Study on the Safety and Effectiveness of Olaparib, Ceralasertib, and AZD1775 for Patients with Metastatic Triple Negative Breast Cancer

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What is this study about?

This clinical trial is focused on studying a type of breast cancer known as Triple Negative Breast Cancer, which is a form of cancer that does not have any of the three common receptors known to fuel most breast cancer growth. The study is investigating the effectiveness and safety of a treatment using a combination of medications. The medications being studied include Olaparib, which is already used in cancer treatment, and Ceralasertib, also known by its code name AZD6738. These medications are being tested both in combination and separately to see how well they work in treating this type of cancer.

The purpose of the study is to assess how these treatments can help patients with metastatic triple negative breast cancer, which means the cancer has spread to other parts of the body. The study will compare the effects of using Olaparib alone versus using it in combination with Ceralasertib. Participants will take these medications in the form of film-coated tablets, which are taken orally. The study will monitor the progression of the disease and any side effects that may occur during the treatment period.

Participants in the study will be randomly assigned to receive either the combination of medications or Olaparib alone. The study will take place over a period of time, with regular assessments to track the cancer’s response to the treatment. The goal is to determine which treatment option is more effective in managing the disease and improving the quality of life for patients with this challenging form of breast cancer.

1 joining the study

Upon joining the study, informed consent is required. This means understanding the study details and agreeing to participate.

Eligibility is confirmed based on specific criteria, such as age, cancer progression, and previous treatments.

2 randomization

Participants are randomly assigned to different treatment groups. This ensures that the study results are unbiased.

3 treatment phase

Participants receive either olaparib alone or in combination with ceralasertib.

Olaparib is administered as film-coated tablets, available in 100 mg and 150 mg doses, taken orally.

Ceralasertib is also administered as film-coated tablets, taken orally.

The dosage and frequency of administration are determined by the study protocol and may vary between participants.

4 monitoring and assessments

Regular monitoring is conducted to assess the treatment’s effectiveness and any side effects.

This includes imaging tests like CT or MRI scans to measure tumor size and progression.

Blood tests are performed to check organ function and drug levels in the plasma.

5 end of treatment

The treatment phase continues until the study’s end date or until the participant’s condition changes.

Participants may continue to be monitored for overall survival and any long-term effects.

Who Can Join the Study?

Provide informed consent before any study-specific procedures. This means you agree to participate after understanding the study details.
Be postmenopausal or have proof of not being able to have children if you are a woman who could potentially have children. This includes following birth control rules for you and your partner.
Be willing to follow the study’s rules and requirements.
Have a life expectancy of at least 16 weeks.
Be a male or female who is 18 years of age or older.
Have cancer that is getting worse at the time you join the study.
Have a confirmed diagnosis of Triple Negative Breast Cancer (TNBC) that has spread to other parts of the body and is HER2 negative according to specific guidelines.
Have received at least one and no more than two previous treatments for cancer that has spread, including specific drugs like anthracyclines (e.g., doxorubicin, epirubicin) and/or taxanes (e.g., paclitaxel, docetaxel), unless you cannot take them.
Have a confirmed presence or absence of a specific HRR mutation in your tumor tissue, as determined by a specific test.
Have at least one measurable tumor that can be accurately checked at the start of the study using a CT scan or MRI if a CT scan is not suitable, and can be checked again during the study.
Have normal function of your organs and bone marrow, as measured within 28 days before being randomly assigned to a treatment group.
Have an ECOG Performance Status of 0-1 within 28 days of being randomly assigned. This is a scale that measures your ability to perform daily activities.

Who Cannot Join the Study?

Patients with medical conditions other than Triple Negative Breast Cancer cannot participate. This type of cancer does not have certain receptors that are commonly found in breast cancer.
Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of participants.
Patients who are not female or male cannot participate. The study includes both genders.
Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children or the elderly.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country	Status
Servei De Salut De Les Illes Balears	Palma	Spain
Dfovqyermwnk Caiajfr Osudbyxuo Pixjqsajvlav I Hlvyzqghvuf	Wroclaw	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	31.10.2017
Portugal	Not recruiting	31.10.2017
Spain	Not recruiting	31.10.2017

Trial locations

Investigated drugs:

Olaparib is a medication used in this trial to treat metastatic triple-negative breast cancer. It works by blocking a specific enzyme involved in repairing damaged DNA in cancer cells, which can help to stop the growth of cancer.

Ceralasertib is being tested in combination with olaparib. It is designed to enhance the effects of olaparib by further inhibiting the cancer cells’ ability to repair DNA damage, potentially leading to more effective treatment outcomes.

AZD1775 is another medication being studied in combination with olaparib. It aims to disrupt the cancer cells’ repair mechanisms, similar to ceralasertib, and is being evaluated for its potential to improve the effectiveness of olaparib in treating the cancer.

Investigated diseases:

Triple negative breast cancer

Triple Negative Breast Cancer – This is a type of breast cancer that does not have any of the three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. It is considered more aggressive and difficult to treat than other types of breast cancer. The cancer cells in triple negative breast cancer do not respond to hormonal therapy medicines or medicines that target HER2 protein receptors. It tends to grow and spread more quickly than other types of breast cancer. This type of cancer is more likely to affect younger women and those with a BRCA1 gene mutation. It is often diagnosed at a later stage, which can make it more challenging to manage.

Trial ID:

2024-514205-60-00

Protocol code:

D5336C00001

NCT ID:

NCT03330847

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of Olaparib, Ceralasertib, and AZD1775 for Patients with Metastatic Triple Negative Breast Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?