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Study on the Effectiveness of Carboplatin and Olaparib for Patients with Triple-Negative Breast Cancer with Positive HRD Status

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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 a specific type of breast cancer known as triple-negative breast cancer that shows a characteristic called homologous recombination deficiency (HRD). The study aims to determine if a treatment combining the medication olaparib with the chemotherapy drug carboplatin is more effective than the standard chemotherapy treatment, which includes drugs like docetaxel, epirubicin, cyclophosphamide, doxorubicin, and carboplatin alone. Olaparib is also known by its code name AZD-2281.

The purpose of the study is to compare the effectiveness of these treatments in patients with early-stage triple-negative breast cancer that has tested positive for HRD. Participants will receive one of the treatment options before undergoing surgery. The study will involve several cycles of treatment, and the response of the cancer to these treatments will be assessed at the time of surgery. The study will also monitor the occurrence of any side effects and assess the quality of life and sexual health of the participants during the treatment period.

The study is designed to provide valuable information on the best treatment approach for this type of breast cancer, potentially improving outcomes for patients with this condition. The trial will run for a specified period, during which participants will be closely monitored to ensure their safety and to gather data on the effectiveness of the treatments being tested.

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
Initial treatment phase
The trial begins with the administration of chemotherapy. This phase involves receiving a combination of medications, including docetaxel, epirubicin, and cyclophosphamide. These medications are given through a vein (intravenous use).
The treatment is divided into cycles, with each cycle lasting a few weeks. The exact number of cycles and the schedule will be provided by the healthcare team.
Step 2
Alternative treatment phase
An alternative treatment option involves the use of carboplatin and olaparib. Carboplatin is administered intravenously, while olaparib is taken orally in the form of film-coated tablets.
This phase also consists of several cycles, with specific instructions on dosage and frequency provided by the healthcare team.
Step 3
Surgery
After completing the chemotherapy cycles, surgery is performed to remove the tumor. The type of surgery will depend on individual medical assessments and recommendations.
Step 4
Post-surgery treatment
Following surgery, additional treatment may be necessary. This could include further chemotherapy or radiation therapy, depending on the surgical outcomes and medical advice.
Step 5
Follow-up and monitoring
Regular follow-up appointments are scheduled to monitor recovery and assess the effectiveness of the treatment. These appointments may include physical exams, imaging tests, and laboratory tests.

Who can join the trial?

16 criteria

Must have signed an informed consent form before any study-related assessments and procedures.
Must be at least 18 years old.
Both pre-menopausal and postmenopausal women, as well as men, with early-stage triple-negative breast cancer can participate.
Must have a positive **HRD status**. This means the cancer cells have a specific genetic feature that can be identified through a test.
Must not have any distant metastasis, meaning the cancer has not spread to other parts of the body.
Must have cancer in only one breast.
Must be willing to undergo procedures to check lymph nodes, which are small glands that are part of the immune system.
Must have normal organ and bone marrow function, which will be checked through blood tests.
Must have an **ECOG performance status** of 0-1, which is a scale used to assess how well a person can perform daily activities.
Women who can have children must have a negative pregnancy test within 28 days before starting the study.
Women and men must use effective birth control during the study and for a period after the last dose of treatment.
Must be willing and able to follow the study protocol, including attending scheduled visits and undergoing examinations.
For the substudy, must have completed at least 4 cycles of specific chemotherapy treatments in the main study.
Must have completed local treatments like surgery or radiotherapy and recovered from any major surgery effects.
For the substudy, treatment with a specific drug should ideally start within 8 weeks after the last treatment, but no later than 12 weeks.
For the substudy, must have adequate organ and bone marrow function without recent blood transfusions.

Who cannot join the trial?

4 criteria

Patients who do not have early invasive triple negative breast cancer with positive **HRD** status. **HRD** stands for **homologous recombination deficiency**, which is a specific condition of the cancer cells.
Patients who are not within the specified age range for the study.
Patients who do not meet the gender requirements for the study.
Patients who are part of a vulnerable population that the study is not designed to include.

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Verified sites

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

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Medical University Of Graz
Graz, Austria
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Medical University Of Vienna
Vienna, Austria
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Medizinische Universitaet Innsbruck
Innsbruck, Austria

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Investigated drugs

Carboplatin
is a chemotherapy medication used to treat various types of cancer. In this trial, it is used before surgery to help shrink tumors in patients with triple-negative breast cancer. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing.
Olaparib
is a medication that targets cancer cells with specific genetic features, such as those with homologous recombination deficiency (HRD). It is used in this trial to treat patients with triple-negative breast cancer before surgery. Olaparib works by blocking an enzyme that cancer cells need to repair their DNA, leading to cell death.
Taxane-based Chemotherapy
is a type of cancer treatment that includes medications like paclitaxel or docetaxel. These drugs are used to stop cancer cells from dividing and growing. In this trial, taxane-based chemotherapy is given before surgery to help reduce the size of the breast cancer tumors.
Anthracycline-based Chemotherapy
includes drugs such as doxorubicin or epirubicin, which are used to treat various cancers. These medications work by interfering with the DNA inside cancer cells, preventing them from multiplying. In this study, anthracycline-based chemotherapy is part of the treatment given before surgery to help manage breast cancer.

What is already known about the treatment

Carboplatin
This medication is administered intravenously and is currently used in clinical trials for treating early invasive triple-negative breast cancer with positive homologous recombination deficiency (HRD) status. It is primarily indicated for use in pre-operative treatment to improve surgical outcomes. Carboplatin works by interfering with the DNA of cancer cells, preventing them from dividing and growing. It belongs to the pharmacological class of platinum-based chemotherapy drugs.
Olaparib
This medication is taken orally and is being studied in clinical trials for its effectiveness in treating early invasive triple-negative breast cancer with positive HRD status. It is used as a pre-operative treatment to enhance the effectiveness of surgery. Olaparib functions by inhibiting the enzyme PARP, which helps repair DNA damage in cells, thereby making cancer cells more susceptible to treatment. It is classified as a PARP inhibitor in pharmacology.

Investigated diseases

Early Invasive Triple Negative Breast Cancer with Positive HRD Status – This is a type of breast cancer that lacks three common receptors known to fuel most breast cancer growths: estrogen, progesterone, and the HER-2/neu gene. It is characterized by its aggressive nature and tendency to spread quickly. The term "early invasive" indicates that the cancer has begun to invade surrounding breast tissue but is still in the early stages. The positive HRD (homologous recombination deficiency) status suggests a defect in the cancer cells' ability to repair DNA, making them potentially more responsive to certain treatments. This condition is identified using specific tests, such as the Myriad myChoice© test, which assesses the HRD status. Understanding the HRD status is crucial for determining the most effective treatment approach.