Study of Sacituzumab Govitecan and Pembrolizumab for Patients with Untreated Advanced Triple-Negative Breast Cancer

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What is this study about?

This clinical trial is focused on studying treatments for Triple-Negative Breast Cancer that has spread to other parts of the body or cannot be removed by surgery. The study involves the use of a medication called Sacituzumab Govitecan in combination with Pembrolizumab, a type of treatment known as a monoclonal antibody. The trial will compare this combination to other treatments chosen by doctors, also combined with Pembrolizumab. The purpose of the study is to evaluate the effectiveness of these treatments in patients whose tumors express a protein called PD-L1.

Participants in the study will receive their assigned treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will follow participants over a period to observe how the cancer responds to the treatment and to monitor any side effects. The trial aims to understand how long the treatment can prevent the cancer from getting worse and to assess the overall survival of the participants.

Throughout the study, participants will undergo regular check-ups and tests, such as imaging scans, to track the progress of their treatment. The study will also collect information on the quality of life of participants, including their physical functioning and any symptoms they experience. This information will help researchers determine the best treatment options for patients with Triple-Negative Breast Cancer in the future.

1 initial treatment phase

Upon joining the study, the patient will begin the initial treatment phase. This involves receiving medications through an intravenous infusion.

The medications include sacituzumab govitecan and pembrolizumab. Sacituzumab govitecan is administered as a 200 mg powder for solution, and pembrolizumab is given as a 25 mg/mL concentrate for solution.

The frequency and duration of these infusions will be determined by the study protocol and the treating physician.

2 treatment of physician's choice

In addition to the initial medications, the patient may receive treatment of the physician’s choice, which could include other medications such as paclitaxel, carboplatin, or gemcitabine.

Paclitaxel is provided as a 6 mg/mL concentrate, carboplatin as a 10 mg/mL concentrate, and gemcitabine as a 38 mg/mL concentrate, all for intravenous infusion.

The specific choice of medication and its administration schedule will be tailored to the patient’s condition and response to treatment.

3 ongoing assessment

Throughout the trial, the patient’s progress will be monitored through regular assessments. These assessments will evaluate the effectiveness of the treatment and any side effects experienced.

The primary goal is to measure progression-free survival, which is the time from the start of treatment until the disease progresses or the patient passes away.

Secondary assessments will include overall survival, response rates, and the duration of response, among other health and quality of life measures.

4 completion of trial

The trial is expected to continue until February 2027, with the patient’s participation lasting as long as the treatment is beneficial and safe.

Upon completion, the patient’s overall health and treatment outcomes will be reviewed to determine the next steps in their care.

Who Can Join the Study?

  • Participants must be 18 years of age or older and able to understand and give written consent.
  • Participants must have a blood test result called INR/PT and PTT or aPTT that is less than or equal to 1.5 times the normal limit, unless they are receiving treatment to prevent blood clots.
  • Participants who can have children and are sexually active must agree to use specific methods of birth control.
  • Participants with HIV must be on medication for HIV and have a well-controlled infection, meaning their CD4+ T-cell count is 350 or higher, and their HIV RNA level is very low for at least 12 weeks before the study.
  • Participants must have triple-negative breast cancer (TNBC) that is advanced or has spread to other parts of the body, and their tumors must be PD-L1 positive. They should not have received previous treatment for advanced disease.
  • Participants must have completed treatment for earlier stages of breast cancer at least 6 months before joining the study.
  • Participants with newly diagnosed metastatic TNBC are eligible.
  • Participants must have a tumor sample tested to confirm TNBC and PD-L1 status.
  • Participants must have measurable disease as seen on a CT or MRI scan.
  • Participants must provide a tumor sample for testing, either from a recent biopsy or stored tissue.
  • Participants must have a performance status score of 0 or 1, which indicates they are fully active or have some symptoms but can still do light work.
  • Participants must have a life expectancy of at least 3 months.
  • Participants must have recovered from major surgery for at least 2 weeks.
  • Participants must have adequate blood counts without needing transfusions or growth factor support.
  • Participants must have adequate liver function, with specific blood test results within certain limits.
  • Participants must have a creatinine clearance of 30 mL/min or higher, which is a measure of kidney function.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have received certain treatments that might interfere with the study.
  • Patients with serious health conditions that could make participation unsafe.
  • Patients who are unable to follow the study procedures or attend required visits.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients with allergies to the study medications.
  • Patients with infections that are not well controlled.
  • Patients with a history of certain heart conditions.
  • Patients who have had a recent surgery that could affect the study.

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
Centre Jean Perrin Clermont Ferrand France
Frisius Heerenveen The Netherlands
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Orszagos Onkologiai Intezet Budapest Hungary
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Universitair Ziekenhuis Gent Gent 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
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opole Poland
Centre De Cancerologue Du Grand Montpellier Montpellier France
MD Anderson Cancer Center Madrid Spain
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH Moenchengladbach Germany
Marienhospital Bottrop gGmbH Bottrop Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
Azienda USL Toscana Centro Prato Italy
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Rotkreuzklinikum Muenchen gGmbH Munich Germany
Universita Degli Studi Di Brescia Brescia Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Centre Francois Baclesse Caen France
Hospital Universitario Virgen De La Victoria Malaga Spain
Centre Catherine de Sienne Nantes France
Ijlixcqn Rcprpxzr Dd Cdvsgq Du Mriokzkvzpv Montpellier France
Ctynge Lamo Bjuhnv Lyon France
Ugoksaihzz Mxfohon Cfjpsj Hxcknkfnnfmwkzscu Hamburg Germany
Oztrejqrelyool Lskc Gyvv Linz Austria
Ufyzkkpgkcvf Mlgopna Ccqwzbj Gwzfzcvyh Groningen The Netherlands
Apmbtdj Uja Tplbdrk npfr ocsot Leghorn Italy
Ukytxawkxa Hrfojchp Cqxhdjg Cologne Germany
Bwoxxrmw Ubbrivwzpz Hqgwxczd Chtvrr Besançon France
Eirldlz Uwycwrjojuvv Muzfxse Ckknjpz Rufjicqfn (mmqvyth Mkb Rotterdam The Netherlands
Gkovmbdvsdohevdrt Vinxiyrqu Powv Aqqapb Ehscuzub Oxfwsl Kuypvt Gyor Hungary
Nfmrhwue Indundmm Ompcesfyg Ijj Mdqne Saobzyofiaevkzkogihivivamjut Idljwqtg Btxeljts Cracow Poland
Amivoee Uokfb Syjioqolk Lhdstp Dh Bdxnzhl Bologna Italy
Upsknmpyqyufyq Cdsfnbo Kvsdgzxxz Gdansk Poland
Htjadanl Dn Ls Szjme Cads I Skvi Pto Barcelona Spain
Hvtwxsee Vrhn dljgkvfh Barcelona Spain
Iuazqvby Pflyealrrqrcffk Cecoqa Cprekg Marseille France
Hljynwvm Umflhmcnrmtcm dq A Ckdcnl 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
13.09.2022
Belgium Belgium
Not recruiting
13.09.2022
Czechia Czechia
Not recruiting
13.09.2022
France France
Not recruiting
13.09.2022
Germany Germany
Not recruiting
13.09.2022
Hungary Hungary
Not recruiting
13.09.2022
Italy Italy
Not recruiting
13.09.2022
Poland Poland
Not recruiting
13.09.2022
Spain Spain
Not recruiting
13.09.2022
The Netherlands The Netherlands
Not recruiting
13.09.2022

Trial locations

Sacituzumab Govitecan is a medication used in this trial to treat patients with a specific type of breast cancer known as triple-negative breast cancer. It is designed to target and deliver chemotherapy directly to cancer cells, helping to destroy them while minimizing damage to healthy cells.

Pembrolizumab is an immunotherapy drug used in this trial. It works by helping the immune system recognize and attack cancer cells. Pembrolizumab is often used in combination with other treatments to enhance its effectiveness in fighting cancer.

PD-L1 Positive Metastatic Triple-Negative Breast Cancer – This is a type of breast cancer characterized by the absence of estrogen and progesterone receptors and the lack of excess HER2 protein. It is termed “triple-negative” because it does not express these three common receptors, making it more challenging to treat. The cancer is considered metastatic when it has spread beyond the breast to other parts of the body. PD-L1 positivity indicates that the cancer cells express the PD-L1 protein, which can help them evade the immune system. This type of cancer tends to grow and spread more quickly than other forms of breast cancer. It is often diagnosed at a later stage due to its aggressive nature.

Trial ID:
2023-504194-21-00
Protocol code:
GS-US-592-6173
NCT ID:
NCT05382286
Trial Phase:
Therapeutic confirmatory (Phase III)

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