Study to Improve Tolerance of Sacituzumab Govitecan with Loperamide and Filgrastim in Patients with Advanced Triple-Negative or Luminal Breast Cancer

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What is this study about?

This clinical trial is focused on improving the tolerance of a treatment called sacituzumab govitecan in patients with advanced forms of breast cancer, specifically metastatic triple-negative breast cancer (TNBC) and advanced HR-positive/HER2-negative breast cancer. The study aims to evaluate how well patients tolerate this treatment when it is combined with two other medications: loperamide, which is commonly used to manage diarrhea, and G-CSF (granulocyte-colony stimulating factor), which helps increase white blood cell counts. The purpose of the study is to assess the occurrence of diarrhea and a condition called neutropenia, where there is a low count of a type of white blood cell, in patients receiving this combination of treatments.

Participants in the study will receive the treatment over a period of time, and their health will be monitored to see how they respond. The study will look at the frequency and severity of diarrhea and neutropenia, as well as other potential side effects. The study will also explore how the treatment affects the size of the cancer and how long it takes for the cancer to respond to the treatment. Additionally, researchers will investigate the relationship between certain biological markers and the effectiveness of the treatment, as well as changes in the gut microbiome, which is the community of microorganisms living in the digestive tract.

The trial is designed to gather information that could help improve the management of side effects in patients with these types of breast cancer, potentially leading to better treatment outcomes. The study is expected to continue until early 2026, with the goal of providing valuable insights into the treatment of advanced breast cancer.

1 Joining the study

Upon joining the study, the patient will have signed an informed consent form, indicating understanding and agreement to participate in the trial.

The patient must meet specific health criteria, including adequate blood counts and organ function, and have completed prior cancer treatments at least two weeks before starting the trial.

2 Initial assessment

An initial assessment will be conducted to confirm the patient’s eligibility, including a review of medical history and current health status.

Imaging tests such as CT or MRI scans may be performed to document the extent of the disease.

3 Treatment initiation

The patient will begin treatment with sacituzumab govitecan, administered as an infusion. This medication is designed to target cancer cells.

To manage potential side effects, the patient will also receive loperamide hydrochloride tablets to help control diarrhea, and filgrastim injections to support white blood cell counts.

4 Treatment schedule

The treatment with sacituzumab govitecan will be given on a regular schedule, typically involving cycles of administration followed by rest periods.

Loperamide hydrochloride tablets will be taken orally as needed to manage diarrhea symptoms.

Filgrastim injections will be administered as a solution for injection or infusion to help prevent neutropenia, a condition characterized by low white blood cell counts.

5 Monitoring and assessments

Throughout the trial, the patient will undergo regular monitoring to assess the effectiveness of the treatment and manage any side effects.

This includes routine blood tests, imaging studies, and clinical evaluations to track the progression of the disease and the patient’s overall health.

6 Completion of the trial

The trial is expected to continue until January 2026, with the patient’s participation lasting as long as the treatment is beneficial and side effects are manageable.

Upon completion, final assessments will be conducted to evaluate the outcomes of the treatment and gather data for further analysis.

Who Can Join the Study?

Sign an Informed Consent Form before participating in any study-related activities.
For patients with HR positive luminal breast cancer: Must have not responded to at least one previous hormonal treatment and one CDKi4/6 treatment for cancer that has spread.
Have a disease that can be measured or evaluated, even if it only affects the bones.
If there is a suspicion of cancer spread to the brain, a brain MRI must be done, and the brain condition must be stable for at least 4 weeks without symptoms and without using anticonvulsants or steroids for at least 2 weeks before starting the study treatment.
Have adequate blood counts without needing transfusions or growth factor support within 2 weeks before starting the study drug. This means having enough hemoglobin, white blood cells, and platelets.
Have proper kidney and liver function. This includes a creatinine clearance of at least 60 ml/min, bilirubin levels within 1.5 times the normal limit, and liver enzymes (AST and ALT) within 3 times the normal limit, or 5 times if there is known liver cancer spread.
Any side effects from previous cancer treatments must be reduced to a mild level, except for hair loss or other side effects that are not considered a safety risk.
Male and female patients who can have children and engage in heterosexual intercourse must agree to use specified methods of birth control.
Complete all previous cancer treatments, including chemotherapy, radiotherapy, and major surgery, at least 2 weeks before starting the study. If antibody treatment was used, it must be completed at least 3 weeks before.
Be at least 18 years old at the time of signing the consent form.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
Have a life expectancy of at least 12 weeks.
Have cancer that cannot be surgically removed and is either locally advanced or has spread, as shown by a CT scan or MRI.
Must have been previously treated with taxanes, a type of chemotherapy, unless it is not suitable for the patient.
Have not responded to at least one, but no more than two, previous standard chemotherapy treatments for cancer that cannot be surgically removed or has spread. If the cancer spread within 12 months after earlier treatment, it counts as one of the required treatments.
For patients with TNBC: Must have a confirmed diagnosis of triple-negative breast cancer, which means less than 1% expression of estrogen and progesterone receptors and negative for HER2.
For patients with HR positive luminal breast cancer: Must have a confirmed diagnosis of estrogen and/or progesterone receptor-positive and HER2-negative breast cancer in the advanced stage.

Who Cannot Join the Study?

Patients who have a different type of cancer than the ones being studied.
Patients who have had a recent infection that requires treatment with antibiotics.
Patients who have a history of severe allergic reactions to medications.
Patients who are currently pregnant or breastfeeding.
Patients who have another serious medical condition that could interfere with the study.
Patients who have participated in another clinical trial within the last 30 days.
Patients who are unable to follow the study procedures or instructions.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital Universitari General De Catalunya	Sant Cugat Del Valles	Spain
Hospital Universitario Clínico San Cecilio	Granada	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Hospital Ruber Juan Bravo	Madrid	Spain
Complexo Hospitalario Universitario A Coruña (CHUAC), A Coruña	A Coruna Galicia	Spain
Hyxtsgbw Qezryofkakb Votaynwz	Valencia	Spain
Hbndmvlw dd Sgud Jgky Dpmzg Magutn Baywog	Sant Joan Despi	Spain
Hnkxipwy Unqerwgmlzwrj Dbugttdx	Donostia / San Sebastian	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.02.2023

Trial locations

Investigated drugs:

Sacituzumab Govitecan is a medication used in this trial to treat patients with certain types of advanced breast cancer, specifically metastatic triple-negative or luminal breast cancer. It is designed to target and deliver chemotherapy directly to cancer cells, helping to reduce the size of tumors and slow the progression of the disease.

Loperamide is included in the trial to help manage diarrhea, a common side effect of cancer treatments like sacituzumab govitecan. It works by slowing down the movement in the gut, which decreases the number of bowel movements and makes the stool less watery.

G-CSF (Granulocyte-Colony Stimulating Factor) is used in the trial to help prevent neutropenia, a condition where there is a low level of neutrophils, a type of white blood cell important for fighting infections. G-CSF stimulates the bone marrow to produce more white blood cells, reducing the risk of infection during cancer treatment.

Investigated diseases:

Advanced Triple-Negative Breast Cancer (TNBC) – This is a type of breast cancer that lacks three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER2 protein. It is considered more aggressive than other types of breast cancer because it grows and spreads faster. TNBC is more likely to be diagnosed in younger women and those with a BRCA1 gene mutation. The disease often presents as a lump in the breast and can spread to other parts of the body. It does not respond to hormonal therapy or medicines that target HER2 receptors, making treatment options more limited. The progression of TNBC can vary, but it typically requires a combination of surgery, chemotherapy, and radiation therapy.

Advanced HR[+]/HER2[-] Breast Cancer – This type of breast cancer is characterized by the presence of hormone receptors (HR-positive) and the absence of the HER2 protein. It tends to grow more slowly than HER2-positive cancers and may respond well to hormone therapy. This cancer can occur in both premenopausal and postmenopausal women. It often presents as a lump or mass in the breast and can metastasize to other parts of the body. The progression of the disease can be influenced by the cancer’s response to hormone therapy, which is a common treatment approach. The disease may require ongoing monitoring and management to control its spread and impact.

Trial ID:

2024-514060-10-00

Protocol code:

MEDOPP445

NCT ID:

NCT05520723

Trial Phase:

Therapeutic exploratory (Phase II)

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Study to Improve Tolerance of Sacituzumab Govitecan with Loperamide and Filgrastim in Patients with Advanced Triple-Negative or Luminal Breast Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?