Clinical Trials for Recurrent Breast Cancer
This article provides information about 6 ongoing clinical trials for patients with recurrent breast cancer. These studies are testing new treatments and combinations of medications to help prevent cancer from returning or to treat cancer that has come back. The trials are being conducted across several European countries including Belgium, France, Spain, Italy, Hungary, Germany, Austria, and Ireland.
Clinical trial locations
- Austria
- Study of palbociclib with hormone therapy versus hormone therapy alone in patients with recurrent hormone receptor-positive/HER2-negative breast cancer after surgery
- Study of Sacituzumab Govitecan compared to standard therapy in HER2-negative breast cancer patients with high risk of relapse after neoadjuvant treatment
- Belgium
- Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors
- Study of Paclitaxel, Carboplatin, and Durvalumab with or without Oleclumab for Patients with Untreated Advanced Triple-Negative Breast Cancer
- Study of Sacituzumab Govitecan compared to standard therapy in HER2-negative breast cancer patients with high risk of relapse after neoadjuvant treatment
- France
- Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors
- Study of Paclitaxel, Carboplatin, and Durvalumab with or without Oleclumab for Patients with Untreated Advanced Triple-Negative Breast Cancer
- Study of palbociclib with hormone therapy versus hormone therapy alone in patients with recurrent hormone receptor-positive/HER2-negative breast cancer after surgery
- Study of Sacituzumab Govitecan compared to standard therapy in HER2-negative breast cancer patients with high risk of relapse after neoadjuvant treatment
- Germany
- Hungary
- Ireland
- Italy
- Study on Restoring Immunotherapy Sensitivity in Advanced Triple Negative Breast Cancer Using Ceralasertib, Durvalumab, and Paclitaxel Albumin-Bound
- Study of palbociclib with hormone therapy versus hormone therapy alone in patients with recurrent hormone receptor-positive/HER2-negative breast cancer after surgery
- Spain
- Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors
- Study of palbociclib with hormone therapy versus hormone therapy alone in patients with recurrent hormone receptor-positive/HER2-negative breast cancer after surgery
- Study of Sacituzumab Govitecan compared to standard therapy in HER2-negative breast cancer patients with high risk of relapse after neoadjuvant treatment
Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors
This trial is testing a new medication called DS-3939a for patients with advanced solid tumors, including those with recurrent or metastatic cancer. The medication is delivered directly into the bloodstream through an intravenous infusion.
Main inclusion criteria: To join this study, participants must sign an informed consent form and have their heart function checked to ensure it is working properly. They need to have measurable disease, meaning the tumor can be tracked using medical imaging. Participants should be able to carry out daily activities with minimal assistance. The study includes two parts: Part 1 is open to patients with advanced cancer in organs such as the bladder, lung, breast, ovary, bile duct, or pancreas. Part 2 requires participants to have cancer that has progressed during or after recent treatment and must provide a tumor sample for testing.
Main exclusion criteria: Patients cannot participate if they have metastatic or advanced solid tumors outside the study’s focus, are not within the specified age range, belong to a vulnerable population, or do not meet safety requirements for the study drug.
Focus and goal: The trial aims to evaluate the safety and tolerability of DS-3939a and measure how effective it is at treating advanced solid tumors. The first part focuses on understanding side effects, while the second part looks at the treatment’s effectiveness in shrinking or controlling tumors.
Investigational drug: DS-3939a is an experimental medication designed to target specific pathways that cancer cells use to grow and spread. It is currently being studied for its potential to treat advanced and metastatic solid tumors.
Study on Restoring Immunotherapy Sensitivity in Advanced Triple Negative Breast Cancer Using Ceralasertib, Durvalumab, and Paclitaxel Albumin-Bound
This trial focuses on patients with advanced triple-negative breast cancer whose disease has returned after previous treatments. It tests whether a combination of ceralasertib, durvalumab, and paclitaxel albumin-bound can help restore the body’s sensitivity to immunotherapy.
Main inclusion criteria: Participants must have advanced triple-negative breast cancer that has returned after treatment with immune checkpoint inhibitors and chemotherapy. They must not have received chemotherapy specifically for the cancer that has spread. Participants need to have acceptable organ function, a negative pregnancy test if applicable, and proof that their disease has progressed since the last treatment. They must be at least 18 years old, able to swallow and retain oral medication, and have a tumor sample available for testing. The cancer must be measurable and participants should have an ECOG performance status of 0-1.
Main exclusion criteria: Patients cannot participate if their cancer has not returned after initial treatment, if they have not received immune checkpoint inhibitors and chemotherapy, if they have medical conditions other than advanced triple-negative breast cancer, if they are not within the specified age range, or if they belong to a vulnerable population.
Focus and goal: The study aims to determine if this treatment combination can restore immunotherapy sensitivity and help control cancer progression. It measures progression-free survival, which is the time from treatment start until disease progression or death, as well as overall response and survival rates.
Investigational drugs: Ceralasertib is taken in tablet form to prime cancer cells. Durvalumab is an immunotherapy drug given through infusion that helps the immune system recognize and attack cancer cells. Nab-paclitaxel is a chemotherapy drug administered through infusion that stops cancer cell growth.
Study Comparing Oral Paclitaxel (DHP107) and IV Paclitaxel for Patients with Recurrent or Metastatic HER2 Negative Breast Cancer
This study compares two forms of paclitaxel treatment for patients with HER2-negative breast cancer that has either returned or spread to other parts of the body. One form is taken by mouth and the other is given through an IV.
Main inclusion criteria: Participants must be at least 19 years old and have a confirmed diagnosis of recurrent or metastatic HER2-negative breast cancer. The HER2-negative status must be confirmed through specific tests. Participants need to have a life expectancy of at least 12 weeks, an ECOG performance status of 0-1, and measurable or evaluable lesions. They must have adequate blood, kidney, and liver function. If cancer has spread to the brain, it must be stable for more than 4 weeks. Participants must voluntarily agree to join and sign a consent form.
Main exclusion criteria: Patients with other types of cancer that are not HER2-negative breast cancer, those not experiencing recurrent or metastatic disease, those not within the specified age range, or those who are part of a vulnerable population cannot participate.
Focus and goal: The trial aims to determine if oral paclitaxel works as well as IV paclitaxel in treating this type of cancer. It monitors progression-free survival, treatment response, overall survival, and quality of life to see if the oral form can be a suitable first-line treatment option.
Investigational drugs: Oral paclitaxel (DHP107) is taken by mouth and may be more convenient than IV administration. IV paclitaxel is the standard form given through an intravenous line. Both work by stopping cancer cells from growing and dividing.
Study of Paclitaxel, Carboplatin, and Durvalumab with or without Oleclumab for Patients with Untreated Advanced Triple-Negative Breast Cancer
This trial is for patients with triple-negative breast cancer that has either returned locally and cannot be surgically removed or has spread to other parts of the body. It tests a combination of medications to see how effective they are in treating this aggressive form of cancer.
Main inclusion criteria: Participants must be at least 18 years old and provide a tumor sample from a previous biopsy or surgery. At least 6 months must have passed since the last curative treatment and the first sign of recurrence. Participants need to have at least one measurable tumor, proper organ function including adequate white blood cells, platelets, hemoglobin, normal kidney function, normal liver function, and normal blood clotting ability. They must be able to perform daily activities with little or no help and have a life expectancy of at least 12 weeks. They must weigh more than 35 kg and the cancer must be confirmed as triple-negative. Participants must agree to provide tissue and blood samples and give written consent.
Main exclusion criteria: Patients who have already received treatment for their cancer, those with cancer that can be surgically removed, those with cancer that is not triple-negative, male patients, or those who are not part of a vulnerable population cannot participate.
Focus and goal: The study is divided into two phases: the first confirms the safety of the drug combination, and the second evaluates clinical benefits by comparing patients who receive the combination with and without oleclumab. It aims to assess tumor response, disease control, and quality of life.
Investigational drugs: Paclitaxel stops cancer cells from dividing and growing. Carboplatin damages cancer cell DNA to prevent their multiplication. Durvalumab helps the immune system recognize and attack cancer cells. Oleclumab is an experimental drug that may enhance the effects of other treatments by blocking a protein that helps cancer cells evade the immune system.
Study of palbociclib with hormone therapy versus hormone therapy alone in patients with recurrent hormone receptor-positive/HER2-negative breast cancer after surgery
This study focuses on patients with hormone receptor-positive, HER2-negative breast cancer who have experienced a return of cancer in the same area after previous treatment. It tests whether adding palbociclib to standard hormone therapy works better than hormone therapy alone.
Main inclusion criteria: Participants must be at least 18 years old and have cancer that has returned locally, confirmed through tissue examination. The returning cancer must be hormone receptor-positive and HER2-negative. Surgical removal of the returning cancer must be completed within 6 months before joining the study. If radiation therapy was given, it must be completed at least 2 weeks before joining. Participants need good overall physical function, normal blood, kidney, and liver function test results, and must be willing to provide tumor tissue samples. They must be planning to start or already taking hormone therapy and be able to provide written informed consent.
Main exclusion criteria: Patients who have had prior treatment with CDK4/6 inhibitors, those with distant metastases, those who are currently pregnant or breastfeeding, those with uncontrolled heart conditions, active or untreated brain metastases, severe liver problems, known allergic reactions to study medications, participation in another clinical trial within the last 30 days, major surgery within 4 weeks, active uncontrolled infections, other types of cancer within the last 5 years, inability to swallow oral medications, or psychiatric conditions that could interfere with study participation cannot join.
Focus and goal: The trial aims to determine if using palbociclib together with hormone therapy for 3 years can help prevent cancer from returning compared to using only hormone therapy. It monitors for signs of recurrence, side effects, and overall health status.
Investigational drugs: Palbociclib belongs to a group of drugs called CDK4/6 inhibitors, which work by blocking certain proteins that help cancer cells grow. It is taken in tablet or capsule form. Hormone therapy blocks or lowers the amount of hormones in the body to stop or slow down the growth of hormone-sensitive cancer cells.
Study of Sacituzumab Govitecan compared to standard therapy in HER2-negative breast cancer patients with high risk of relapse after neoadjuvant treatment
This study focuses on patients with HER2-negative breast cancer who still have residual disease after receiving standard neoadjuvant chemotherapy and are at high risk of cancer returning. It compares sacituzumab govitecan with standard treatment options.
Main inclusion criteria: Participants must be at least 18 years old and agree to use effective birth control methods during treatment. They must have HER2-negative breast cancer confirmed by tissue examination with remaining cancer tissue after initial chemotherapy and specific risk factors for cancer return. They must have undergone proper surgical removal of cancer and lymph nodes, completed at least 16 weeks of chemotherapy containing taxane, and have no evidence of cancer spread. Participants must start the study within 16 weeks after final surgery or within 10 weeks after completing radiation therapy. They need good physical function, normal heart function, acceptable blood test results, a negative pregnancy test if applicable, and must have recovered from side effects of previous treatments.
Main exclusion criteria: Patients with previous HER2-positive breast cancer, those below 18 years old, pregnant or breastfeeding women, those with active or untreated brain metastases, severe heart conditions, ongoing serious infections, previous treatment with sacituzumab govitecan, known allergies to study medications, participation in another clinical trial within the last 30 days, significant liver or kidney dysfunction, uncontrolled high blood pressure, active autoimmune disease, history of other cancers within the past 3 years, or any condition that would make participation unsafe cannot join.
Focus and goal: The study aims to determine if sacituzumab govitecan is more effective at preventing cancer from returning compared to standard treatments. It monitors for disease return, side effects, and overall health status throughout the treatment period, which continues for up to 24 months.
Investigational drugs: Sacituzumab govitecan is a specialized medication that combines an antibody with an anti-cancer drug, designed to target specific cancer cells. The antibody part finds cancer cells while the drug part destroys them. Standard treatment options include carboplatin, cisplatin, or capecitabine, which are given either through intravenous infusion or as tablets depending on the chosen treatment.
Summary
These six clinical trials represent important research efforts for patients with recurrent breast cancer across Europe. The trials are concentrated primarily in Western European countries, with France participating in four trials, followed by Spain, Belgium, and Austria with three trials each. Italy, Hungary, Germany, and Ireland each host one or two trials.
The studies focus on different subtypes of recurrent breast cancer, particularly HER2-negative and triple-negative forms, which are often more challenging to treat. Several trials are testing immunotherapy combinations, including durvalumab and oleclumab, reflecting the growing importance of immune-based treatments. Other studies focus on targeted therapies such as palbociclib and sacituzumab govitecan, as well as comparing different forms of chemotherapy administration.
Most trials require participants to have completed previous treatments and meet specific criteria regarding organ function and overall health status. The studies vary in their approach, with some comparing new medications to standard treatments while others test combinations of multiple drugs. Treatment durations range from several months to three years, with careful monitoring throughout to assess both effectiveness and safety.
