Recruiting

Study on zAvatar Test for Treatment Decisions in Relapsed Ovarian Cancer and Metastatic Breast Cancer Using Palbociclib and Drug Combination for Eligible Patients

Verified siteRegistered 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 two types of cancer: breast cancer and ovarian cancer. The study aims to evaluate a new test called the zAvatar-test, which helps doctors decide the best treatment for patients with relapsed ovarian cancer and metastatic breast cancer. Metastatic breast cancer is a type of breast cancer that has spread to other parts of the body, and relapsed ovarian cancer is when the cancer returns after treatment. The study will compare the effectiveness of treatments chosen based on the zAvatar-test with those chosen by standard medical practice.

Participants in the study will receive one of several possible treatments, which include medications such as Palbociclib, Capecitabine, Niraparib, Doxorubicin Hydrochloride, Topotecan, Paclitaxel, Sacituzumab Govitecan, Fulvestrant, Carboplatin, Docetaxel, Vinorelbine, Olaparib, Bevacizumab, Cyclophosphamide, and Etoposide. Some patients may receive a placebo, which is a substance with no active medication. The study will last for a maximum of 24 months, during which the effectiveness of the treatments will be monitored.

The main goal of the study is to see if the zAvatar-test can better predict which treatments will work best for patients, helping to improve their progression-free survival, which means the length of time during and after treatment that a patient lives with the disease without it getting worse. The study will also look at other outcomes, such as the overall survival of patients and their response to the treatments. This research could lead to more personalized and effective treatment options for patients with these types of cancer.

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 study
Upon joining the study, the patient will be informed about the trial procedures and will provide consent to participate.
The patient will be assessed to ensure they meet the eligibility criteria, which includes having a confirmed diagnosis of relapsed ovarian cancer or metastatic breast cancer.
Step 2
Treatment assignment
The patient will be randomly assigned to one of two treatment groups: the zAvatar-test-based therapeutic decision group or the standard of care group.
The zAvatar test is used to predict the most effective treatment for the patient.
Step 3
Treatment administration
The patient will receive treatment based on their assigned group. This may include medications such as palbociclib, capecitabine, niraparib, and others, administered either orally or through intravenous infusion.
The specific medications, dosage, and frequency will be determined by the treatment plan.
Step 4
Monitoring and follow-up
The patient's response to treatment will be monitored regularly through medical assessments and tests.
Progression-free survival (PFS) will be evaluated to determine the effectiveness of the treatment.
Step 5
Completion of the study
Upon completion of the treatment period, the patient's overall response and survival will be assessed.
The study aims to compare the outcomes of the zAvatar-test-based treatment with the standard of care.

Who can join the trial?

13 criteria

For both ovarian and breast cancer, participants must be women aged 18 years or older who can understand the study procedures and sign a written consent form.
Participants with ovarian cancer must have a measurable disease, which means at least one tumor that can be measured according to specific criteria called RECIST 1.1.
Participants with breast cancer must have confirmed stage IV breast cancer, which is advanced cancer that has spread to other parts of the body. The cancer should be HER2-negative, which is a specific type of breast cancer, regardless of the status of another marker called Estrogen Receptor (ER).
Participants with breast cancer should have a high amount of fluid in the abdomen (ascites) or around the lungs (malignant pleural effusion) that needs to be drained.
Participants must have an ECOG performance status of 0-2, which is a scale used to assess how well a patient can perform daily activities. A score of 0-2 means the patient is able to carry out most activities.
Participants with ovarian cancer must have inoperable high-grade serous carcinoma or high-grade endometrioid relapsed ovarian cancer, with a high amount of fluid in the abdomen or around the lungs that needs to be drained.
Participants with ovarian cancer must have either platinum-sensitive disease, meaning the cancer returns 6 months or more after the last platinum-based treatment, or platinum-resistant disease, meaning the cancer returns less than 6 months after the last platinum-based treatment.
Participants must have a decision made for therapy treatment, meaning there is a plan to treat the cancer.
Participants with breast cancer must be in the second line or later lines of treatment, meaning they have already received at least one type of treatment before. They should be included in the study before starting a new treatment and have at least two treatment options to be tested.
Participants with ovarian cancer can be in the first line or later lines of treatment after the cancer returns. They should be included in the study before starting a new treatment and have at least two treatment options to be tested.
Participants must have adequate bone marrow and coagulation function, which means their blood cells and clotting ability are sufficient for treatment.
Participants must have adequate liver, kidney, and heart functions to safely undergo treatment.
Participants with breast cancer must have a measurable disease, meaning at least one tumor that can be measured according to specific criteria called RECIST 1.1.

Who cannot join the trial?

2 criteria

Patients who are not female cannot participate in the study.
Patients who are part of a vulnerable population, which means groups that might need special protection, are not eligible.

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Verified sites

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Unidade Local De Saude De Lisboa Ocidental E.P.E.
Responsive
Carnaxide, Portugal
Unidade Local De Saúde De Santa Maria, E.P.E.
Verified
Lisbon, Portugal

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Investigated drugs

zAvatar-test
This is a predictive model used to help make treatment decisions for patients with relapsed ovarian cancer and metastatic breast cancer. The test aims to determine the most effective treatment by analyzing the patient's specific cancer characteristics. The goal is to improve the patient's progression-free survival by tailoring the treatment to their individual needs.
Standard of Care
This refers to the usual treatment provided to patients with relapsed ovarian cancer and metastatic breast cancer. It involves using established medical guidelines and practices to manage the patient's condition. The standard of care serves as a comparison to evaluate the effectiveness of the zAvatar-test-based therapeutic decisions.

What is already known about the treatment

zAvatar – This medication is administered orally and is currently being evaluated in clinical trials for its effectiveness in treating relapsed ovarian cancer and metastatic breast cancer. It is not yet widely recognized in medical literature as a standard treatment. The main therapeutic indications include its use in patients with relapsed ovarian cancer and metastatic breast cancer, particularly those with malignant pleural effusion or ascites. The mechanism of action involves targeting specific cancer cell pathways to inhibit tumor growth and progression. It is classified pharmacologically as an antineoplastic agent.

Investigated diseases

Breast Cancer
This is a type of cancer that forms in the cells of the breasts. It often begins in the milk-producing ducts or the glandular tissue called lobules. The disease can spread to other parts of the body through the lymphatic system or bloodstream. Symptoms may include a lump in the breast, changes in breast shape, dimpling of the skin, or fluid coming from the nipple. The progression can vary, with some cases growing slowly and others spreading quickly. It is one of the most common cancers affecting women worldwide.
Ovarian Cancer
This cancer originates in the ovaries, which are part of the female reproductive system. It often goes undetected until it has spread within the pelvis and abdomen. Early-stage ovarian cancer rarely causes any symptoms, but advanced-stage cancer can cause symptoms such as abdominal bloating, weight loss, and pelvic discomfort. The disease can progress rapidly, making early detection challenging. It typically involves the epithelial cells on the surface of the ovary, but can also arise from other cell types within the ovary. Ovarian cancer is less common than breast cancer but is more difficult to diagnose early.