AzTrials
AzTrials

HER2-negative Breast CancerPhase 3SASCIANCT04595565

Sacituzumab Govitecan in Primary HER2-negative Breast Cancer

A Phase 3 study testing Capecitabine, Carboplatin and Cisplatin in people with HER2-negative Breast Cancer and Triple Negative Breast Cancer, run by GBG Forschungs GmbH at 163 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Phase III, prospective, multi-center, randomized, open label, parallel group, study in patients with HER2-negative breast cancer with residual disease after neoadjuvant chemotherapy with 1:1 allocation to: Arm A: Sacituzumab govitecan (days 1, 8 q3w for eight cycles); Arm B: treatment of physician´s choice (TPC… Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
Capecitabine, Carboplatin and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,332 participants
Where
163 sitesin 7 countries
Study dates
28 Oct 2020to 30 Mar 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.
  • Age at diagnosis at least 18 years.
  • Willingness and ability to provide archived formalin fixed paraffin embedded tissue (FFPE) block from surgery after neoadjuvant chemotherapy and from core biopsy before start of neoadjuvant chemotherapy, which will be used for centralized prospective confirmation of HR status, HER2 status, Ki-67 and tumor-infiltrating lymphocytes (TILs) and for retrospective exploratory correlation between genes, proteins, and mRNAs relevant to sensitivity/resistance to the investigational agents. For patients with bilateral carcinoma, FFPE blocks from both sides have to be provided for central testing.
  • Histologically confirmed unilateral or bilateral primary invasive carcinoma of the breast, confirmed histologically by core biopsy. The lead tumor has to be defined by the investigator based on the inclusion criteria for the respective subtype and on the risk status.
  • Centrally confirmed HER2-negative (IHC score 0-1 or FISH negative according to ASCO/CAP guideline) and either
  • HR-positive (≥1% positive stained cells) disease or
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  • HR-negative (<1% positive stained cells) assessed preferably on tissue from postneoadjuvant residual invasive disease of the breast, or if not possible, of residual nodal invasion. If not evaluable, core of diagnostic biopsy will be used. In case of bilateral breast cancer, HER2-negative status has to be confirmed for both sides.
  • Patients with residual invasive disease after neoadjuvant chemotherapy at high risk of recurrence defined by either:
  • For HR-negative: any residual invasive disease > ypT1mi and/or ypN1>1mm
  • For HR-positive disease: a CPS+EG score ≥ 3 or CPS+EG score 2 and ypN+ using local ER and grade assessed on core biopsies taken before start of neoadjuvant treatment.
  • Adequate surgical treatment including resection of clinically evident disease and ipsilateral axillary lymph node dissection. SNB before NACT is discouraged. Axillary dissection before NACT is not permitted. Axillary dissection, including Targeted Axillary Dissection (TAD) should be performed according to guidelines. Histologic complete resection (R0) of all invasive and in situ tumors is required.
  • Patients must have received neoadjuvant taxane-based chemotherapy for 16 weeks (anthracyclines are permitted). This period must include 6 weeks of a taxane containing neoadjuvant chemotherapy (exception: for patients with progressive disease that occurred after at least 6 weeks of taxane-containing neoadjuvant chemotherapy, a total treatment period of less than 16 weeks is also eligible).
  • No clinical evidence for locoregional or distant relapse during or after preoperative chemotherapy. Local progression during chemotherapy is not an exclusion criterion if adequate local control could be obtained.
  • In case of local progression during neoadjuvant therapy, distant metastases must be excluded by adequate imaging (CT/MRI recommend) prior to entering the trial.
  • Immune checkpoint inhibitor / immunotherapy during (neo)adjuvant therapy is allowed until the completion of radiotherapy.
  • Patients with known gBRCA1/2 mutation without indication to adjuvant olaparib therapy are allowed to participate in the trial.
  • An interval of less than 16 weeks since the date of final surgery or less than 10 weeks from completing radiotherapy (whichever occurs last) and the date of randomization is required.
  • Radiotherapy should be delivered before the start of study treatment. Radiotherapy to the breast is indicated in all patients with breast conserving surgery and to the chest wall and lymph nodes according to local guidelines as well as in all patients with cT3/4 or ypN+ disease treated by mastectomy.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedure or radiotherapy to NCI CTCAE v 5.0 grade ≤ 1 (except alopecia or other toxicities not considered a safety risk for the patients at the investigator´s discretion).
  • Estimated life expectancy of at least 5 years irrespective of the diagnosis of breast cancer.
  • The patient must be accessible for scheduled visits, treatment and follow-up.
  • Normal cardiac function after neoadjuvant chemotherapy must be confirmed according to local guidelines. Results for LVEF must be above the normal limit of the institution.
  • Laboratory requirements:
  • Hematology
  • Absolute neutrophil count (ANC) ≥1.5 x 109 / L
  • Platelets ≥100 x 109 / L
  • Hemoglobin ≥10 g/dL (≥6.2 mmol/L) Hepatic function
  • Total bilirubin <1.25x UNL
  • AST and ALT ≤1.5x UNL
  • Alkaline phosphatase ≤2.5x UNL Renal Function
  • <1.25x ULN creatinine or creatinine clearance ≥30 ml/min (according to Cockroft-Gault, if creatinine is above UNL).
  • Negative pregnancy test (urine or serum) within 14 days prior to randomization for all women of childbearing potential. A woman is considered to be of childbearing potential if she is not postmenopausal. Postmenopausal is defined as:
  • Age ≥60 years
  • Age <60 years and ≥12 continuous months of amenorrhea with no identified cause other than menopause
  • Surgical sterilization (bilateral oophorectomy and/or hysterectomy).
  • For women of childbearing potential and males with partners of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of sacituzumab govitecan for female patients and for at least 3 months for male patients; for at least 6 months after the last dose of capecitabine or carboplatin/cisplatin for female patients and for at least 3 months after the last dose of capecitabine or 6 months after the last dose of carboplatin/cisplatin for male patients. Examples of non-hormonal contraceptive methods with a failure rate of < 1% per year include: bilateral tubal ligation; male partner sterilization; intrauterine devices.
  • Complete staging work-up prior to the initiation of neoadjuvant chemotherapy. Missing staging investigations must be performed prior to randomization.

Who cannot join

  • Known hypersensitivity reaction to one of the compounds or substances used in this protocol.
  • Patients with definitive clinical or radiologic evidence of stage IV cancer (metastatic disease) are not eligible.
  • Patients with known gBRCA1/2 mutation and indicated or planned adjuvant olaparib therapy if available.
  • Patients with a history of any malignancy are ineligible with the following exceptions:
  • Patient has been disease-free for at least 5 years and is at low risk for recurrence of that malignancy
  • CIS of the cervix, basal cell and squamous cell carcinomas of the skin.
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  • Female patients: pregnancy or lactation at the time of randomization or intention to become pregnant during the study and up to 6 months after sacituzumab govitecan and up to 6 months after treatment with capecitabine or carboplatin/cisplatin.
  • Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study, including Gilbert´s disease, Crigler-Najjar-Syndrome, known hepatitis B, hepatitis C, known HIV positivity or known autoimmune disease other than diabetes, vitiligo, or stable thyroid disease, vitiligo, or other autoimmune skin disease with dermatologic manifestations only are permitted provided all of the following conditions are met:
  • Rash must cover < 10% of body surface area
  • Disease is well controlled at baseline and requires only low-potency topical corticosteroids
  • No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation (PUVA), methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.
  • Any condition that interferes with the safe administration of the treatment of physician´s choice in case the patient is randomized into the TPC arm.
  • Known or suspected congestive heart failure (>NYHA I) and/or coronary heart disease, angina pectoris requiring antianginal medication, previous history of myocardial infarction, evidence of prior infarction on ECG, uncontrolled or poorly controlled arterial hypertension (i.e. BP >150/90 mmHg under treatment with at maximum three antihypertensive drugs), rhythm abnormalities requiring permanent treatment (excluding chronic atrial fibrillation not requiring a pacemaker), clinically significant valvular heart disease, supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;conduction abnormality requiring a pacemaker.
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis or active pneumonitis on chest CT scan.
  • Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving chemotherapy.
  • History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
  • Known allergic reactions to irinotecan.
  • Concurrent treatment with:
  • Chronic corticosteroids prior to study entry with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or equivalent corticosteroid.

Trial locations and contacts

163 sites in 7 countries.

163 sites in 7 countries

Germany72 sites

  • Universitätsklinikum Aachen

    Aachen, North Rhine-Westphalia, 52074

  • Gemeinschaftspraxis Dres. Heinrich / Bangerter

    Augsburg, Bavaria, 86150

  • Hämatologie-Onkologie im Zentrum MVZ GmbH

    Augsburg, 86150

  • Hochwaldkrankenhaus, Gesundheitszentrum Wetterau gGmbH

    Bad Nauheim, Hesse, 61231

  • Sozialstiftung Bamberg, Klinik am Bruderwald

    Bamberg, Bavaria, 96049

  • Charité Campus Mitte, BIH Charité Rahel Hirsch

    Berlin, Brandenburg, 10117

  • MediOnko-Institut GbR

    Berlin, State of Berlin, 10367

  • HELIOS Klinikum Berlin Buch

    Berlin, 13125

  • Onkologische Schwerpunktpraxis, Studiengesellschaft Onkologie Bielefeld GbR

    Bielefeld, Nordrhein-Wastfalen, 33604

  • Kreiskliniken Böblingen gGmbH

    Böblingen, Baden-Wurttemberg, 71032

  • Marienhospital Bottrop gGmbH

    Bottrop, North Rhine-Westphalia, 46236

  • Knappschaft Kliniken Marienhospital Bottrop GmbH, Klinik für Gynäkologie und Geburtshilfe

    Bottrop, 46236

  • Studien GbR Braunschweig

    Braunschweig, Lower Saxony, 38100

  • Hämato-Onkologie im Medicum

    Bremen, Free Hanseatic City of Bremen, 28209

  • St. Elisabeth-Krankenhaus, Brustzentrum Köln-Hohenlind

    Cologne, North Rhine-Westphalia, 50935

  • Kliniken der Stadt Köln

    Cologne, North Rhine-Westphalia, 51067

  • DONAUISAR Klinikum Deggendorf

    Deggendorf, 94469

  • St, Johannes Hospital

    Dortmund, North Rhine-Westphalia, 44137

  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

    Dresden, Saxony, 01307

  • Heinrich-Heine-Universität Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40225

  • Praxis Dr. B. Adhami

    Erkelenz, North Rhine-Westphalia, 41812

  • Universitätsklinik Erlangen

    Erlangen, Bavaria, 91054

  • Kliniken Essen-Mitte Evang. Huyssens-Stiftung/Knappschaft GmbH

    Essen, North Rhine-Westphalia, 45136

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45147

  • Klinikum Esslingen GmbH

    Esslingen am Neckar, Baden-Wurttemberg, 73730

  • Centrum für Hämatologie und Onkologie am Bethanien-Krankenhaus

    Frankfurt am Main, Hesse, 60389

  • AGAPLESION Markus Krankenhaus

    Frankfurt am Main, Hesse, 60431

  • Klinikum der J. W. Goethe Universität

    Frankfurt am Main, Hesse, 60590

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Schwerpunktpraxis der Gynäkologie und Onkologie

    Fürstenwalde, Brandenburg, 15517

  • MVZ II der Niels Stensen Kliniken

    Georgsmarienhütte, Lower Saxony, 49124

  • SRH Wald-Klinikum Gera gGmbH, Brustzentrum Ostthüringen

    Gera, Thuringia, 07548

  • Universitäsklinik Halle/Saale

    Halle, Saxony-Anhalt, 06120

  • Mammazentrum Hamburg

    Hamburg, Free and Hanseatic City of Hamburg, 20364

  • Klinikum Stadt Hanau

    Hanau, Hesse, 63450

  • DIAKOVERE Henriettenstift Gynäkologie

    Hanover, Lower Saxony, 30559

  • ViDia Christliche Kliniken Karlsruhe

    Karlsruhe, Baden-Wurttemberg, 76135

  • Elisabeth Krankenhaus

    Kassel, Hesse, 34117

  • Klinikum Kassel GmbH, Gynäkologische Ambulanz

    Kassel, Hesse, 34125

  • Praxisklinik für Hämatologie und Onkologie

    Koblenz, Rhineland-Palatinate, 56068

  • Klinikum Landshur GmbH

    Landshut, Bavaria, 84034

  • Uniklinikum, Klinik für Geburtshilfe und Gynäkologie

    Mainz, Rhineland-Palatinate, 55131

  • Universitätsklinikum Mannheim, Frauenklinik

    Mannheim, Baden-Wurttemberg, 68167

  • MVZ Hämatologie-Onkologie Mayen/Koblenz GmbH

    Mayen, Rhineland-Palatinate, 56729

  • Rotkreuzklinikum München

    München, 80634

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149

  • MVZ Nordhausen gGmbH im Südharz Krankenhaus

    Nordhausen, Thuringia, 99734

  • medius Kliniken gGmbH Nürtingen

    Nürtingen, Baden-Wurttemberg, 72622

  • Sana Klinikum Offenbach

    Offenbach, Hesse, 63069

  • Klinikum Oldenburg AöR

    Oldenburg, Lower Saxony, 26133

  • Klinikum Passau

    Passau, 94032

  • Klinikum Ernst von Bergmann gGmbH

    Potsdam, 14467

  • MVZ für Hämatologie und Onkologie Ravensburg GmbH

    Ravensburg, 88212

  • Oncologianova GmbH

    Recklinghausen, North Rhine-Westphalia, 45659

  • Klinikum am Steinenberg

    Reutlingen, Baden-Wurttemberg, 72764

  • Klinikum Obergöltzsch Rodewisch

    Rodewisch, Saxony, 08228

  • Klinikum Südstadt

    Rostock, Mecklenburg-Vorpommern, 18059

  • Caritasklinik St. Theresia

    Saarbrücken, Saarland, 66113

  • Onkologische Schwerpunkt- Praxis Speyer

    Speyer, Rhineland-Palatinate, 67346

  • MVZ in der Klinik Dr. Hancken

    Stade, Lower Saxony, 21680

  • Johanniter Krankenhaus Genthin-Stendal

    Stendal, Saxony-Anhalt, 39576

  • SRH Zentralklinikum Suhl

    Suhl, Thuringia, 98527

  • Kreiskrankenhaus Torgau

    Torgau, Saxony, 04860

  • MVZ InnMed-Filiale Traunstein

    Traunstein, Bavaria, 83278

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89075

  • Schwarzwald-Baar-Klinikum

    Villingen-Schwenningen, Baden-Wurttemberg, 78052

  • Schwarzwald-Baar-Klinikum

    Villingen-Schwenningen, 78052

  • Helios Klinik Wiesbaden

    Wiesbaden, Hesse, 65199

  • Gemeinschaftspraxis Dallacker / Eilers

    Wolfenbüttel, Lower Saxony, 38304

  • Klinikum Worms

    Worms, Rhineland-Palatinate, 67550

  • Helios Universitätsklinikum Wuppertal

    Wuppertal, North Rhine-Westphalia, 42283

  • Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

Spain43 sites

  • COMPLEJO HOSPITALARIO UNIVERSITARIO A CORUÑA-Hospital Teresa Herrera (CHUAC)

    A Coruña, 15009

  • Complejo Hospitalario Universitario de Albacete

    Albacete, 2006

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, 28922

  • Hospital Virgen de Los Lirios

    Alcoy, 03804

  • Hospital General Universitario de Alicante

    Alicante, 3010

  • Institut Catala D'oncologia

    Badalona, 08916

  • Hospital Universitario de Cruces

    Barakaldo, Bizkaia, 48903

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041

  • Hospital San Pedro de Alcántara

    Cáceres, 10003

  • Consorcio Hospitalario Provincial de Castellón

    Castellon, 12002

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada, 28942

  • Hospital Galdakao-Usansolo

    Galdakao, 48960

  • Hospital Universitario Clinico San Cecilio

    Granada, 18016

  • Complejo Hospitalario de Jaén

    Jaén, 23007

  • Hospital Universitario Severo Ochoa

    Leganés, 28911

  • Clinica Universidad de Navarra

    Madrid, 28027

  • Hospital Universitario Ramón Y Cajal

    Madrid, 28034

  • Hospital Universitario San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010

  • Consorci Sanitari Del Maresme

    Mataró, 08304

  • Hospital General Universitario Morales Meseguer

    Murcia, 3008

  • Hospital Clínico Universitario Virgen de La Arrixaca

    Murcia, 30120

  • Hospital Universitari Son Llátzer

    Palma de Mallorca, '07198

  • Hospital Universitari Son Espases

    Palma de Mallorca, 07120

  • Clinica Universidad de Navarra

    Pamplona, 31008

  • Hospital Universitario Quirónsalud Madrid

    Pozuelo de Alarcón, 28223

  • Hospital Universitari Sant Joan de Reus

    Reus, 43204

  • Parc Tauli Hospital Universitari

    Sabadell, 08208

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, 38320

  • Hospital Universitario Ntra.Sra. de Candelaria

    Santa Cruz de Tenerife, 38010

  • Complejo Hospitalario Universitario de Santiago (Chus)

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen de La Macarena

    Seville, 41009

  • Hospital Quirónsalud Sagrado Corazón

    Seville, 41013

  • University Hospital Virgen Del Rocio S.L.

    Seville, 41013

  • Hospital Iniversitario De Toledo

    Toledo, 45007

  • Fundación Instituto Valenciano de Oncología

    Valencia, 46009

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Consorci Hospital General Universitari de Valencia

    Valencia, 46014

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003

  • Hospital Universitario Araba-Txagorritxu

    Vitoria-Gasteiz, 01009

Other trials in Spain

France26 sites

  • Institut de cancérologie de l'ouest (Angers)

    Angers, 49055

  • Institut Sainte Catherine

    Avignon, 84918

  • Clinique Tivoli Ducos

    Bordeaux, 33000

  • Institut Bergonié

    Bordeaux, 33000

  • CH Fleyriat

    Bourg-en-Bresse, 1000

  • Centre François Baclesse

    Caen, 14000

  • Centre Jean Perrin 5

    Clermont-Ferrand, 63011

  • Centre Georges François Leclerc

    Dijon, 21000

  • Centre Oscar Lambret

    Lille, 59020

  • CHU de Limoges

    Limoges, 87042

  • Centre Leon Berard

    Lyon, 69373

  • Institut Paoli-Calmettes

    Marseille, 13009

  • Institut régional du Cancer de Montpellier - ICM Val d'Aurelle

    Montpellier, 34298

  • Hôpital privé du Confluent

    Nantes, 44277

  • Centre Antoine Lacassagne

    Nice, 6189

  • Institut Curie (Paris)

    Paris, 75005

  • Centre Hospitalier de Pau

    Pau, 64000

  • Hôpital Privé Des Côtes d'Armor- Centre CARIO-HPCA

    Plérin, 22190

  • Institut Godinot

    Reims, 51100

  • Centre Eugène Marquis

    Rennes, 35042

  • Centre Henri Becquerel

    Rouen, 76000

  • Gcs Rissa

    Sarcelles, 95200

  • Institut de Cancérologie Strasbourg Europe-ICANS

    Strasbourg, 67200

  • Institut Claudius Regaud IUCTO

    Toulouse, 31059

  • CHU Bretonneau

    Tours, 37044

  • Gustave Roussy Cancer Campus

    Villejuif, 94800

Other trials in France

Austria12 sites

  • MUG - Univ.-Klinik f. Frauenheilkunde u. Geburtshilfe Graz

    Graz, 8036

  • MUG - Univ.-Klinik f. Innere Medizin Graz

    Graz, 8036

  • MUI - Univ. Klinik f. Frauenheilkunde Innsbruck

    Innsbruck, 6020

  • Ordensklinikum Linz GmbH - BHS

    Linz, 4010

  • TumorZentrum Kepler Uniklinikum Linz

    Linz, 4020

  • LKH Salzburg - PMU

    Salzburg, 5020

  • Universitätsklinikum St. Pölten

    Sankt Pölten, 3100

  • MUW - AKH Wien

    Vienna, 1090

  • MUW - Med. Univ.-Klinik AKH Wien

    Vienna, 1090

  • Salzkammergut-Klinikum Vöcklabruck

    Vöcklabruck, 4840

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600

  • Landesklinikum Wr. Neustadt

    Wiener Neustadt, 2700

Other trials in Austria

Ireland6 sites

  • Cork University Hospital

    Cork, T12 DFK4

  • St Vincent's University Hospital

    Dublin, D04 T6F4

  • St James's Hospital

    Dublin, D08 NHY1

  • Beaumont Hospital

    Dublin, D09V2N0

  • University Hospital Limerick

    Limerick, V94 F858

  • University Hospital Waterford

    Waterford, X91 ER8E

Other trials in Ireland

Switzerland3 sites

  • Kantonsspital Graubünden

    Chur, 7000

  • Breast Center KSSG

    Sankt Gallen, 9007

  • Brust-Zentrum Zürich

    Zurich, 8008

Other trials in Switzerland

Belgium1 site

  • CHU UCL Namur/Site Sainte Elisabeth

    Namur, 5000

Other trials in Belgium

About this study

Official title: Phase III Postneoadjuvant Study Evaluating Sacituzumab Govitecan, an Antibody Drug Conjugate in Primary HER2-negative Breast Cancer Patients With High Relapse Risk After Standard Neoadjuvant Treatment - SASCIA

Phase III, prospective, multi-center, randomized, open label, parallel group, study in patients with HER2-negative breast cancer with residual disease after neoadjuvant chemotherapy with 1:1 allocation to:

  • Arm A: Sacituzumab govitecan (days 1, 8 q3w for eight cycles);
  • Arm B: treatment of physician´s choice (TPC, defined as capecitabine or platinum-based chemotherapy for eight cycles or observation.
Read more

Treatment in either arm will be given for eight cycles.

In patients with HR-positive breast cancer, endocrine-based therapy, which includes the use of CDK4/6 inhibitors, will be administered according to local guidelines. The start of endocrine therapy will be at the discretion of the investigator; however, it will be encouraged to start after surgery/radiotherapy in patients without additional cytotoxic agents.

Adjuvant pembrolizumab can be given until the completion of radiotherapy before randomization. Within the study the use of pembrolizumab in patients with TNBC who received pembrolizumab as neoadjuvant therapy is allowed as monotherapy in the TPC arm, according to the approval of pembrolizumab in this setting.

Read the detailed description

Neoadjuvant chemotherapy (NACT) allows monitoring of tumor response to treatment and a pathological complete response (pCR) is associated with superior survival. This association is strongest in the most aggressive subtype, i.e. in patients with triple-negative breast cancer (TNBC). Patients with TNBC not achieving a pCR have a 5-year event free survival rate of about 50%. The association between pCR and prognosis is less pronounced in HR-positive/HER2-negative patients. However, the CPS+EG scoring system for prognosis after neoadjuvant chemotherapy, taking into account clinical stage, post treatment pathological stage, estrogen receptor status and grade, leads to an improved estimate of prognosis allowing to select patients at high risk of relapse for post-neoadjuvant therapy. Patients with TNBC not achieving a pCR as well as those with HR-positive/HER2-negative tumors and a CPS+EG score of 3 or 2/ypN+ are at high risk of relapse, warranting additional experimental therapies after NACT.

There is proof of concept, that post-neoadjuvant therapy can significantly improve survival. First data was provided by the CREATE X trial, randomizing patients with residual tumor after neoadjuvant chemotherapy to either capecitabine or observation. CREATE X included HER2-negative patients and demonstrated a significant improvement in disease-free survival (DFS) and overall survival (OS) in the overall population, which was confined to the TNBC subgroup.

Recently, the randomized post-neoadjuvant phase III KATHERINE study demonstrated an improved invasive disease-free survival in HER2-positive patients without pCR after trastuzumab +/- pertuzumab treated postoperatively with T-DM1, an antibody-drug-conjugate compared to trastuzumab.

Sacituzumab govitecan has demonstrated unprecedented activity in heavily pretreated patients with metastatic triple-negative and HR-positive/HER2-negative breast cancer, even after prior immune-checkpoint inhibitors or CDK4/6 and mTOR inhibitors. Based on the results of the phase I/II study, sacituzumab govitecan was granted a breakthrough therapy designation for the treatment of patients with advanced or metastatic TNBC who have received at least two previous lines of treatment for metastatic disease. The efficacy of sacituzumab govitecan in advanced TNBC was confirmed in the phase III ASCENT trial. Based on this study, sacituzumab govitecan received regular approval. Additionally, the TROPiCS-02 study showed an improvement in progression-free survival and OS over single-agent chemotherapy and a manageable safety profile in patients with heavily pre-treated HR-positive/HER2-negative endocrine-resistant, unresectable locally advanced or metastatic BC.

Being tested
Capecitabine, Carboplatin, Cisplatin, Sacituzumab govitecan
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapecitabineDrug

    Also called Xeloda

    2000 mg/m² day 1-14 q21 day cycle for eight cycles

  • CarboplatinDrug

    Also called Paraplatin

    AUC 5 q3w or AUC 1.5 weekly for eight 3 weekly cycles

  • CisplatinDrug

    Also called Platinol

    25mg/m3 weekly or 75 mg/m3 q3w

  • Sacituzumab govitecanDrug

    Also called Trodelvy

    10 mg/kg body weight on days 1, 8 q3w

Study groups in NCT04595565
Study groupRoleWhat they receive
Sacituzumab govitecanExperimentalSacituzumab govitecan is administered intravenously 10 mg/kg body weight on days 1, 8 q3w for eight cycles.
Receives: Drug: Sacituzumab govitecan
Treatment of physician´s choiceOtherTPC, defined as capecitabine or platinum-based chemotherapy for eight cycles or Observation.
Receives: Drug: Capecitabine; Drug: Carboplatin; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Invasive disease free survival (iDFS) between patients treated with sacituzumab govitecan vs. treatment of physician's choice.

    iDFS is defined as time from randomization until first iDFS event: local invasive recurrence following mastectomy, local invasive recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral invasive breast cancer, second non-breast primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause. (according to Hudis (J Clin Oncol 2007) )

    There will be one interim analysis for efficacy after 2/3 of the events to allow for early stopping of the trial due to overwhelming efficacy.

    Measured: Assuming 3.25 years of recruitment with 12 months ramp-up and 42 patients per month at peak and 3 years of follow-up after the last patient in, 396 events will be needed and final analysis is expected 75 months after study start.

Secondary outcomes (13)

  1. To compare overall survival (OS) between patients treated with sacituzumab govitecan vs. treatment of physician's choice.

    OS is defined as the time from randomization until death from any cause.

    One interim analysis of the key secondary endpoint OS will be performed at the time of the final analysis of the iDFS.

    Measured: Assuming 3.25 years of recruitment 398 events will be needed with a power of 80% and final analysis is expected after 99 months (8.3 years after first patient in, 2 years after final analysis of iDFS).

  2. Distant disease-free survival (DDFS) between patients treated with sacituzumab govitecan vs. treatment of physician's choice.

    DDFS is defined as the time from randomization until distant recurrence of disease, second primary invasive cancer (non-breast, excluding squamous or basal cell carcinoma of the skin), and death due to any cause.

    Measured: DDFS will be analyzed at the time of the final iDFS analysis (is expected 75 months after study start)

  3. To compare the invasive breast cancer-free survival (iBCFS) between both groups.

    iBCFS is defined as the time from randomization until first iDFS event excluding any second non-breast primary cancer.

    Measured: iBCFS will be analyzed at the time of the final iDFS analysis (is expected 75 months after study start)

  4. Locoregional recurrences-free interval between patients treated with sacituzumab govitecan vs. treatment of physician's choice.

    LRRFI is defined as the time from randomization until any loco-regional (ipsilateral breast (invasive), chest wall, local/regional lymph nodes) recurrence of disease or any invasive contralateral breast cancer whichever occurs first. Distant recurrence, secondary malignancy and death are considered as competing risks and will be accounted for in the analysis.

    Measured: Time-to-Event Outcome Measure up to 75 month after study start.

  5. iDFS in stratified subgroups.

    HR-negative vs. HR-positive ypN+ vs. ypN0.

    Measured: Will be analyzed at the time of the final iDFS analysis (is expected 75 months after study start)

  6. OS in stratified subgroups.

    HR-negative vs. HR-positive ypN+ vs. ypN0.

    Measured: Will be analyzed after 99 months (8.3 years after first patient in, 2 years after final analysis of iDFS)

  7. iDFS in exploratory subgroups.

    Prior platinum therapy (TNBC)

    • Prior immune-checkpoint inhibitor therapy (TNBC)
    • Experimental arm vs. active TPC in TNBC, overall and in subgroups of different active TPC
    • low vs. high TROP2-expression

    Measured: Will be analyzed at the time of the final iDFS analysis (is expected 75 months after study start)

  8. OS in exploratory subgroups.

    Prior platinum therapy (TNBC)

    • Prior immune-checkpoint inhibitor therapy (TNBC)
    • Experimental arm vs. active TPC in TNBC, overall and in subgroups of different active TPC
    • low vs. high TROP2-expression

    Measured: Will be analyzed after 99 months (8.3 years after first patient in, 2 years after final analysis of iDFS)

  9. Safety - To compare safety between patients treated with sacituzumab govitecan vs. treatment of physician's choice.

    Frequency and severity of adverse events graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    One interim analysis for safety will be performed after first 50 patients completed 4 cycles of treatment.

    Measured: Final safety analysis will take place when interim analysis of the primary endpoint is performed (all patients will have completed treatment, estimated 54 months from study start)

  10. Compliance - To compare dose-density, dose reductions, dose delays, treatment interruptions and treatment discontinuation rates between patients treated with sacituzumab govitecan vs. treatment of physician's choice.

    Safety, tolerability, and treatment compliance: the number and percentage of patients whose treatment had to be reduced, delayed or permanently stopped will be summarized for each treatment arm, reasons for dose modification, delay and premature termination will be categorized according to the main reason and will be presented in frequency tables. Treatment arms will be compared regarding the occurrence of any adverse events (AE) (grade 1-5), low grade AE (grade 1-2), and high grade AE (grade 3-5) using Fisher's exact test. Those tests are descriptive in nature and no adjustments for multiple comparisons will be made.

    Measured: Analysis with final safety analysis expected 54 months after study start.

  11. Patient reported outcome: Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)

    For each treatment group and at each time point, the number and percentage of patients who completed the instrument will be summarized, as well as the reasons for non-completion of these questionnaires, if known.

    For each of the FACT-B scales (37 items; 5 point Likert-typ scale; scale from 0-148; the higher the score, the better the QOL) the results will be summarized using descriptive statistics for each treatment group at each time point. Results based on the observed values as well as changes from baseline (including both within group and between group differences) will be displayed.

    Measured: Through study completion and until 12 months after End of treatment of single patients.

  12. Patient reported outcome: Functional Assessment of Cancer Therapy - Cognitive function issues (FACT-Cog)

    For each treatment group and at each time point, the number and percentage of patients who completed the instrument will be summarized, as well as the reasons for non-completion of these questionnaires, if known.

    For each of the FACT-cog scales (37 items; 5 point Likert-type scale; scale from 0-126; the higher the score, the better the QOL) the results will be summarized using descriptive statistics for each treatment group at each time point. Results based on the observed values as well as changes from baseline (including both within group and between group differences) will be displayed.

    Measured: Through study completion and until 12 months after End of treatment of single patients.

  13. Patient reported outcome: Health Questionnaire 5-Level EQ-5D (EQ-5D-5L)

    For each treatment group and at each time point, the number and percentage of patients who completed the instrument will be summarized, as well as the reasons for non-completion of the questionnair, if known.

    For the EQ-5D-5L instrument (6 items; 5 times 5 point Likert-type scale; 1-digit number that expresses the level selected for the item; 1 visual analogue scale (0-100mm); the higher the score, the better the QOL) the results will be summarized using descriptive statistics for each treatment group at each time point. Results based on the observed values as well as changes from baseline (including both within group and between group differences) will be displayed.

    Measured: Through study completion and until 12 months after End of treatment of single patients.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2020
  2. Study start28 Oct 2020
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion30 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,332 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04595565
Sponsor's protocol ID
GBG102 - SASCIA
Acronym
SASCIA
Status last verified
Apr 2026
First submitted
7 Apr 2020
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Marmé F, Hanusch C, Furlanetto J, et al. Safety interim analysis (SIA) of the phase III postneoadjuvant SASCIA study evaluating sacituzumab govitecan (SG) in patients with primary HER2-negative breast cancer (BC) at high relapse risk after neoadjuvant treatment. ESMO Breast 2022; 58O, proffered paper presentation. https://doi.org/10.1016/j.annonc.2022.03.075

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Capecitabine, Carboplatin and Cisplatin in people with HER2-negative Breast Cancer and Triple Negative Breast Cancer, run by GBG Forschungs GmbH at 163 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 38 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 163 sites in Germany, Spain, France, Austria, Ireland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Invasive disease free survival (iDFS) between patients treated with sacituzumab govitecan vs. treatment of physician's choice. (time frame: Assuming 3.25 years of recruitment with 12 months ramp-up and 42 patients per month at peak and 3 years of follow-up after the last patient in, 396 events will be needed and final analysis is expected 75 months after study start.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04595565, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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