shrinks the cancer more and assess side effects and quality of life.
Findings could help improve future treatments for this cancer type.
You and your doctor will know which treatment you are receiving.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with early-stage breast cancer. Specifically, your cancer needs to be a type called 'triple-negative breast cancer' and also show signs of 'HRD positive' status. This HRD positive status is usually confirmed with a special test called the Myriad mychoice® test.

Both men and women can take part in this study, as long as they meet the specific cancer type and age requirements. Before you can join, the study team will carefully check all your medical information to make sure the trial is right for you and that you're healthy enough to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with early breast cancer?
Is your breast cancer a type called 'triple-negative'?
Has your cancer been tested and found to be 'HRD positive' (e.g. by Myriad mychoice® test)?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive one of the two treatment options before your breast cancer surgery. The treatments involve taking medications, either as tablets or through infusions (drips), over a period of time. You will have regular appointments at the hospital to receive your treatment, have blood tests, and undergo examinations to monitor your health and how well the treatment is working.

Before you start, and during the study, you'll be asked to fill out questionnaires about your quality of life and sexual health. After your surgery, the doctors will examine the removed tumour to see how much the cancer has shrunk. The total duration of the pre-operative treatment will involve several cycles of medication, and you'll have follow-up appointments after surgery to continue monitoring your recovery and health.

Potential risks and benefits

Potential benefits of joining this study include receiving a new, experimental treatment that might be more effective for your specific type of breast cancer than standard options, or it might have different or fewer side effects. You'll also be closely monitored by a dedicated medical team. However, there are potential risks, as all medical treatments can have side effects. The medications used, both new and standard, can cause various side effects, which will be carefully explained to you. There's no guarantee the experimental treatment will work better than the standard one. Crucially, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Austria

Common questions

What is 'triple-negative breast cancer'?

Triple-negative breast cancer is a type of breast cancer that doesn't have the three most common receptors found on cancer cells (oestrogen, progesterone, and HER2). This means it doesn't respond to treatments that target these receptors.

What does 'HRD positive' mean?

HRD positive means your cancer cells have difficulty repairing their DNA damage. This genetic feature can make them more sensitive to certain types of drugs, like olaparib and carboplatin, that target DNA repair pathways.

What is Lynparza (olaparib)?

Lynparza is a targeted drug that works by blocking a protein involved in repairing damaged DNA in cancer cells. For cancers that struggle with DNA repair (like HRD positive cancers), blocking this protein can lead to the cancer cells dying.

Will I know which treatment I am getting?

Yes, this is an 'open-label' study meaning both you and your doctors will know which treatment you are receiving (either olaparib/carboplatin or the standard chemotherapy).

Why take treatment before surgery?

Giving treatment before surgery (called 'pre-operative' or 'neoadjuvant' treatment) can help shrink the tumour, making surgery easier. It also allows doctors to see how well the cancer responds to the treatment.