Study on the Safety and Effectiveness of Sacituzumab Govitecan for Patients with Triple Negative Metastatic Breast Cancer

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for triple negative metastatic breast cancer, a type of breast cancer that does not have three common receptors known to fuel most breast cancer growths. The treatment being tested is called sacituzumab govitecan, also known by its code name IMMU-132. This medication is a special type of drug called an antibody-drug conjugate, which combines an antibody with a chemotherapy drug to target and kill cancer cells more effectively.

The purpose of the study is to evaluate how well sacituzumab govitecan works in treating patients with this specific type of breast cancer. Participants in the study will receive the medication through an intravenous infusion, which means it will be administered directly into a vein. The study will monitor the participants’ response to the treatment over time, looking for any changes in the size or spread of the cancer. The study will also assess the safety of the medication by keeping track of any side effects experienced by the participants.

Throughout the study, participants will have regular check-ups and imaging tests to see how the cancer is responding to the treatment. These tests will help doctors determine if the medication is effective in shrinking the tumors or stopping their growth. The study aims to provide valuable information about the potential benefits and risks of using sacituzumab govitecan for treating triple negative metastatic breast cancer.

1 joining the trial

Upon joining the trial, you will be required to sign a written informed consent form. This document confirms your agreement to participate and your understanding of the trial procedures.

If you are unable to sign the consent form yourself, a trusted person of your choice can sign on your behalf.

2 initial assessments

Before starting the treatment, several assessments will be conducted to ensure you meet the trial’s eligibility criteria. These assessments include blood tests to check your blood cell counts, liver and kidney function, and other health indicators.

A pregnancy test will be conducted for women of childbearing potential. You will also need to confirm your post-menopausal status or provide a negative pregnancy test result.

3 treatment administration

The treatment involves receiving a medication called sacituzumab govitecan, which is administered as an intravenous infusion. This means the medication is given through a needle placed in a vein.

The dosage and frequency of the medication will be determined by the trial protocol, and you will receive detailed instructions from the medical team.

4 regular monitoring

Throughout the trial, you will have regular visits to monitor your health and the effects of the treatment. These visits will include physical examinations, blood tests, and imaging studies to assess the response of your cancer to the treatment.

The primary goal is to evaluate the effectiveness of the treatment and to monitor for any side effects.

5 biopsy procedures

You will be asked to undergo biopsy procedures before, during, and after the treatment. A biopsy involves taking a small sample of tissue from your tumor to study the effects of the treatment at a cellular level.

The biopsy will be performed on a metastatic site that is easily accessible, unless it is a bone metastasis. If the primary tumor site is accessible and has not been previously irradiated, it may be used for the biopsy.

6 end of treatment

At the end of the treatment period, a final assessment will be conducted to evaluate the overall response to the treatment and to document any changes in your condition.

You will receive guidance on follow-up care and any additional steps that may be necessary based on the trial’s findings.

Who Can Join the Study?

The patient must have signed a written informed consent before any trial-specific procedures. If the patient is unable to give written consent, a trusted person can confirm the patient’s consent in writing.
The patient must have adequate blood and organ function:
- Hemoglobin (a protein in red blood cells) must be at least 9 g/dL.
- Absolute neutrophil count (a type of white blood cell) must be at least 1500/mm³ or 1.5 x 10⁹/L.
- Platelets (cells that help with blood clotting) must be at least 100,000/μL without recent transfusions or growth factor support.
- Creatinine clearance (a measure of kidney function) must be at least 30 mL/min.
- AST and ALT (liver enzymes) must be no more than 2.5 times the upper limit of normal, or 5 times if there are liver metastases.
- Total bilirubin (a substance made by the liver) must be no more than 1.5 times the upper limit of normal, or 3 times if there is Gilbert’s Syndrome or liver metastases.
- Serum albumin (a protein in the blood) must be more than 3 g/dL.
The patient must have a negative hepatitis B surface antigen test and a negative hepatitis C virus antibody test, or a negative hepatitis C RNA test if the antibody test is positive.
Female patients must show evidence of being post-menopausal or have a negative pregnancy test before starting the study treatment.
Women of childbearing potential and male patients must agree to use adequate contraception during the trial and for a period after completing treatment (6 months for women, 3 months for men).
The patient must be affiliated with a social security system or equivalent.
The patient must be willing and able to follow the trial protocol, including treatment, scheduled visits, and examinations.
The patient must be at least 18 years old.
The patient must have triple negative breast cancer that is locally advanced and inoperable or has spread to other parts of the body. The disease must have progressed after certain treatments.
The patient must have been previously treated with a taxane (a type of chemotherapy drug).
The patient must have measurable disease as defined by specific criteria (RECIST v1.1).
The patient must agree to have biopsies (tissue samples) taken before, during, and after treatment.
The patient must have a metastatic site (cancer that has spread) that is easy to biopsy, except for bone metastasis.
The patient must have an ECOG performance status of 0, 1, or 2, which measures the ability to perform daily activities.
The patient must have a life expectancy of at least 12 weeks.

Who Cannot Join the Study?

Patients who have not been diagnosed with triple negative metastatic breast cancer cannot participate.
Patients whose disease has not progressed on first-line chemotherapy for locally advanced breast cancer or metastatic disease are excluded.
Patients who have not received (neo)adjuvant chemotherapy for early triple negative breast cancer or whose disease did not progress within 6 months after the end of curative treatments are excluded.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial groups are excluded.
Patients who are not considered part of the vulnerable population selected for the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Jean Perrin	Clermont Ferrand	France
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Centr Georges Francois Leclerc	Dijon	France

Other Sites

Site Name	City	Country
CHC MontLegia	Liege	Belgium
Centre Hospitalier De Cholet	Cholet	France
Hopital Prive Des Cotes D’armor	Plerin	France
Grand Hopital De Charleroi	Charleroi	Belgium
Clinique Pasteur Lanroze	Brest	France
Immobiliere De Nancy	Nancy	France
Groupement De Cooperation Sanitaire Risssa Recherche & Innovation Sante Sarcelles	Sarcelles	France
Societe De Recherche Oncologique Clinique 37	Chambray Les Tours	France
Clinique Saint-Pierre Ottignies (CSPO)	Ottignies	Belgium
Chrcnlanx Uilikvumuzvynr Sxhokawnj	Woluwe-Saint-Lambert	Belgium
Cambhv Hdutevimbjz Eh Utrwrocfympiu Dx Lyezntz	Limoges	France
Abitlvndgj Pdvzqang Hezcqepk Di Pqbwy	Paris	France
Bckwuxxd Ubfvcbdgej Hmegmalt Cptiye	Besançon	France
Celgme Luol Blqpsa	Lyon	France
Iekaiyak ds Cmnkozbehyya Hmhbbyepwuq Ucuhdwzdnpohl df Smelx Etgzgyl (jtvblrq	Saint Priest En Jarez	France
Ilqkzgxp Pfmpeocpamfvlgz Cylxhn Cruuvc	Marseille	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	02.01.2023
France	Not recruiting	02.01.2023

Trial locations

Investigated Drugs:

Sacituzumab Govitecan

Sacituzumab Govitecan is a type of medication used in this clinical trial to treat patients with a specific kind of breast cancer known as triple-negative metastatic breast cancer. This medication is designed to target and attach to cancer cells, delivering a powerful drug directly to them. This helps to kill the cancer cells while trying to limit damage to normal, healthy cells. The goal of using sacituzumab govitecan in this trial is to see how well it works in shrinking tumors or stopping them from growing in patients whose cancer has returned or continued to grow after previous treatments.

Investigated Diseases:

Triple negative breast cancer

Triple Negative Metastatic Breast Cancer – 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. The disease often progresses quickly, with cancer cells spreading to other parts of the body, such as the bones, liver, or lungs. As it advances, patients may experience symptoms like pain, fatigue, and weight loss. The absence of these receptors means that common hormonal therapies are ineffective, making treatment options more limited. The progression of the disease is typically monitored through imaging tests to assess the spread and growth of tumors.

Trial ID:

2022-502369-10-00

Protocol code:

UC-BCG-2204

NCT ID:

NCT05552001

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Effectiveness of Sacituzumab Govitecan for Patients with Triple Negative Metastatic Breast Cancer

What is this study about?

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