Sacituzumab Govitecan in Primary HER2-negative Breast Cancer

NCT ID: NCT04595565

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1332 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-28
• Study Completion Date: 2029-03-30

Brief 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, defined as capecitabine or platinum-based chemotherapy for eight cycles or observation.

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.

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.

Conditions

HER2-negative Breast Cancer; Triple Negative Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sacituzumab govitecan

Sacituzumab govitecan is administered intravenously 10 mg/kg body weight on days 1, 8 q3w for eight cycles.

Group Type: EXPERIMENTAL

Sacituzumab govitecan

Intervention Type: DRUG

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

Treatment of physician´s choice

TPC, defined as capecitabine or platinum-based chemotherapy for eight cycles or Observation.

Group Type: OTHER

Capecitabine

Intervention Type: DRUG

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

Carboplatin

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

25mg/m3 weekly or 75 mg/m3 q3w

Interventions

Capecitabine

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

Intervention Type: DRUG

Carboplatin

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

Intervention Type: DRUG

Cisplatin

25mg/m3 weekly or 75 mg/m3 q3w

Intervention Type: DRUG

Sacituzumab govitecan

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

Intervention Type: DRUG

Other Intervention Names

Xeloda; Paraplatin; Platinol; Trodelvy

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Age at diagnosis at least 18 years.

3. 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.

5. 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
• 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.

6. 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.

7. 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.

8. 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).

9. 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.

10. In case of local progression during neoadjuvant therapy, distant metastases must be excluded by adequate imaging (CT/MRI recommend) prior to entering the trial.

11. Immune checkpoint inhibitor / immunotherapy during (neo)adjuvant therapy is allowed until the completion of radiotherapy.

12. Patients with known gBRCA1/2 mutation without indication to adjuvant olaparib therapy are allowed to participate in the trial.

13. 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.

14. 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.

15. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

16. 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).

17. Estimated life expectancy of at least 5 years irrespective of the diagnosis of breast cancer.

18. The patient must be accessible for scheduled visits, treatment and follow-up.

19. 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.

20. 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).

21. 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).

22. 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.

23. Complete staging work-up prior to the initiation of neoadjuvant chemotherapy. Missing staging investigations must be performed prior to randomization.

Exclusion Criteria

1. Known hypersensitivity reaction to one of the compounds or substances used in this protocol.

2. Patients with definitive clinical or radiologic evidence of stage IV cancer (metastatic disease) are not eligible.

3. Patients with known gBRCA1/2 mutation and indicated or planned adjuvant olaparib therapy if available.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis or active pneumonitis on chest CT scan.

10. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving chemotherapy.

11. History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.

12. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.

13. Known allergic reactions to irinotecan.

14. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Austrian Breast & Colorectal Cancer Study Group

NETWORK

Sponsor Role: collaborator

Spanish Breast Cancer Research Group (GEICAM)

UNKNOWN

Sponsor Role: collaborator

ETOP IBCSG Partners Foundation

NETWORK

Sponsor Role: collaborator

Cancer Trials Ireland

NETWORK

Sponsor Role: collaborator

UNICANCER

OTHER

Sponsor Role: collaborator

GBG Forschungs GmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederik Marmé, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

ASCO, ESMO, GBG, AGO, DKG, DGS, DKG

Locations

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

Graz, , Austria

MUG - Univ.-Klinik f. Innere Medizin Graz

Graz, , Austria

MUI - Univ. Klinik f. Frauenheilkunde Innsbruck

Innsbruck, , Austria

Ordensklinikum Linz GmbH - BHS

Linz, , Austria

TumorZentrum Kepler Uniklinikum Linz

Linz, , Austria

LKH Salzburg - PMU

Salzburg, , Austria

Universitätsklinikum St. Pölten

Sankt Pölten, , Austria

MUW - AKH Wien

Vienna, , Austria

MUW - Med. Univ.-Klinik AKH Wien

Vienna, , Austria

Salzkammergut-Klinikum Vöcklabruck

Vöcklabruck, , Austria

Klinikum Wels-Grieskirchen GmbH

Wels, , Austria

Landesklinikum Wr. Neustadt

Wiener Neustadt, , Austria

CHU UCL Namur/Site Sainte Elisabeth

Namur, , Belgium

Institut de cancérologie de l'ouest (Angers)

Angers, , France

Institut Sainte Catherine

Avignon, , France

Clinique Tivoli Ducos

Bordeaux, , France

Institut Bergonié

Bordeaux, , France

CH Fleyriat

Bourg-en-Bresse, , France

Centre François Baclesse

Caen, , France

Centre Jean Perrin 5

Clermont-Ferrand, , France

Centre Georges François Leclerc

Dijon, , France

Centre Oscar Lambret

Lille, , France

CHU de Limoges

Limoges, , France

Centre Leon Berard

Lyon, , France

Institut Paoli-Calmettes

Marseille, , France

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

Montpellier, , France

Hôpital privé du Confluent

Nantes, , France

Centre Antoine Lacassagne

Nice, , France

Institut Curie (Paris)

Paris, , France

Centre Hospitalier de Pau

Pau, , France

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

Plérin, , France

Institut Godinot

Reims, , France

Centre Eugène Marquis

Rennes, , France

Centre Henri Becquerel

Rouen, , France

Gcs Rissa

Sarcelles, , France

Institut de Cancérologie Strasbourg Europe-ICANS

Strasbourg, , France

Institut Claudius Regaud IUCTO

Toulouse, , France

CHU Bretonneau

Tours, , France

Gustave Roussy Cancer Campus

Villejuif, , France

Kreiskliniken Böblingen gGmbH

Böblingen, Baden-Wurttemberg, Germany

Klinikum Esslingen GmbH

Esslingen am Neckar, Baden-Wurttemberg, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

ViDia Christliche Kliniken Karlsruhe

Karlsruhe, Baden-Wurttemberg, Germany

Universitätsklinikum Mannheim, Frauenklinik

Mannheim, Baden-Wurttemberg, Germany

medius Kliniken gGmbH Nürtingen

Nürtingen, Baden-Wurttemberg, Germany

Klinikum am Steinenberg

Reutlingen, Baden-Wurttemberg, Germany

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Schwarzwald-Baar-Klinikum

Villingen-Schwenningen, Baden-Wurttemberg, Germany

Gemeinschaftspraxis Dres. Heinrich / Bangerter

Augsburg, Bavaria, Germany

Sozialstiftung Bamberg, Klinik am Bruderwald

Bamberg, Bavaria, Germany

Universitätsklinik Erlangen

Erlangen, Bavaria, Germany

Klinikum Landshur GmbH

Landshut, Bavaria, Germany

Gemeinschaftspraxis Dr. U. Kronawitter/ Dr. C. Jung

Traunstein, Bavaria, Germany

Charité Campus Mitte, BIH Charité Rahel Hirsch

Berlin, Brandenburg, Germany

Schwerpunktpraxis der Gynäkologie und Onkologie

Fürstenwalde, Brandenburg, Germany

Hämato-Onkologie im Medicum

Bremen, City state Bremen, Germany

Mammazentrum Hamburg

Hamburg, Hamburg, Germany

Hochwaldkrankenhaus, Gesundheitszentrum Wetterau gGmbH

Bad Nauheim, Hesse, Germany

Centrum für Hämatologie und Onkologie am Bethanien-Krankenhaus

Frankfurt am Main, Hesse, Germany

AGAPLESION Markus Krankenhaus

Frankfurt am Main, Hesse, Germany

Klinikum der J. W. Goethe Universität

Frankfurt am Main, Hesse, Germany

Klinikum Stadt Hanau

Hanau, Hesse, Germany

Elisabeth Krankenhaus

Kassel, Hesse, Germany

Klinikum Kassel GmbH, Gynäkologische Ambulanz

Kassel, Hesse, Germany

Sana Klinikum Offenbach

Offenbach, Hesse, Germany

Helios Klinik Wiesbaden

Wiesbaden, Hesse, Germany

Studien GbR Braunschweig

Braunschweig, Lower Saxony, Germany

MVZ II der Niels Stensen Kliniken

Georgsmarienhütte, Lower Saxony, Germany

DIAKOVERE Henriettenstift Gynäkologie

Hanover, Lower Saxony, Germany

Klinikum Oldenburg AöR

Oldenburg, Lower Saxony, Germany

MVZ in der Klinik Dr. Hancken

Stade, Lower Saxony, Germany

Gemeinschaftspraxis Dallacker / Eilers

Wolfenbüttel, Lower Saxony, Germany

Klinikum Südstadt

Rostock, Mecklenburg-Vorpommern, Germany

Onkologische Schwerpunktpraxis, Studiengesellschaft Onkologie Bielefeld GbR

Bielefeld, Nordrhein-Wastfalen, Germany

Universitätsklinikum Aachen

Aachen, North Rhine-Westphalia, Germany

Marienhospital Bottrop gGmbH

Bottrop, North Rhine-Westphalia, Germany

St. Elisabeth-Krankenhaus, Brustzentrum Köln-Hohenlind

Cologne, North Rhine-Westphalia, Germany

Kliniken der Stadt Köln

Cologne, North Rhine-Westphalia, Germany

St, Johannes Hospital

Dortmund, North Rhine-Westphalia, Germany

Heinrich-Heine-Universität Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Praxis Dr. B. Adhami

Erkelenz, North Rhine-Westphalia, Germany

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

Essen, North Rhine-Westphalia, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany

Oncologianova GmbH

Recklinghausen, North Rhine-Westphalia, Germany

Helios Universitätsklinikum Wuppertal

Wuppertal, North Rhine-Westphalia, Germany

Praxisklinik für Hämatologie und Onkologie

Koblenz, Rhineland-Palatinate, Germany

Uniklinikum, Klinik für Geburtshilfe und Gynäkologie

Mainz, Rhineland-Palatinate, Germany

MVZ Hämatologie-Onkologie Mayen/Koblenz GmbH

Mayen, Rhineland-Palatinate, Germany

Onkologische Schwerpunkt- Praxis Speyer

Speyer, Rhineland-Palatinate, Germany

Klinikum Worms

Worms, Rhineland-Palatinate, Germany

Caritasklinik St. Theresia

Saarbrücken, Saarland, Germany

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Dresden, Saxony, Germany

Klinikum Obergöltzsch Rodewisch

Rodewisch, Saxony, Germany

Kreiskrankenhaus Torgau

Torgau, Saxony, Germany

Universitäsklinik Halle/Saale

Halle, Saxony-Anhalt, Germany

Johanniter Krankenhaus Genthin-Stendal

Stendal, Saxony-Anhalt, Germany

MediOnko-Institut GbR

Berlin, State of Berlin, Germany

SRH Wald-Klinikum Gera gGmbH, Brustzentrum Ostthüringen

Gera, Thuringia, Germany

MVZ Nordhausen gGmbH im Südharz Krankenhaus

Nordhausen, Thuringia, Germany

SRH Zentralklinikum Suhl

Suhl, Thuringia, Germany

Hämatologie-Onkologie im Zentrum MVZ GmbH

Augsburg, , Germany

HELIOS Klinikum Berlin Buch

Berlin, , Germany

Marienhospital Bottrop gGmbH

Bottrop, , Germany

DONAUISAR Klinikum Deggendorf

Deggendorf, , Germany

Rotkreuzklinikum München

München, , Germany

Klinikum Passau

Passau, , Germany

Klinikum Ernst von Bergmann gGmbH

Potsdam, , Germany

MVZ für Hämatologie und Onkologie Ravensburg GmbH

Ravensburg, , Germany

Schwarzwald-Baar-Klinikum

Villingen-Schwenningen, , Germany

Universitätsklinikum Würzburg

Würzburg, , Germany

Cork University Hospital

Cork, , Ireland

St Vincent's University Hospital

Dublin, , Ireland

St James's Hospital

Dublin, , Ireland

Beaumont Hospital

Dublin, , Ireland

University Hospital Limerick

Limerick, , Ireland

University Hospital Waterford

Waterford, , Ireland

Hospital Universitario de Cruces

Barakaldo, Bizkaia, Spain

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

A Coruña, , Spain

Complejo Hospitalario Universitario de Albacete

Albacete, , Spain

Hospital Universitario Fundación Alcorcón

Alcorcón, , Spain

Hospital Virgen de Los Lirios

Alcoy, , Spain

Hospital General Universitario de Alicante

Alicante, , Spain

Institut Catala D'oncologia

Badalona, , Spain

Hospital de La Santa Creu I Sant Pau

Barcelona, , Spain

Consorcio Hospitalario Provincial de Castellón

Castellon, , Spain

Hospital San Pedro de Alcántara

Cáceres, , Spain

Hospital Universitario de Fuenlabrada

Fuenlabrada, , Spain

Hospital Galdakao-Usansolo

Galdakao, , Spain

Hospital Universitario Clinico San Cecilio

Granada, , Spain

Complejo Hospitalario de Jaén

Jaén, , Spain

Hospital Universitario Severo Ochoa

Leganés, , Spain

Clinica Universidad de Navarra

Madrid, , Spain

Hospital Universitario Ramón Y Cajal

Madrid, , Spain

Hospital Universitario San Carlos

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Consorci Sanitari Del Maresme

Mataró, , Spain

Hospital Clinico Universitario Virgen de la Victoria

Málaga, , Spain

Hospital General Universitario Morales Meseguer

Murcia, , Spain

Hospital Clínico Universitario Virgen de La Arrixaca

Murcia, , Spain

Hospital Universitari Son Llátzer

Palma de Mallorca, , Spain

Hospital Universitari Son Espases

Palma de Mallorca, , Spain

Clinica Universidad de Navarra

Pamplona, , Spain

Hospital Universitario Quirónsalud Madrid

Pozuelo de Alarcón, , Spain

Hospital Universitari Sant Joan de Reus

Reus, , Spain

Parc Tauli Hospital Universitari

Sabadell, , Spain

Hospital Universitario de Salamanca

Salamanca, , Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, , Spain

Hospital Universitario Ntra.Sra. de Candelaria

Santa Cruz de Tenerife, , Spain

Complejo Hospitalario Universitario de Santiago (Chus)

Santiago de Compostela, , Spain

Hospital Universitario Virgen de La Macarena

Seville, , Spain

Hospital Quirónsalud Sagrado Corazón

Seville, , Spain

University Hospital Virgen Del Rocio S.L.

Seville, , Spain

Hospital Iniversitario De Toledo

Toledo, , Spain

Fundación Instituto Valenciano de Oncología

Valencia, , Spain

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Consorci Hospital General Universitari de Valencia

Valencia, , Spain

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Hospital Universitario Araba-Txagorritxu

Vitoria-Gasteiz, , Spain

Kantonsspital Graubünden

Chur, , Switzerland

Breast Center KSSG

Sankt Gallen, , Switzerland

Brust-Zentrum Zürich

Zurich, , Switzerland

Countries

Austria; Belgium; France; Germany; Ireland; Spain; Switzerland

References

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

Reference Type: RESULT

Related Links

https://www.gbg.de/en/trials/sascia.php

GBG website

Other Identifiers

GBG102 - SASCIA

Identifier Type: -

Identifier Source: org_study_id