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A study of sacituzumab govitecan and atropine to improve tolerance in patients with advanced triple-negative or hormone receptor-positive/HER2-negative breast cancer

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What is this study about?

This study focuses on individuals with advanced triple-negative breast cancer or hormone receptor-positive/HER2-negative breast cancer. These are specific types of cancer characterized by the absence of certain markers on the surface of the cancer cells. The research aims to determine if adding atropine can help people better tolerate the medication sacituzumab govitecan, which is an intravenous drug, meaning it is delivered directly into a vein through a liquid solution. To manage certain side effects, filgrastim may also be used via subcutaneous injection, which is an injection given just under the skin.

The purpose of the study is to evaluate how often and how severely diarrhea occurs during the first two treatment cycles when sacituzumab govitecan is used alongside atropine. Participants will receive these medications as part of their treatment plan, and the study will monitor various aspects of health and how the body reacts to the drugs over time.

Who Can Join the Study?

  • You or your legal representative must understand the study’s purpose and sign a written consent form, which is a legal document agreeing to participate.
  • You must have advanced breast cancer that cannot be removed with surgery, and the cancer must have progressed (continued to grow or spread) after receiving no more than two previous types of chemotherapy (drugs used to kill cancer cells).
  • If you previously had a specific type of drug called a TROP2 ADC or a topoisomerase I inhibitor, you can only join if it has been at least 12 months since you completed that treatment.
  • Your cancer must be able to be measured or evaluated using standard medical imaging rules.
  • You must have healthy bone marrow (the part of the body that makes blood cells), liver, and kidneys (the organs that filter waste).
  • Your blood counts must be sufficient without needing extra help from transfusions (receiving blood from a donor) or growth factors (medicines that help make more blood cells) for two weeks before starting.
  • Your kidney function must be adequate, measured by how well your kidneys filter waste from your blood.
  • Your liver function must be within a safe range, specifically looking at levels of a substance called bilirubin and liver enzymes.
  • People with Gilbert’s syndrome (a common, harmless liver condition) may participate if their bilirubin levels are within a specific safe limit.
  • You must be willing to provide recent tumor tissue samples and biological samples like blood and stool at certain times.
  • Any side effects from previous cancer treatments must have mostly cleared up, meaning they are at a very low grade (severity level).
  • Women of childbearing age must have a negative pregnancy test and agree to use highly effective birth control (methods to prevent pregnancy) during the study and for six months after.
  • Women participating must not donate eggs or breastfeed during the study period.
  • Men who are sexually active must use contraception (methods to prevent pregnancy) or be surgically unable to have children, and must not donate sperm during the study.
  • You must be able to attend all scheduled doctor visits and follow-up appointments.
  • You must be at least 18 years old.
  • You must have a good performance status, which means you are physically able to carry out daily activities with minimal assistance.
  • You must have a life expectancy of at least 12 weeks.
  • Your cancer must be confirmed by a CT scan (a detailed X-ray) or MRI (a scan using magnets) and be considered unresectable, meaning it cannot be cured by surgery alone.
  • For triple-negative breast cancer (TNBC), your cancer must be confirmed by a biopsy to lack three specific markers: estrogen receptor (ER), progesterone receptor (PgR), and HER2.
  • For HR(+)/HER2(–) breast cancer, your cancer must have hormone receptors (HR) but lack the HER2 protein.
  • Patients with HR(+)/HER2(–) breast cancer must have had their cancer progress after receiving at least one type of endocrine therapy (hormone treatment) and a CDK4/6 inhibitor (a specific type of targeted cancer medicine).

Who Cannot Join the Study?

  • You cannot be participating in any other medical study, whether it involves testing a treatment or just observing patients, until you have completed the safety visit for this study.
  • You cannot have a serious active lung condition, such as a current infection or a sudden worsening of COPD (a chronic lung disease that makes it hard to breathe) or asthma.
  • You cannot have a history of significant bleeding, thrombosis (blood clots), intestinal obstruction (a blockage in the intestines), or gastrointestinal perforation (a hole in the stomach or intestines) within the last six months.
  • You cannot have inflammatory bowel disease, such as Crohn’s disease or ulcerative colitis (conditions that cause swelling and sores in the digestive tract), or any condition that causes regular diarrhea.
  • You cannot have any other serious health problems or abnormal laboratory test results that make it unsafe for you to participate in the study.
  • You cannot have an active infection with hepatitis B or hepatitis C (viruses that affect the liver), unless certain specific medical criteria for past or controlled infections are met.
  • You cannot have an active primary immunodeficiency (a condition where the immune system cannot fight infections) or an uncontrolled HIV infection. People with HIV on stable medication and with healthy blood counts may be allowed.
  • You cannot have any other active infection that is not under control at the time you join the study.
  • You cannot have received a live or weakened vaccine within 30 days before your first dose of study treatment.
  • You cannot be pregnant or breastfeeding, and you must be willing to use highly effective contraception (methods to prevent pregnancy).
  • You cannot have received any approved or experimental cancer treatments within 14 days before starting the study treatment.
  • You cannot have leptomeningeal disease (cancer that has spread to the fluid surrounding the brain and spine) or active, uncontrolled cancer in the central nervous system (the brain and spinal cord).
  • You cannot have another active cancer, or have had a cancer within the last three years, except for certain common skin cancers or early-stage cervical cancer that has been treated.
  • You cannot have a known allergy or hypersensitivity (an extreme allergic reaction) to the study drugs or any of their ingredients.
  • You cannot be at risk for urinary retention (the inability to empty the bladder), have a history of glaucoma (increased pressure in the eye), or have myasthenia gravis (a disease that causes muscle weakness), as these conditions make the study medicine unsafe.
  • You cannot be taking any prohibited medications that are listed in the study rules.
  • You cannot have had radiotherapy (radiation treatment for cancer) within two weeks of starting the study, or within four weeks if the radiation was to the brain or spine.
  • You cannot have had a major surgery or a serious injury within 14 days before the first dose, and you should not expect to need major surgery during the study.
  • You cannot have a history of unstable angina (chest pain that changes in pattern), myocardial infarction (a heart attack), heart failure, or certain irregular heart rhythms within the last six months.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Navarra Pamplona Spain
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal

Other Sites

Site Name City Country Status
Hospital Universitario Ramon Y Cajal Madrid Spain
Hospital Universitari General De Catalunya Sant Cugat Del Valles Spain
Hospital Universitario Severo Ochoa Leganes Spain
Hospital Universitario 12 De Octubre Madrid Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Hospital Universitario De Toledo Ute Toledo Spain
Hvfvnlyy Qlhoukcwscd Vuliepex Valencia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Portugal Portugal
Not yet recruiting
01.04.2026
Spain Spain
Not yet recruiting
01.04.2026

Trial locations

Investigated drugs:

Sacituzumab govitecan is a targeted therapy used to treat advanced types of breast cancer. It works by delivering a powerful medicine directly to cancer cells to help stop them from growing.

Atropine is a medication used in this study to help improve how well patients tolerate the cancer treatment. Its specific role is to help reduce or prevent side effects, such as diarrhea, that may occur during therapy.

Filgrastim is a medication used as background therapy to help the body produce more white blood cells. This helps support the immune system and protects the body against infections during cancer treatment.

Triple-negative breast cancer – This is a type of breast cancer that lacks three specific receptors commonly found on normal breast cells. Because it lacks these receptors, the cancer cells do not respond to hormone therapies or certain targeted drugs. This condition often grows more quickly than other types of breast cancer. It can spread from the original site in the breast to other parts of the body. The disease is characterized by its aggressive nature and tendency to recur.

Trial ID:
2025-524109-33-00
Protocol code:
MEDOPP824
Trial Phase:
Therapeutic exploratory (Phase II)

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