Study Comparing Sacituzumab Govitecan to Physician’s Choice Treatment for Patients with Advanced Triple-Negative Breast Cancer

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What is this study about?

This clinical trial is focused on studying a type of breast cancer known as triple-negative breast cancer (TNBC). This form of cancer does not have the three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and HER2. The study is specifically looking at patients with advanced stages of this cancer, either locally advanced, inoperable, or metastatic, meaning it has spread to other parts of the body. The trial involves a medication called sacituzumab govitecan, which is being compared to other treatments chosen by doctors. Sacituzumab govitecan is a type of treatment known as an antibody-drug conjugate, which combines an antibody with a drug to target cancer cells more precisely.

The purpose of the study is to compare the effectiveness of sacituzumab govitecan with other treatments in patients who have not received previous treatment for their advanced cancer or who have been treated with certain immune therapies. The study will involve administering the treatments through an intravenous infusion, which means the medication is given directly into a vein. Patients will be monitored over a period to see how their cancer responds to the treatment. The study will also look at how long patients live and how their quality of life is affected by the treatment.

Participants in the study will receive either sacituzumab govitecan or a treatment chosen by their doctor, which may include medications like paclitaxel, gemcitabine, or carboplatin. These are all chemotherapy drugs that work by stopping the growth of cancer cells. The study aims to provide more information on the best treatment options for patients with this challenging type of breast cancer. The trial is expected to continue until 2027, allowing researchers to gather comprehensive data on the effectiveness and safety of the treatments being studied.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, health status, and previous treatments.

A baseline biopsy may be required if archival tissue is not available. This procedure must be performed before the first dose of study treatment.

2 randomization

Participants are randomly assigned to receive either sacituzumab govitecan or a treatment chosen by the physician from a list of approved options.

3 treatment administration

The treatment involves intravenous infusions of the assigned medication.

Medications include paclitaxel, gemcitabine, sacituzumab govitecan, carboplatin, and paclitaxel albumin-bound.

The specific dosage, frequency, and duration depend on the treatment plan determined by the physician.

4 monitoring and assessments

Regular monitoring is conducted to assess the response to treatment and any side effects.

Assessments include imaging tests like CT or MRI to measure disease progression.

5 end of treatment

The treatment continues until disease progression, unacceptable side effects, or other criteria for discontinuation are met.

Final assessments are conducted to evaluate the overall response to the treatment.

6 follow-up

After the treatment phase, follow-up visits are scheduled to monitor long-term health and any delayed effects of the treatment.

Who Can Join the Study?

  • Must be a female or male patient, 18 years or older, able to understand and give written consent.
  • Blood clotting tests (INR/PT and PTT or aPTT) should be within normal limits unless on blood-thinning medication.
  • If sexually active, must agree to use specific birth control methods.
  • Patients with HIV must be on HIV medication, have a stable and well-controlled infection, and meet specific health criteria.
  • Must have a specific type of breast cancer called triple-negative breast cancer (TNBC), which means the cancer does not have certain receptors (ER, progesterone receptor, and HER2).
  • Must have a tumor that is either PD-L1 negative or PD-L1 positive and previously treated with a specific type of medication if applicable.
  • Must have completed treatment for earlier stages of breast cancer, with a certain time elapsed since treatment.
  • Must have measurable disease as determined by specific imaging tests like CT or MRI.
  • Must provide a tumor sample for testing, either from a recent biopsy or stored tissue.
  • Must have a good general health status, as measured by a specific performance score.
  • Must have a life expectancy of at least 3 months.
  • Must have recovered from any major surgery for at least 2 weeks.
  • Must have adequate blood cell counts without recent support from transfusions or growth factors.
  • Must have proper liver function, with specific limits on liver enzymes and proteins.
  • Must have a certain level of kidney function, measured by creatinine clearance.

Who Cannot Join the Study?

  • Patients who have not been diagnosed with PD-L1-negative metastatic triple-negative breast cancer or PD-L1-positive metastatic triple-negative breast cancer that was previously treated with an anti-PD-(L)1 agent in a curative setting. Metastatic means the cancer has spread to other parts of the body. PD-L1 is a protein that can affect the immune system’s ability to fight cancer. Triple-negative breast cancer is a type of breast cancer that does not have three common receptors known to fuel most breast cancer growth.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Medisprof S.R.L. Cluj Napoca Romania
Centre Jean Perrin Clermont Ferrand France
Frisius Heerenveen The Netherlands
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
University Hospital Maastricht Maastricht The Netherlands
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Algemeen Ziekenhuis Klina Brasschaat Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital General Universitario Morales Meseguer Murcia Spain
Amphia Hospital Breda The Netherlands
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opole Poland
Centre De Cancerologue Du Grand Montpellier Montpellier France
Hospital Universitario Basurto Bilbao Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
MD Anderson Cancer Center Madrid Spain
Ospedale Generale Provinciale Di Macerata Macerata Italy
Spitalul Clinic Filantropia Bucharest Romania
HELIOS Klinikum Berlin-Buch GmbH Berlin Germany
Onkologicky Ustav Sv Alzbety s.r.o. Bratislava Slovakia
Nemocnica Na Okraji Mesta N.O. Partizanske Slovakia
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
University Of Debrecen Debrecen Hungary
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
IRCCS Ospedale Policlinico San Martino Genoa Italy
Alessandro Manzoni Hospital Lecco Italy
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Hospital Olomouc Olomouc Czechia
Vrije Universiteit Brussel Jette Belgium
Universita Degli Studi Di Brescia Brescia Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Fakultni Thomayerova nemocnice Prague Czechia
Centre Francois Baclesse Caen France
L’Hopital Prive Du Confluent Nantes France
Budapesti Uzsoki Utcai Korhaz Budapest Hungary
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Hospital Universitario Virgen De La Victoria Malaga Spain
Medisprof S.R.L. Cluj Napoca Romania
Ceoydysie Ujufmflrqwrjvn Sepjdbuau Woluwe-Saint-Lambert Belgium
Nwjswpwe Oeiiiyvc Imdctyucr Bratislava Slovakia
Uveqjlcjnd Mmbxogo Cencfd Hpyfjcoyyfsgojovv Hamburg Germany
Olczcoaffgtbap Lflm Gsxc Linz Austria
Ubktmnvleroy Mscphrh Chgopkb Gnquiolue Groningen The Netherlands
Akkkmwy Uog Tpivuon ndbm ovvrj Leghorn Italy
Upqopnmono Hhyjmnjt Cirkqtw Cologne Germany
Nnkjynqg Ibvnmujj Owhbnrhew Icj Mnhko Scqkktwryrglsnppbtklqfmfoxmi Itgkyhhv Brndxlpq Cracow Poland
Ayokypo Uejas Ssmmweezw Lgqast Di Bswtbkx Bologna Italy
Hpdgxikj Dy Ls Skdru Cjsm I Suyn Pry Barcelona Spain
Ujxuriahpp Ddvvi Socvy Dy Rewk Lz Szzldpti Rome Italy
Kilxpdoq Egzyfawjpkcsnrtykycwmibz Hxiiebeglhounpbop Essen Germany
Hhvnmrtn Vgva dabmqjjl Barcelona Spain
Bxfmfbkl Ujkoirvude Hvtnjcpq Cjdxsb Besançon France
Hknhnhji Uxtnojrwmqxsc dy A Chjdpq A Coruna Galicia Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
20.07.2022
Belgium Belgium
Not recruiting
20.07.2022
Czechia Czechia
Not recruiting
20.07.2022
France France
Not recruiting
20.07.2022
Germany Germany
Not recruiting
20.07.2022
Hungary Hungary
Not recruiting
20.07.2022
Italy Italy
Not recruiting
20.07.2022
Poland Poland
Not recruiting
20.07.2022
Romania Romania
Not recruiting
20.07.2022
Slovakia Slovakia
Not recruiting
20.07.2022
Spain Spain
Not recruiting
20.07.2022
The Netherlands The Netherlands
Not recruiting
20.07.2022

Trial locations

Sacituzumab Govitecan is a medication being studied for its effectiveness in treating patients with a specific type of breast cancer known as triple-negative breast cancer. This type of cancer does not have certain receptors, making it more challenging to treat. Sacituzumab Govitecan is designed to target and deliver chemotherapy directly to the cancer cells, potentially reducing the cancer’s growth and spread. The trial aims to see how well this medication works compared to other treatments chosen by doctors.

Investigated diseases:

Metastatic Triple-Negative 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 HER-2/neu gene. It is considered more aggressive and difficult to treat than other types of breast cancer. The disease can spread to other parts of the body, such as the bones, liver, or lungs, which is referred to as metastasis. Patients with this cancer may experience symptoms like lumps in the breast or underarm, changes in breast shape, or skin dimpling. The progression of the disease can vary, with some experiencing rapid advancement while others may have a slower progression. Treatment typically focuses on managing symptoms and slowing the spread of the disease.

Trial ID:
2023-504195-14-00
Protocol code:
GS-US-592-6238
NCT ID:
NCT05382299
Trial Phase:
Therapeutic confirmatory (Phase III)

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