Ongoing Clinical Trials for Breast Cancer Stage III
There are currently 5 ongoing clinical trials investigating new treatment approaches for stage III breast cancer. These studies are testing various combinations of immunotherapy drugs, targeted therapies, and chemotherapy agents across several European countries including the Netherlands, Italy, Germany, Spain, Austria, France, Ireland, Belgium, and Sweden.
Clinical trial locations
- Austria
- Belgium
- France
- Germany
- Ireland
- Italy
- Netherlands
- Spain
- Sweden
Study on Pre-Operative Treatment for Breast Cancer Using Nivolumab, Ipilimumab, and Relatlimab for Patients with Breast Cancer
This trial, conducted in the Netherlands, focuses on using immunotherapy drugs before surgery to treat certain types of stage I-III breast cancer. The study tests three medications—nivolumab, ipilimumab, and relatlimab—which are all given through an infusion directly into the bloodstream.
Inclusion criteria: Participants must be women aged 18 or older with breast cancer that can be surgically removed. The trial accepts two specific types: triple negative breast cancer (TNBC), which lacks estrogen, progesterone, and HER2 receptors, or Luminal B breast cancer with specific hormone receptor levels. Tumors must be larger than 5 mm as shown on MRI, and lymph node status must be verified through ultrasound or PET-CT scans. Participants should be fully active or able to carry out light work.
Exclusion criteria: Patients without a breast cancer diagnosis, males, and individuals outside the 18-65 age range cannot participate.
Focus and goal: The trial aims to determine whether these immunotherapy medications, used alone or in combination, can achieve a complete response before surgery. A complete response means no cancer cells remain in the breast or lymph nodes when examined microscopically. Researchers will monitor how the cancer responds using MRI scans and track long-term outcomes including survival rates and event-free survival.
Investigational drugs: Nivolumab, ipilimumab, and relatlimab are all immune checkpoint inhibitors that work by helping the immune system recognize and attack cancer cells more effectively. Each targets different proteins that normally keep the immune system in check, potentially enhancing the body’s natural ability to fight cancer.
Study on Restoring Immunotherapy Sensitivity in Advanced Triple Negative Breast Cancer Using Ceralasertib, Durvalumab, and Paclitaxel Albumin-Bound
This Italian study explores treatment options for advanced triple-negative breast cancer that has returned after previous immunotherapy and chemotherapy. Triple-negative breast cancer is a more aggressive form that lacks the three common receptors found in other breast cancers.
Inclusion criteria: Participants must have advanced triple-negative breast cancer that has progressed after previous treatment with immune checkpoint inhibitors and chemotherapy. They should be 18 or older with good organ function and able to swallow and retain oral medication. Women of childbearing age must have a negative pregnancy test and agree to use birth control. The cancer must show worsening through biopsy or imaging, and tumor tissue samples must be available. Participants should be fully active or have some symptoms but still capable of light work.
Exclusion criteria: Those who have not received prior immunotherapy and chemotherapy, patients with medical conditions other than advanced triple-negative cancer, individuals outside the eligible age range, and vulnerable populations cannot join.
Focus and goal: The study tests whether ceralasertib (taken as tablets) can prepare cancer cells to better respond to subsequent treatment with durvalumab (immunotherapy) and nab-paclitaxel (chemotherapy), both given through infusion. The goal is to restore sensitivity to immunotherapy in cancer that has become resistant. Researchers will measure progression-free survival and overall response to treatment.
Investigational drugs: Ceralasertib is an ATR kinase inhibitor that affects DNA damage repair in cancer cells. Durvalumab is an immune checkpoint inhibitor that helps the immune system attack cancer. Nab-paclitaxel is a chemotherapy drug that stops cancer cells from dividing.
Study of Sacituzumab Govitecan compared to standard therapy in HER2-negative breast cancer patients with high risk of relapse after neoadjuvant treatment
This multi-country trial (Germany, Spain, Austria, France, Ireland, and Belgium) compares a newer treatment called sacituzumab govitecan with standard therapies for HER2-negative breast cancer patients who remain at high risk after completing initial treatment.
Inclusion criteria: Participants must be at least 18 years old with confirmed HER2-negative breast cancer that still shows residual disease after receiving at least 16 weeks of chemotherapy containing taxane drugs. They must have undergone surgery and completed radiation therapy. The study must begin within 16 weeks after final surgery or 10 weeks after radiation, whichever comes last. Participants need good physical function, normal heart function, and acceptable blood test results. Women who can become pregnant must use effective birth control and have a negative pregnancy test.
Exclusion criteria: Those with HER2-positive cancer, individuals under 18, pregnant or breastfeeding women, people with active brain metastases, severe heart conditions, ongoing serious infections, uncontrolled autoimmune diseases, or history of other cancers within the past 3 years cannot participate. Those with known allergies to study medications or participating in other trials within the last 30 days are also excluded.
Focus and goal: The trial evaluates whether sacituzumab govitecan is more effective than standard treatments at preventing cancer return. Patients receive either sacituzumab govitecan or a doctor-selected standard treatment (carboplatin, cisplatin, or capecitabine) for up to 24 months. Researchers will track how long patients remain disease-free and monitor quality of life.
Investigational drugs: Sacituzumab govitecan is an antibody-drug conjugate that combines an antibody targeting the Trop-2 protein on cancer cells with a chemotherapy drug. This allows targeted delivery of chemotherapy directly to cancer cells while minimizing damage to healthy tissue.
Study of Trastuzumab, Pertuzumab, and Chemotherapy Combination with Response-Guided Treatment for Patients with HER2-Positive Breast Cancer
This Dutch study investigates whether reducing chemotherapy based on imaging results can be effective when combined with two targeted medications for HER2-positive breast cancer, which is characterized by high levels of the HER2 protein on cancer cell surfaces.
Inclusion criteria: Participants must be at least 18 years old with stage II or III HER2-positive breast cancer confirmed by ultrasound. The tumor must be visible on MRI and have known hormone receptor status. Participants need adequate blood test results showing healthy bone marrow, liver, and kidney function, plus good heart function with ejection fraction of 50% or higher. They should be fully active or have minimal limitations. Women who can become pregnant must agree to use birth control during treatment and for 7 months after, with a negative pregnancy test required.
Exclusion criteria: Those with metastatic cancer, previous chemotherapy or targeted therapy for breast cancer, severe allergies to study medications, significant heart problems, pregnancy or breastfeeding, active infections, other recent cancers, serious medical or mental health conditions, recent participation in other trials, or significant liver or kidney problems cannot join.
Focus and goal: The study evaluates whether chemotherapy can be safely reduced based on how well the cancer responds to treatment, as monitored through imaging. Participants receive Herceptin (trastuzumab) and Perjeta (pertuzumab) targeting HER2, along with paclitaxel and carboplatin chemotherapy. Some may also receive Kadcyla (trastuzumab emtansine). Treatment may be adjusted based on response after 3, 6, or 9 cycles. Patients will be followed for at least three years.
Investigational drugs: Herceptin and pertuzumab are both targeted therapies that work together as “dual HER2-blockade,” attaching to different parts of the HER2 protein to more effectively stop cancer cell growth signals.
Study on Preoperative Treatment for HER2 Positive Breast Cancer Using Docetaxel, Pertuzumab, and Trastuzumab in Patients with Primary Breast Cancer
This Swedish trial examines a response-guided treatment approach for HER2-positive primary breast cancer using a combination of targeted therapies and chemotherapy before surgery.
Inclusion criteria: Participants must be 18 or older with primary breast cancer confirmed by tissue examination, including tests for hormone receptors, HER2, and proliferation markers. The cancer must be larger than 20mm or have confirmed spread to lymph nodes. Tumor and blood samples must be available for genetic testing. Participants need adequate bone marrow, kidney, liver, and heart function, with heart ejection fraction greater than 55%. They should be fully active or able to carry out light work. The trial may also accept patients with up to two well-defined distant metastases treatable with stereotactic radiotherapy.
Exclusion criteria: Those with cancer types other than primary breast cancer or individuals outside the specified age range cannot participate.
Focus and goal: The study evaluates treatment with docetaxel, pertuzumab, and trastuzumab given through infusions or injections before surgery. Treatment may be adjusted based on how the cancer responds, potentially introducing trastuzumab emtansine. Researchers will assess clinical and radiological response, tumor characteristics, survival rates, and frequency of breast-conserving surgeries. Regular monitoring includes blood tests, imaging, and heart function assessments to ensure safety and effectiveness.
Investigational drugs: Trastuzumab targets the HER2 protein to stop cancer cell growth. Pertuzumab blocks HER2 proteins in a different way, enhancing treatment when combined with trastuzumab. Docetaxel is chemotherapy that interferes with cancer cell division. The trial also uses paclitaxel (another chemotherapy stopping cell division) and carboplatin (chemotherapy damaging cancer cell DNA).
Summary
These five clinical trials reflect the diverse treatment approaches being investigated for stage III breast cancer across Europe. A notable pattern is the focus on immunotherapy combinations, particularly immune checkpoint inhibitors like nivolumab, ipilimumab, durvalumab, and relatlimab, which harness the body’s immune system to fight cancer.
Three trials specifically target HER2-positive breast cancer using dual HER2-blockade with trastuzumab and pertuzumab, highlighting the importance of targeted therapy for this subtype. Two trials focus on triple-negative breast cancer, an aggressive form requiring innovative treatment approaches.
Several studies explore response-guided treatment strategies, where therapy adjustments are made based on how well the cancer responds to initial treatment. This personalized approach aims to optimize outcomes while potentially reducing unnecessary treatment intensity.
Geographically, the trials are distributed across multiple European countries, with the Netherlands hosting two studies and Germany, Spain, Austria, France, Ireland, Belgium, Italy, and Sweden each hosting one. The multi-country sacituzumab govitecan trial spans six nations, offering broader access to this investigational antibody-drug conjugate therapy.
These trials collectively represent ongoing efforts to improve treatment outcomes, reduce side effects, and personalize care for patients with stage III breast cancer through innovative drug combinations and treatment strategies.
