Ongoing Clinical Trials for Breast Cancer Stage I
There are currently 3 clinical trials investigating new treatment approaches for breast cancer stage I, focusing primarily on triple-negative breast cancer subtypes and HER2-negative disease. These trials are being conducted across several European countries including Germany, France, Spain, Austria, Ireland, and Belgium, testing innovative treatments such as sacituzumab govitecan and pembrolizumab, either alone or in combination with other therapies.
Clinical trial locations
- Austria
- Belgium
- France
- Germany
- Ireland
- Spain
Study Comparing Sacituzumab Govitecan Alone and with Pembrolizumab for Patients with Low-Risk, Triple-Negative Early Breast Cancer
This trial is investigating treatments for a specific type of breast cancer called triple-negative early breast cancer with a low risk of returning. Triple-negative breast cancer lacks three common receptors that fuel most breast cancer growth, which means it doesn’t respond to hormonal therapy or HER2-targeted treatments. The study compares two approaches: using sacituzumab govitecan alone or combining it with pembrolizumab.
Main inclusion criteria: Participants must have triple-negative early breast cancer that is ER and PR negative or low positive (10% or fewer positive cells) and HER2 negative. They must be at least 18 years old and have good overall health, as measured by performance status scores. Laboratory tests must show adequate blood cell counts, with white blood cells at least 3.5 x 10⁹/L, neutrophils more than 1.5 x 10⁹/L, and platelets at least 100 x 10⁹/L. Liver and kidney function must be within acceptable ranges. Women of childbearing potential must use effective contraception during the study and for 7 months afterward, and must have a negative pregnancy test before starting.
Main exclusion criteria: Patients with medical conditions other than low-risk triple-negative early breast cancer cannot participate. Those outside the specified age range or not meeting gender requirements are excluded. Vulnerable populations who might be at higher risk of harm or exploitation in the study are also excluded.
Study focus: The trial aims to determine whether the combination of sacituzumab govitecan and pembrolizumab is more effective than sacituzumab govitecan alone in preventing cancer from returning. Researchers will check for the absence of cancer in the breast and lymph nodes after treatment and will track participants’ health over three years to monitor for any recurrence. The study also evaluates quality of life at various points during and after treatment.
Investigational drugs: Sacituzumab govitecan is an antibody-drug conjugate that combines an antibody with a chemotherapy drug. The antibody helps the medication find and attach to cancer cells, while the chemotherapy component works to destroy them. Pembrolizumab is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells more effectively. Both medications are administered through intravenous infusion.
Study on Pembrolizumab and Paclitaxel for Early Triple-Negative Breast Cancer in Patients with High Tumor-Infiltrating Lymphocytes
This clinical trial focuses on early-stage triple-negative breast cancer in patients whose tumors have high levels of immune cells called tumor-infiltrating lymphocytes. The study tests whether combining pembrolizumab with paclitaxel after surgery can help prevent the cancer from returning.
Main inclusion criteria: Participants must be at least 18 years old with a confirmed diagnosis of pT1b/c N0M0 triple-negative breast cancer that has been completely removed through surgery. The cancer must be staged according to specific guidelines. Patients must have undergone either breast-conserving surgery or mastectomy, along with lymph node examination. There must be at least 4 weeks but no more than 12 weeks between final surgery and study enrollment. Women of childbearing potential must agree to use effective contraception for 3 years after joining, and men must use contraception during treatment and for at least 6 months after. A negative pregnancy test is required within 72 hours before treatment starts.
Main exclusion criteria: Patients without triple-negative breast cancer are excluded. Those outside the specified age ranges or who do not meet specific criteria regarding stromal tumor-infiltrating lymphocytes cannot participate. The study is focused on female patients only. Vulnerable populations requiring special protection in research settings may not be eligible.
Study focus: The trial investigates whether the combination of pembrolizumab and paclitaxel is more effective than standard surveillance alone in preventing cancer recurrence. Participants are divided into two groups: one receives the combination treatment every 3 weeks, while the other undergoes regular monitoring without additional treatment. The study tracks participants over several years, focusing on whether the cancer returns, if new cancers develop, and overall survival rates. Quality of life is also assessed using standardized questionnaires.
Investigational drugs: Pembrolizumab is an immunotherapy medication that works by blocking a specific protein on cancer cells, allowing the immune system to better recognize and attack them. It belongs to a class of drugs called immune checkpoint inhibitors. Paclitaxel is a chemotherapy drug that stops cancer cells from dividing and growing, which can help shrink tumors and slow cancer spread. Both medications are administered through intravenous infusion in a clinical setting.
Study of Sacituzumab Govitecan compared to standard therapy in HER2-negative breast cancer patients with high risk of relapse after neoadjuvant treatment
This study is designed for patients with HER2-negative breast cancer who still have residual disease after receiving chemotherapy before surgery and are at high risk of the cancer returning. HER2-negative means the cancer cells don’t have high levels of a protein called human epidermal growth factor receptor 2.
Main inclusion criteria: Participants must be at least 18 years old and have HER2-negative breast cancer confirmed by tissue examination. They must have remaining cancer tissue after initial chemotherapy treatment with specific risk factors for cancer return. Patients must have undergone proper surgical removal of the cancer and lymph nodes and completed at least 16 weeks of chemotherapy containing taxane. The study must begin within 16 weeks after final surgery or within 10 weeks after completing radiation therapy. Participants must have good physical function, normal heart function, and acceptable blood test results showing adequate blood cell counts, liver function, and kidney function. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.
Main exclusion criteria: Patients with previous HER2-positive breast cancer diagnosis are excluded. Pregnant or breastfeeding women cannot participate. Those with active or untreated brain metastases, severe heart conditions, ongoing serious infections, or significant liver or kidney dysfunction are excluded. Patients who have previously received sacituzumab govitecan, have known allergies to study medications, or participated in another clinical trial within 30 days are not eligible. History of other cancers within the past 3 years (except successfully treated non-melanoma skin cancer or cervical cancer) is also an exclusion criterion.
Study focus: The trial compares sacituzumab govitecan with standard treatment options chosen by the doctor, which may include carboplatin, cisplatin, or capecitabine. The primary goal is to determine if sacituzumab govitecan is more effective at preventing cancer recurrence compared to these standard treatments. Treatment continues for up to 24 months, with regular assessments to check for side effects and monitor quality of life. Participants will be followed until 2027 to track how long they remain free of invasive disease.
Investigational drugs: Sacituzumab govitecan is an antibody-drug conjugate that combines a monoclonal antibody targeting the Trop-2 protein with a potent chemotherapy drug. This allows the medication to specifically target cancer cells expressing Trop-2 and deliver the chemotherapy directly to them, minimizing damage to healthy tissue. It is administered intravenously. The standard treatment options include carboplatin and cisplatin (both given through intravenous infusion) or capecitabine (taken as tablets by mouth), with the choice depending on the patient’s specific situation and medical history.
Summary
These three clinical trials demonstrate a strong focus on triple-negative and HER2-negative breast cancer subtypes in stage I disease. A notable pattern is the emphasis on sacituzumab govitecan, which appears in two of the three trials, highlighting growing interest in this antibody-drug conjugate as a potential treatment option. Pembrolizumab, an immunotherapy agent, also features prominently in two studies, either combined with sacituzumab govitecan or with the chemotherapy drug paclitaxel.
The trials are being conducted across multiple European countries, with Germany, France, and Spain hosting multiple studies. This geographic distribution provides broader access to these experimental treatments for European patients. Each trial targets different risk levels within early breast cancer: one focuses on low-risk triple-negative disease, another on high tumor-infiltrating lymphocytes, and the third on high-risk patients with residual disease after initial treatment.
All three studies share similar eligibility requirements regarding age (18 years and older), adequate organ function, and the need for effective contraception. However, they differ in their specific cancer characteristics and treatment timing requirements. The trials range from 18 months to several years in duration, with follow-up periods extending to track long-term outcomes such as disease-free survival and overall survival. These studies aim to improve treatment options and outcomes for patients with early-stage breast cancer who face varying levels of recurrence risk.
