Exploring sacituzumab govitecan for HER2-negative breast cancer care

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    What is this study about?

    This study is evaluating a new treatment for patients with a certain type of breast cancer (HER2-negative) who have not had a complete response to initial chemotherapy. Participants are randomly assigned to receive the investigational drug sacituzumab govitecan or a treatment of their physician’s choice, which may be another type of chemotherapy with capecitabinalub, carboplatin or cisplatin. The study is designed to compare the effectiveness of these approaches in preventing cancer recurrence. Patients may also receive hormone therapy if needed. Patients’ safety and response to treatment are being closely monitored throughout the study.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Graz , Austria

      Graz , Austria

      Innsbruck , Austria

      Krems , Austria

      Linz , Austria

      Salzburg , Austria

      St. Pu00f6lten , Austria

      Vu00f6cklabruck , Austria

      Wels , Austria

      Wiener Neustadt , Austria

      Brasschaat , Belgium

      Liu00e8ge , Belgium

      Angers , France

      Avignon , France

      Bordeaux , France

      Bordeaux , France

      Caen , France

      Dijon , France

      Lille , France

      Limoges , France

      Lyon , France

      Marseille , France

      Montpellier , France

      Nantes , France

      Nice , France

      Paris , France

      Paris , France

      Pau , France

      Plu00e9rin , France

      Reims , France

      Rennes , France

      Rouen , France

      Strasbourg , France

      Toulouse , France

      Vandoeuvre-lu00e8s-Nancy , France

      Villejuif , France

      Freiburg , Germany

      Bu00f6blingen , Germany

      Esslingen am Neckar , Germany

      Karlsruhe , Germany

      Karlsruhe , Germany

      Mannheim , Germany

      Nu00fcrtingen , Germany

      Reutlingen , Germany

      Ulm , Germany

      Villingen-Schwenningen , Germany

      Esslingen , Germany

      Augsburg , Germany

      Bamberg , Germany

      Erlangen , Germany

      Landshut , Germany

      Traunstein , Germany

      Berlin , Germany

      Fu00fcrstenwalde , Germany

      Neuruppin , Germany

      Bad Nauheim , Germany

      Frankfurt , Germany

      Frankfurt , Germany

      Frankfurt , Germany

      Hanau , Germany

      Kassel , Germany

      Kassel , Germany

      Offenbach , Germany

      Wiesbaden , Germany

      Rostock , Germany

      Braunschweig , Germany

      Georgsmarienhu00fctte , Germany

      Hannover , Germany

      Oldenburg , Germany

      Stade , Germany

      Wolfenbu00fcttel , Germany

      Bielefeld , Germany

      Aachen , Germany

      Bottrop , Germany

      Dortmund , Germany

      Du00fcsseldorf , Germany

      Erkelenz , Germany

      Essen , Germany

      Essen , Germany

      Ku00f6ln , Germany

      Ku00f6ln , Germany

      Mu00fcnster , Germany

      Recklinghausen , Germany

      Wuppertal , Germany

      Koblenz , Germany

      Mainz , Germany

      Mayen , Germany

      Speyer , Germany

      Worms , Germany

      Saarbru00fccken , Germany

      Halle , Germany

      Magdeburg , Germany

      Stendal , Germany

      Chemnitz , Germany

      Dresden , Germany

      Rodewisch , Germany

      Torgau , Germany

      Gera , Germany

      Nordhausen , Germany

      Suhl , Germany

      Berlin , Germany

      Bremen , Germany

      Deggendorf , Germany

      Hamburg , Germany

      Mu00fcnchen , Germany

      Ravensburg , Germany

      Aviano , Italy

      Bolzano , Italy

      Genova , Italy

      Milano , Italy

      Novara , Italy

      Pavia , Italy

      Trento , Italy

      Albacete , Spain

      Alcoy , Spain

      Alicante , Spain

      Barcelona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Castellu00f3n De La Plana , Spain

      Cu00e1ceres , Spain

      Galdakao , Spain

      Jaen , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Murcia , Spain

      Mu00e1laga , Spain

      Ourense , Spain

      Palma de Mallorca , Spain

      Reus , Spain

      Santa Cruz de Tenerife , Spain

      Sevilla , Spain

      Sevilla , Spain

      Valencia , Spain

      Valencia , Spain

      Valladolid , Spain

      Valu00e8ncia , Spain

      You can join this study in:

      : !!dwa.

      Netherlands: ‘s-Gravenhage, ‘s-Hertogenbosch, Alkmaar, Almelo, Almere, Amersfoort, Amsterdam, Apeldoorn, Arnhem, Beek, Bergen op Zoom, Beverwijk, Breda, Delft, Deventer, Dirksland, Doetinchem, Dordrecht, Ede, Eindhoven, Enschede, Geleen, Goes, Gouda, Groningen, Haarlem, Harderwijk, Heemstede, Heerlen, Heeze, Helmond, Hilversum, Hoofddorp, Hoogeveen, Hoorn, Leeuwarden, Leiden, Leiden, RC, Leiderdorp, Maastricht, Nieuwegein, Nijmegen, Roermond, Roosendaal, Rotterdam, Sneek, Terneuzen, The Hague, Tiel, Tilburg, Uden, Utrecht, Veldhoven, Venlo, Zaandam, Zutphen, Zwolle.

      Spain: A Coruña, Albacete, Alcalá de Henares, Alcobendas, Alcorcón, Alcoy, Algeciras, Alicante, Almería, Alzira, Ávila, Badajoz, Badalona, Barakaldo, Barcelona, Benalmádena, Bilbao, Boadilla del Monte, Buenos Aires, Burgos, Burjassot, Cáceres, Cádiz, Cartagena, Castellón de la Plana, Castilleja de la Cuesta, Collado Villalba, Córdoba, Coslada, Elche, Esplugues de Llobregat, Ferrol, Fuenlabrada, Galdakao, Gandia, Getafe, Getxo, Gijón, Girona, Granada, Huelva, Jaén, Jerez de la Frontera, L’Hospitalet de Llobregat, Laredo, Las Palmas de Gran Canaria, León, Lleida, Lugo, Madrid, Majadahonda, Málaga, Manises, Manresa, Marbella, Mérida, Móstoles, Murcia, Ourense, Oviedo, Palma, Pamplona, Parla, Ponferrada, Pontevedra, Pozuelo de Alarcón, Puerto De Sagunto, Reus, Rincón de la Victoria, Sabadell, Salamanca, Salt, San Cristóbal de La Laguna, San Pedro Alcántara, San Sebastián, San Sebastián de los Reyes, Sant Adrià de Besòs, Sant Andreu de La Barca, Sant Cugat del Vallès, Sant Cugat del Vallès, Sant Joan d’Alacant, Sant Joan Despí, Santa Cruz de Tenerife, Santander, Santiago de Compostela, Saragossa, Segovia, Seville, Talavera de la Reina, Terrassa, Teruel, Toledo, Tomelloso, Torrejón de Ardoz, Torrevieja, Valencia, Valladolid, Vigo, Villajoyosa, Villamartin, Villareal, Vitoria, Xàtiva, Zamora.

      Denmark: Aabenraa, Aalborg, Aarhus, Copenhagen, Esbjerg, Frederiksberg, Gandrup, Glostrup, Hellerup, Herlev, Herning, Holbæk, Holstebro, Hvidovre, Køge, Kolding, Næstved, Odense, Roskilde, Slagelse, Søborg, Sønderborg, Svendborg, Vejle, Viborg.

      Germany: Aachen, Altenburg, Ansbach, Aschaffenburg, Augsburg, Bad Abbach, Bad Bentheim, Bad Berka, Bad Bramstedt, Bad Doberan, Bad Friedrichshall, Bad Homburg vor der Höhe, Bad Krozingen, Bad Nauheim, Bad Oeynhausen, Bad Reichenhall, Bad Saarow, Bad Schönborn, Bad Soden, Baden, Bamberg, Bayreuth, Bergisch Gladbach, Berlin, Bielefeld, Bitburg, Blankenfelde-Mahlow, Böblingen, Bochum, Bonn, Bottrop, Bramsche, Brandenburg an der Havel, Braunschweig, Bremen, Buxtehude, Chemnitz, Cloppenburg, Coburg, Cologne, Coswig, Cottbus, Dachau, Darmstadt, Datteln, Deggendorf, Deggingen, Delitzsch, Dessau-Roßlau, Donauwörth, Dortmund, Dresden, Duisburg, Dülmen, Düsseldorf, Eggenfelden, Eichstätt, Elsterwerda, Erbach im Odenwald, Erding, Erfurt, Erkelenz, Erlangen, Eschweiler, Essen, Esslingen am Neckar, Flensburg, Frankfurt, Freiburg im Breisgau, Friedrichshafen, Friedrichsthal, Fulda, Fürstenwalde, Fürth, Garmisch-Partenkirchen, Gauting, Geesthacht, Geilenkirchen, Gelnhausen, Georgsmarienhütte, Gera, Giessen, Goch, Gommern, Görlitz, Göttingen, Greifswald, Großhansdorf, Gütersloh, Haar, Hagen, Halle, Hamburg, Hamm, Hanau, Hanover, Heidelberg, Heilbronn, Heinsberg, Hemer, Herne, Hildesheim, Hochheim am Main, Hohenmölsen, Homburg, Hoppegarten, Höxter, Idar-Oberstein, Immenhausen, Immenstadt im Allgäu, Jena, Jerichow, Kaiserslautern, Karlsruhe, Kassel, Kehl, Kempten, Kiel, Kirchheim unter Teck, Koblenz, Konstanz, Krefeld, Kronach, Lahr, Landsberg am Lech, Landshut, Langen, Langenau, Lebach, Leipzig, Lemgo, Leverkusen, Limburg, Lingen, Löhne, Löwenstein, Lübeck, Lüdenscheid, Ludwigsburg, Ludwigshafen, Lüneburg, Magdeburg, Mainz, Mannheim, Marburg, Markkleeberg, Mayen, Memmingen, Merseburg, Meschede, Mettmann, Minden, Moers, Mönchengladbach, Mörfelden-Walldorf, Munich, Münnerstadt, Münster, Mutlangen, Naunhof, Neu-Isenburg, Neumünster, Neuruppin, Neuss, Nordhausen, Northeim, Nuremberg, Nürtingen, Offenbach am Main, Offenburg, Oldenburg, Oldenburg In Holstein, Osnabrück, Paderborn, Papenburg, Passau, Peine, Pforzheim, Pirna, Planegg, Pohlheim, Potsdam, Quedlinburg, Radeberg, Ratingen, Ravensburg, Recklinghausen, Regensburg, Remscheid, Rendsburg, Reutlingen, Rheine, Riesa, Rodewisch, Rosenheim, Rostock, Rüdersdorf, Rüsselsheim am Main, Saarbrücken, Saarlouis, Sande, Sankt Augustin, Schleswig, Schönau am Königssee, Schönebeck, Schwäbisch Hall, Schweinfurt, Schwerin, Selters, Siegburg, Siegen, Simmern, Sindelfingen, Singen, Solingen, Speyer, Stade, Stendal, Stralsund, Stuhr, Stuttgart, Suhl, Sulzbach-Rosenberg, Templin, Torgau, Traunstein, Trier, Troisdorf, Tübingen, Tuttlingen, Ulm, Unterhaching, Velbert, Villingen-Schwenningen, Wallerfing, Wangen im Allgäu, Weiden in der Oberpfalz, Wermsdorf, Wertheim, Wesel, Westerstede, Wiesbaden, Wipperfürth, Witten, Wolfenbüttel, Wolfsburg, Worms, Wuppertal, Würselen, Würzburg, Zwickau.

      Belgium: Aalst, Alken, Anderlecht, Antwerp, Arlon, Ath, Beerzel, Belgium, Beuzet, Bonheiden, Bouge, Brasschaat, Bruges, Brussels, Charleroi, Dendermonde, Edegem, Esneux, Genk, Ghent, Haine-Saint-Paul, Ham-sur-Heure-Nalinnes, Hamme-Mille, Hasselt, Jette, Kortrijk, Leuven, Libramont-Chevigny, Liège, Lier, Linkebeek, Loverval, Lubbeek, Mechelen, Melsbroek, Mol, Mons, Montigny-le-Tilleul, Namur, Noirefontaine, Ostend, Ottignies-Louvain-la-Neuve, Overpelt, Pelt, Roeselare, Saint-Nicolas, Sint-Niklaas, Thuin, Tienen, Tournai, Tubiza, Turnhout, Verviers, West Flanders, Wilrijk, Woluwe-Saint-Lamber, Yvoir, Zaventem.

      United Kingdom: Aberdeen, Airdrie, Barnsley, Barry, Basingstoke, Bath, Bebington, Bedford, Belfast, Bellshill, Birmingham, Blackburn, Blackpool, Bournemouth, Bradford, Brighton and Hove, Bristol, Burton upon Trent, Bury Saint Edmunds, Cambridge, Cannock, Canterbury, Cardiff, Chelmsford, Cheltenham, Chesterfield, Chichester, Chinnor, Chippenham, Chorley, Clydebank, Coatbridge, Colchester, Corby, Cottingham, Coventry, Craigavon, Derby, Doncaster, Dudley, Dundee, Durham, East Kilbride, Eastleigh, Edinburgh, Exeter, Felixstowe, Frimley, Gillingham, Glasgow, Gloucester, Gorleston-on-Sea, Great Yarmouth, Guildford, Hackensack, Harefield, Harlow, Harrow, Hexham, High Wycombe, Hoddesdon, Honiton, Huddersfield, Inverness, Ipswich, Isleworth, Keighley, King’s Lynn, Kingston upon Hull, Lancaster, Leamington Spa, Leeds, Leicester, Lincoln, Liskeard, Liverpool, London, Londonderry, Luton, Macclesfield, Maidstone, Manchester, Middlesbrough, Motherwell, Nantwich, Newcastle upon Tyne, Newmarket, Newquay, Northampton, Norwich, Nottingham, Oswestry, Oxford, Penarth, Penzance, Perth, Peterborough, Plymouth, Poole, Portsmouth, Prescot, Preston, Reading, Redhill, Rhyl, Rochdale, Romford, Rotherham, Salford, Sheffield, Shipley, South Shields, Southampton, Stafford, Stanmore, Stevenage, Stockport, Stockton-on-Tees, Stoke-on-Trent, Sunderland, Sutton, Sutton Coldfield, Sutton-in-Ashfield, Swansea, Swinton, Taunton, Thetford, Torquay, Trowbridge, Truro, Wakefield, Walsall, Warwick, Watford, West Yorkshire, Westbury-on-Trym, Westcliff-on-Sea, Wigan, Winchester, Windsor, Wirral, Wishaw, Withington, Wolverhampton, Wrexham, Wythenshawe, Yate, Yeovil, York.

      Italy: Acquaviva delle Fonti, Alessandria, Ancona, Arezzo, Arzignano, Ascoli Piceno, Avellino, Aviano, Baggiovara, Bari, Bassano del Grappa, Battipaglia, Bellaria – Igea Marina, Bergamo, Bologna, Bolzano, Borgo San Lorenzo, Brescia, Brindisi, Busto Arsizio, Cagliari, Candiolo, Carpi, Carrara, Casatenovo, Caserta, Cassino, Castelfranco Veneto, Castellana Grotte, Catania, Catanzaro, Cefalù, Chieti, Como, Cona, Cosenza, Cremona, Cuneo, Empoli, Faenza, Ferrara, Florence, Foggia, Foligno, Genoa, Grosseto, Gussago, L’Aquila, La Spezia, Lecco, Legnago, Livorno, Lucca, Macerata, Mantua, Massa, Meldola, Messina, Milan, Mirano, Misterbianco, Modena, Monopoli, Monserrato, Montichiari, Monza, Naples, Negrar di Valpolicella, Novara, Orbassano, Padua, Palermo, Parma, Pavia, Perugia, Pesaro, Pescara, Peschiera del Garda, Piacenza, Pietra Ligure, Pisa, Pistoia, Ponderano, Ponte San Pietro, Pordenone, Pozzilli, Pozzuoli, Prato, Ranica, Ravenna, Reggio Calabria, Reggio Emilia, Rho, Rimini, Rionero in Vulture, Rivoli, Rome, Rozzano, Salerno, San Donato Milanese, San Giovanni Rotondo, Sassari, Siena, Sondrio, Statte, Telese Terme, Terni, Torrette, Tradate, Trento, Treviglio, Treviso, Tricase, Trieste, Turin, Udine, Varese, Venice, Vercelli, Verduno, Verona, Vicenza, Viterbo.

      France: Aix-en-Provence, Amiens, Angers, Annecy, Annonay, Antony, Argenteuil, Ars-Laquenexy, Aurillac, Avignon, Bayonne, Beauvais, Besançon, Bobigny, Bois-Guillaume, Bondy, Bordeaux, Boulogne-Billancourt, Boulogne-sur-Mer, Bourg-en-Bresse, Brest, Bron, Caen, Cahors, Caluire-et-Cuire, Cannes, Chambéry, Chambray-lès-Tours, Cholet, Clamart, Clermont-Ferrand, Clichy, Colmar, Colombes, Compiègne, Corbeil-Essonnes, Creil, Créteil, Dax, Dijon, Douai, Dunkirk, Épagny-Metz-Tessy, Garches, Gières, Gonesse, Grenoble, Hyères, La Roche-sur-Yon, La Rochelle, La Tronche, Laquenexy, Le Chesnay, Le Coudray, Le Havre, Le Kremlin-Bicêtre, Le Mans, Le Plessis-Robinson, Le Puy-en-Velay, Libourne, Lille, Limoges, Loos, Lorient, Lyon, Marseille, Martigues, Maubeuge, Meaux, Mont-de-Marsan, Montauban, Montfermeil, Montivilliers, Montpellier, Morlaix, Mougins, Mulhouse, Nancy, Nantes, Neuilly-sur-Seine, Nice, Nîmes, Orléans, Oullins-Pierre-Bénite, Paris, Pau, Perpignan, Pessac, Pierre-Bénite, Plérin, Poissy, Poitiers, Pontoise, Pringy, Quimper, Quint-Fonsegrives, Reims, Rennes, Rodez, Romans-sur-Isère, Roubaix, Rouen, Saint-Brieuc, Saint-Cloud, Saint-Denis, Saint-Étienne, Saint-Grégoire, Saint-Herblain, Saint-Malo, Saint-Mandé, Saint-Ouen-sur-Seine, Saint-Pierre, Saint-Priest-en-Jarez, Saint-Quentin, Salouël, Strasbourg, Suresnes, Toulon, Toulouse, Tours, Trévenans, Vaillant, Val-de-Marne, Valence, Valenciennes, Vannes, Vantoux, Villefranche-sur-Saône, Villejuif, Villeurbanne.

      Portugal: Alcabideche, Almada, Amadora, Aveiro, Braga, Carnaxide, Cascais, Coimbra, Covilhã, Creixomil e Mariz, Faro, Figueira da Foz, Funchal, Guarda, Guimarães, Leiria, Lisbon, Loures, Matosinhos, Paço de Arcos, Ponte De Lima, Portimão, Porto, Porto Covo, Santa Maria da Feira, Senhora da Hora, Setúbal, Torres Novas, Torres Vedras, Viana do Castelo, Vila Nova de Gaia, Vila Nova de Gaia, Vila Real.

      Norway: Ålesund, Bærum, Bergen, Bodø, Drammen, Fredrikstad, Gjøvik, Kalnes, Kristiansand, Lørenskog, Moss, Oslo, Sarpsborg, Skedsmokorset, Stavanger, Tønsberg, Tromsø, Trondheim.

      Greece: Alexandroupolis, Athens, Chaidari, Chortiatis, Corfu, Efkarpia, Exochi, Goudi, Haidari, Heraklion, Holargos, Ioannina, Kallithea, Larissa, Marousi, Mytilene, Nea Ionia, Patras, Piraeus, Pylaia-Chortiatis, Rio, Thessaloniki, Volos.

      Romania: Arad, Bacău, Baia Mare, Bragadiru, Brăila, Brașov, Bucharest, Buzău, Câmpulung, Caracal, Cluj-Napoca, Constanța, Craiova, Deva, Florești, Galați, Hunedoara, Iași, Mangalia, Oradea, Otopeni, Ovidiu, Pitești, Ploiești, Reșca, Sângeorgiu de Mureș, Satu Mare, Sibiu, Suceava, Târgu Mureș, Timișoara.

      Austria: Bad Dürrnberg, Bad Ischl, Bludenz, Braunau am Inn, Bregenz, Eisenstadt, Feldbach, Feldkirch, Graz, Grieskirchen, Innsbruck, Klagenfurt am Wörthersee, Krems an der Donau, Kufstein, Leoben, Linz, Multiple Locations, Rankweil, Salzburg, Sankt Pölten, Sankt Veit an der Glan, Schwaz, Steyr, Stockerau, Vienna, Vöcklabruck, Wals-Siezenheim, Wels, Wiener Neustadt, Zams.

      Hungary: Baja, Balassagyarmat, Balatonfüred, Békéscsaba, Budapest, Csorna, Debrecen, Deszk, Edelény, Eger, Encs, Farkasgyepű, Gödöllő, Gyöngyös, Gyöngyössolymos, Győr, Gyula, Hajdúnánás, Hatvan, Kaposvár, Kistarcsa, Komárom, Mátraháza, Miskolc, Monor, Mosonmagyaróvár, Nyíregyháza, Orosháza, Pécs, Püspökladány, Salgótarján, Sellye, Százhalombatta, Szeged, Székesfehérvár, Szekszárd, Szigetvár, Szolnok, Szombathely, Tatabánya, Törökbálint, Vác, Veszprém, Zalaegerszeg.

      Slovakia: Banská Bystrica, Bardejov, Bojnice, Bratislava, Brezno, Dubnica nad Váhom, Kežmarok, Kláštor pod Znievom, Košice, Levice, Liptovský Mikuláš, Lučenec, Malacky, Martin, Michalovce, Moldava nad Bodvou, Námestovo, Nitra, Nové Zámky, Partizánske, Piešťany, Poprad, Púchov, Rimavská Sobota, Rožňava, Ružomberok, Sabinov, Spišská Nová Ves, Šurany, Svidník, Topoľčany, Trebišov, Trenčín, Trnava, Žilina, Zvolen.

      Poland: Będzin, Bełchatów, Biała Podlaska, Białystok, Bielsko-Biała, Brzozów, Bydgoszcz, Bystra, Bytom, Chęciny, Chełm, Chojnice, Chorzów, Chrzanów, Częstochowa, Dąbrowa Górnicza, Elbląg, Gdańsk, Gdynia, Giżycko, Gliwice, Grodzisk Mazowiecki, Grudziądz, Gryfice, Grzepnica, Inowrocław, Iwonicz-Zdrój, Jelenia Góra, Józefów, Karczew, Katowice, Kędzierzyn Koźle, Kielce, Kłodzko, Knurów, Kobylniki, Konin, Kościan, Koszalin, Ksawerów, Łańcut, Łęczna, Legnica, Leszno, Łódź, Łowicz, Lubin, Lublin, Malbork, Mikołów, Mysłowice, Nadarzyn, Nowa Sól, Nowy Sącz, Nowy Targ, Olsztyn, Opole, Osielsko, Ossy, Ostróda, Ostrowiec Świętokrzyski, Oświęcim, Otwock, Piaseczno, Piła, Piotrków Trybunalski, Poland, Poznań, Prabuty, Przemyśl, Puławy, Racibórz, Radom, Rybnik, Rzeszów, Siedlce, Skarżysko-Kamienna, Skawina, Skierniewice, Skórzewo, Słupsk, Sochaczew, Sopot, Sosnowiec, Środa Wielkopolska, Staszów, Strzelce Opolskie, Świdnica, Szczecin, Szklarska Poręba, Sztum, Tarnów, Tarnowskie Góry, Toruń, Trzebnica, Tychy, Ustroń, Wadowice, Wałbrzych, Warsaw, Wejherowo, Wieliszew, Włocławek, Wrocław, Zabrze, Zamość, Zawadzkie, Zgierz, Żory.

      Czechia: Benešov, Beroun, Bílina, Bílovec, Boskovice, Brandýs nad Labem-Stará Boleslav, Brno, Broumov, České Budějovice, Choceň, Chomutov, Havířov, Havlíčkův Brod, Holešov, Hořovice, Hradec Králové, Jablonec nad Nisou, Jihlava, Jílové u Prahy, Jindřichův Hradec, Klatovy, Klecany, Kolín, Krnov, Kroměříž, Kutná Hora, Kyjov, Liberec, Litovel, Louny, Lovosice, Měšice, Miroslav, Mladá Boleslav, Náchod, Nové Město, Novu00e1 Ves Pod Pleu0161u00ed, Nový Bor, Nový Jičín, Olomouc, Opava, Ostrava, Pardubice, Pilsen, Písek, Polička, Prague, Příbram, Prostějov, Rokycany, Slaný, Slezská Ostrav, Strakonice, Svitavy, Teplice, Trinec, Trutnov, Ústí nad Labem, Varnsdorf, Vsetín, Zlín.

      Bulgaria: Blagoevgrad, Botevgrad, Branipole, Burgas, Cherven Bryag, Dimitrovgrad, Dobrich, Dupnitsa, Gabrovo, Gorna Oryahovitsa, Haskovo, Kardzhali, Kozloduy, Lovech, Montana, Panagyurishte, Pazardzhik, Pernik, Petrich, Pleven, Plovdiv, Razgrad, Ruse, Sevlievo, Shumen, Silistra, Sliven, Smolyan, Sofia, Stara Zagora, Troyan, Tsarev Brod, Varna, Veliko Tarnovo, Velingrad, Vidin, Vratsa.

      Sweden: Borås, Botkyrka, Danderyd, Eskilstuna, Falun, Gävle, Gothenburg, Halmstad, Helsingborg, Huddinge, Jönköping, Kalmar, Karlstad, Kristianstad, Lidingö, Linköping, Luleå, Lund, Malmö, Mölndal, Mölnlycke, Motala, Örebro, Östersund, Rättvik, Skövde, Solna, Stockholm, Sundsvall, Trollhättan, Umeå, Uppsala, Varberg, Växjö.

      Slovenia: Celje, Golnik, Jesenice, Kamnik, Ljubljana.

      Albania: Durrës, Elbasan, Korçë, Tirana.

      Finland: Espoo, Hämeenlinna, Helsinki, Järvenpää, Kokkola, Kuopio, Lahti, Oulu, Pori, Seinäjoki, Tampere, Turku, Vaasa.


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      The steps a patient needs to take in this clinical trial include:

      1. Receiving treatment in the allocated arm for eight cycles.
      2. Patients with HR-positive breast cancer will also receive endocrine-based therapy, which can include the use of CDK4/6 inhibitors. The therapy will be administered according to local guidelines, and the start of this therapy will be at the discretion of the investigator.

      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have one of the following diseases:

      1. Histologically confirmed unilateral or bilateral primary invasive carcinoma of the breast.
      2. Centrally confirmed HER2-negative breast cancer (IHC score 0-1 or FISH negative according to ASCO/CAP guideline).

      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Inclusion Criteria for the Study:

      1. Written Informed Consent: Each participant must provide written informed consent before beginning the study procedures. This consent must be documented according to local regulatory requirements, and participants should agree to follow the treatment and scheduled follow-up.
      2. Minimum Age: Participants must be at least 18 years old at the time of diagnosis.
      3. Tissue Provision: Willingness and ability to provide archived formalin fixed paraffin embedded (FFPE) tissue blocks for centralized verification of various biomarkers such as hormone receptor (HR) status, HER2 status, and Ki-67 (a proliferation marker), as well as tumor-infiltrating lymphocytes (TILs).
      4. Confirmed Diagnosis: Histologically confirmed unilateral or bilateral primary invasive carcinoma of the breast, identified through a core biopsy.
      5. HER2-negative Status: Centrally confirmed HER2-negative status as per standardized guidelines and either hormone receptor (HR)-positive (≥1% positive stained cells) or HR-negative (<1% positive stained cells).
      6. Residual Invasive Disease After Chemotherapy: High risk of recurrence based on the presence of any residual invasive disease or a score on the CPS+EG scale (a prognosis and treatment response tool combining clinical-pathological staging with estrogen-receptor status and grade).
      7. Surgical Treatment: Adequate surgery including resection of all clinically evident disease and ipsilateral axillary lymph node dissection is required.
      8. Neoadjuvant Chemotherapy: Completion of at least 16 weeks of neoadjuvant taxane-based chemotherapy, including at least 6 weeks of a taxane.
      9. No Evidence of Relapse: No clinical evidence for locoregional or distant relapse during or after preoperative chemotherapy.
      10. Exclusion of Metastases: If there was local progression during chemotherapy, distant metastases must be ruled out prior to study entry.
      11. Immune Therapy: Use of immune checkpoint inhibitors or immunotherapy during (neo)adjuvant therapy is allowed until completion of radiotherapy.
      12. gBRCA1/2 Mutation: Patients with known gBRCA1/2 mutations can participate unless they require adjuvant olaparib therapy.
      13. Post-surgery Interval: Less than 16 weeks from final surgery or less than 10 weeks from completing radiotherapy (whichever is later) until randomization.
      14. Completed Radiotherapy: Required radiotherapy should be delivered before the start of study treatment.
      15. Performance Status: An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which measures the patient’s level of functioning.
      16. Acute Toxicity Resolution: All acute toxic effects of prior treatments should be resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 grade ≤ 1 (excluding alopecia).
      17. Estimated Life Expectancy: At least 5 years, not accounting for the diagnosis of breast cancer.
      18. Accessibility for Follow-up: Must be available for scheduled visits, treatments, and follow-up.
      19. Cardiac Function: Normal cardiac function post-chemotherapy, with left ventricular ejection fraction (LVEF) above the institution’s normal limit.
      20. Laboratory Requirements: Specific hematological, hepatic, and renal function parameters must be met.
      21. Negative Pregnancy Test: Required for all women of childbearing potential within 14 days prior to randomization.
      22. Abstinence or Contraception: For individuals of childbearing potential, they must agree to either abstinent or use effective contraceptive methods.

      To help you understand some of the medical terms in the conditions:
      HR status and HER2 status: Indicators of hormone receptor presence and a protein called human epidermal growth factor receptor 2 on breast cancer cells, respectively, which guide treatment options.
      Ki-67: A protein that indicates cell proliferation; its presence in cancer cells suggests rapid growth.
      CPS+EG score: A scoring system that incorporates clinical and pathological stage, ER status, and grade of tumors to help predict treatment response and outcomes.
      ECOG performance status: A scale to assess how a disease affects a patient’s daily living abilities; scores range from 0 (fully active) to 5 (dead).
      NCI CTCAE: National Cancer Institute Common Terminology Criteria for Adverse Events; a standard to classify the severity of adverse effects of treatment.
      LVEF: Left ventricular ejection fraction; a measure of the percentage of blood leaving the heart each time it contracts, indicating heart function.
      ANC: Absolute neutrophil count; a measure of immune cell levels important for combating infection.

      What Reasons Could Exclude Me from the Study?

      Here is a list of conditions under which you cannot take part in the study, along with explanations of medical terms:

      1. Known hypersensitivity to any of the study drugs or their excipients: This means if you have had allergic reactions to any of the medications being used in the trial or their inactive components, you cannot participate.
      2. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or active pneumonitis on chest CT scan: These are types of lung diseases. ‘Idiopathic’ means the cause is unknown. ‘Pulmonary fibrosis’ is scarring in the lungs. ‘Organizing pneumonia’ is inflammation and scarring of the lung’s airways and air sacs. ‘Pneumonitis’ means inflammation of lung tissue.
      3. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving chemotherapy: Live vaccines are made from a weakened form of the germ. You need to avoid them one month before and after entering the trial or having chemotherapy because these vaccines may not be safe in patients with weakened immune systems.
      4. History of significant neurological or psychiatric disorders including psychotic disorders, dementia, or seizures that would prohibit the understanding and giving of informed consent: The trial requires that you can understand and consent to participate. Conditions like severe mental illness, memory loss, or seizures that affect your ability to give consent mean you cannot participate.
      5. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results: This is a general exclusion for any health issue that might affect how the treatment is evaluated or how the results are interpreted in terms of safety or effectiveness.
      6. Known allergic reactions to irinotecan: Irinotecan is a chemotherapy drug. If you are allergic to it, you cannot participate.
      7. Concurrent treatment with chronic corticosteroids prior to study entry except for certain forms and doses: Corticosteroids are anti-inflammatory drugs. If you are taking these persistently and in higher than allowed doses (more than 10 mg/day of prednisone or its equivalent), you might be excluded, unless they are in forms that are not systemic, like nasal or inhaled corticosteroids.

      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      Here is a list of the drugs involved in the study, along with a brief description of each active substance:

      1. Sacituzumab govitecan (Trodelvy): An antibody-drug conjugate used in cancer therapy. It targets Trop-2, a cell surface glycoprotein expressed in many epithelial cancers, and delivers the cytotoxic agent SN-38, the active metabolite of irinotecan, directly to cancer cells.
      2. Capecitabine (Xeloda): An orally-administered chemotherapeutic agent used to treat breast, gastric, and colorectal cancers. It is a prodrug that is enzymatically converted to 5-fluorouracil (5-FU) in the body, where it acts as an antimetabolite and thymidylate synthase inhibitor, interfering with DNA synthesis.
      3. Carboplatin (Paraplatin): A platinum-based chemotherapy drug used to treat various types of cancer. It forms platinum-DNA adducts, which cause apoptosis and cell death by interfering with DNA repair and replication.
      4. Cisplatin (Platinol): Another platinum-based chemotherapeutic agent that functions similarly to carboplatin, forming platinum-DNA adducts that lead to cell death. It is used to treat various forms of cancer, including testicular, ovarian, bladder, and lung cancers.

      These medications are used in different arms of the clinical trial, with dose and administration schedule tailored to the study’s protocol.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The clinical trial compares the safety and efficacy of the active substance sacituzumab govitecan with the treatment of physician’s choice, which could include known medications or treatments. Here are the details of the active substance used in the clinical trial:

      1. Sacituzumab Govitecan: An antibody-drug conjugate that targets TROP-2, a cell surface antigen expressed in many epithelial cancers, including triple-negative breast cancer (TNBC). It is known to medicine and referenced in medical literature. It combines a TROP-2-targeting antibody with a potent chemotherapy drug using a linker. This substance is designed to deliver the chemotherapy directly to cancer cells by binding to TROP-2.

      As for the treatments being compared against, these are chosen based on the physician’s choice, and could comprise other standard and known therapies or treatments that are part of medical practice. The trial’s main goal is to assess the safety profile of sacituzumab govitecan in comparison to the treatment of physician’s choice by monitoring the frequency and severity of adverse events.


      Study ID

      CT-EU-00025048

      Recruitment status

      Recruting new patients

      Start of the trial

      4 years ago

      Study phase

      Phase
      III

      Diseases