Ongoing Clinical Trials for Breast Cancer Stage IV
There are currently 4 ongoing clinical trials investigating new treatments for breast cancer that has spread to other parts of the body. These studies are testing various combinations of immunotherapy, chemotherapy, and targeted therapies across several European countries including Belgium, France, Italy, and Spain.
Clinical trial locations
- Belgium
- France
- Italy
- Spain
Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors
This trial is testing a new medication called DS-3939a, delivered directly into the bloodstream through an intravenous infusion. The study is divided into two parts: the first focuses on understanding how safe the medication is and whether patients can tolerate it well, while the second part examines how effective it is at shrinking or controlling tumors.
Main inclusion criteria: Participants must be able to provide informed consent and have a heart that pumps blood effectively (at least 50% ejection fraction). They need to have measurable disease based on standard cancer measurement criteria and be able to carry out daily activities with minimal limitations. For the first part of the study, patients must have confirmed advanced cancer in specific organs including the bladder, lung, breast, ovary, bile duct, or pancreas. For the second part, patients must show disease progression during or after their most recent treatment and be able to provide either a fresh tumor sample or one taken within the previous 6 months.
Main exclusion criteria: Patients cannot participate if they fall outside the specified age range for the study or belong to vulnerable populations such as pregnant women or those unable to provide consent. Additionally, those who do not meet the safety and tolerability requirements for DS-3939a are excluded.
Focus and goal: The trial aims to evaluate both the safety and effectiveness of DS-3939a in treating advanced solid tumors that have spread beyond their original location. The study will measure how well patients respond to treatment by tracking whether their tumors shrink or remain stable. Researchers will also monitor participants closely through regular check-ups, laboratory tests, and imaging studies.
Investigational drug: DS-3939a is an experimental medication designed to target specific pathways that cancer cells use to grow and spread, though the exact mechanism is still under investigation.
Study of Pembrolizumab and Carboplatin for Patients with BRCA-Related Metastatic Breast Cancer
This study is investigating a combination treatment using Pembrolizumab, an immunotherapy drug, together with Carboplatin, a chemotherapy medication. Both are given through intravenous infusion. The trial is specifically for patients whose cancer is related to mutations in the BRCA1 or BRCA2 genes.
Main inclusion criteria: Participants must be at least 18 years old and have provided written consent. They must have cancer that has spread to other parts of the body and shown growth in medical imaging within the past 12 months. A documented harmful or possibly harmful change in the BRCA1 or BRCA2 genes is required. Patients must have at least one tumor that can be measured and have previously received specific chemotherapy treatments called anthracyclines and taxanes. They can have received no more than one type of chemotherapy for advanced disease. Participants must be able to perform daily activities with minimal limitation and have a life expectancy of more than 3 months.
Main exclusion criteria: Patients with cancer not related to BRCA mutations, those without a diagnosis of metastatic breast cancer, individuals outside the specified age range, and members of vulnerable populations cannot participate.
Focus and goal: The trial evaluates how effectively the combination of Pembrolizumab and Carboplatin works in patients with BRCA-related metastatic breast cancer. Throughout the study, doctors will use imaging tests to assess whether the cancer is shrinking or staying stable, measuring this through the objective response rate.
Investigational drugs: Pembrolizumab is an immunotherapy that helps the immune system recognize and attack cancer cells by blocking a protein that shields them. Carboplatin is a chemotherapy drug that damages the DNA of cancer cells, preventing them from dividing and growing.
Study on Restoring Immunotherapy Sensitivity in Advanced Triple Negative Breast Cancer Using Ceralasertib, Durvalumab, and Paclitaxel Albumin-Bound
This trial focuses on advanced triple-negative breast cancer, a type that lacks the three common receptors that fuel most breast cancer growth. The study tests a treatment plan that begins with ceralasertib tablets, followed by a combination of durvalumab and paclitaxel albumin-bound given through infusion.
Main inclusion criteria: Patients must have advanced triple-negative breast cancer that has returned after initial treatment that included immune checkpoint inhibitors and chemotherapy. They should not have received chemotherapy for cancer that has already spread. Participants must have acceptable organ function and, if female, a negative pregnancy test with agreement to use effective birth control. They must be at least 18 years old and able to swallow and retain oral medication. A sample of the original tumor tissue must be available, and the most recent tumor sample must show negative ER/PgR and HER2 status. The disease must be measurable, and patients must be able to carry out light work despite having some symptoms.
Main exclusion criteria: Patients who have not experienced cancer recurrence after initial treatment, those who did not receive immune checkpoint inhibitors and chemotherapy previously, individuals with medical conditions other than advanced triple-negative breast cancer, those outside the specified age range, and vulnerable populations are excluded.
Focus and goal: The study aims to determine whether this treatment plan can restore the body’s sensitivity to immunotherapy in patients whose cancer has returned. The trial will monitor disease progression and track participants’ overall health and survival while assessing any side effects.
Investigational drugs: Ceralasertib is being studied for its potential to make cancer cells more responsive to subsequent treatments by inhibiting a protein involved in DNA damage repair. Durvalumab is an immunotherapy drug that helps the immune system attack cancer cells by blocking a protective protein. Nab-paclitaxel is a chemotherapy drug that stops cancer cell growth by interfering with cell division.
Study of Eftilagimod Alpha and Paclitaxel in Patients with HER2-Negative/Low Metastatic Breast Cancer
This trial is testing eftilagimod alpha, an experimental treatment given as a subcutaneous injection (under the skin), in combination with the standard chemotherapy drug paclitaxel. The study includes a comparison group receiving paclitaxel with a placebo. The trial begins with a dose-finding phase and then moves to the main study where participants are randomly assigned to treatment groups.
Main inclusion criteria: Participants must provide written consent and have mild or resolved side effects from previous treatments, except for certain liver-related issues and hair loss. They must meet specific blood test requirements showing adequate numbers of blood cells and normal liver and kidney function. Patients need to have HER2-negative or low breast cancer confirmed by biopsy. If their cancer is hormone receptor positive, they should have tried at least one hormone therapy. For the initial study phase, participants must be female and at least 18 years old; for the main phase, both males and females aged 18 or older can participate. Those who can become pregnant must have a negative pregnancy test and use effective birth control. Participants must have a good general health status and an expected survival of more than three months.
Main exclusion criteria: Patients with a different type of cancer, those not fully recovered from previous treatments, individuals with serious heart problems or uncontrolled high blood pressure, those with active infections requiring treatment, pregnant or breastfeeding women, patients who have had another cancer recently (with certain exceptions), organ transplant recipients, those taking interfering medications, patients with severe allergic reaction history to similar treatments, those with substance abuse history, and individuals unable to follow study procedures are excluded.
Focus and goal: The primary objective is to determine whether combining eftilagimod alpha with paclitaxel improves overall survival compared to paclitaxel with a placebo. The trial will monitor participants regularly to assess treatment effects and safety, with expected completion in 2027.
Investigational drugs: Eftilagimod alpha is an experimental immunotherapy agent that works by modulating the immune system, specifically targeting the LAG-3 protein to enhance the body’s immune response against cancer cells. Paclitaxel is a standard chemotherapy drug that stops cancer cells from dividing and growing.
Summary
These four clinical trials represent diverse approaches to treating stage IV breast cancer across Europe. Italy hosts two trials focusing on specific genetic subtypes: BRCA-related cancer and triple-negative breast cancer. Belgium and Spain each host two trials, with Belgium participating in both the DS-3939a study and the eftilagimod alpha trial, while Spain is involved in these same two studies. France participates in the DS-3939a trial.
The trials reflect current trends in cancer treatment research, with three of the four studies incorporating immunotherapy approaches either alone or in combination with chemotherapy. Two trials specifically target patients with genetic mutations or specific cancer subtypes (BRCA-related and triple-negative breast cancer), demonstrating the growing emphasis on personalized medicine. The combination of established chemotherapy drugs like paclitaxel and carboplatin with newer immunotherapy agents is a common theme, suggesting researchers are exploring how to enhance the effectiveness of existing treatments.
Patients interested in participating should discuss these options with their healthcare providers to determine which trial, if any, might be appropriate for their specific situation. Eligibility requirements vary considerably between studies, particularly regarding previous treatments received and specific cancer characteristics.
