Sacituzumab Govitecan in Primary HER2-negative Breast Cancer
SASCIA
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
1 other identifier
interventional
1,332
7 countries
163
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2020
Longer than P75 for phase_3
163 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2020
CompletedFirst Posted
Study publicly available on registry
October 20, 2020
CompletedStudy Start
First participant enrolled
October 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 30, 2029
April 22, 2026
April 1, 2026
6.4 years
April 7, 2020
April 17, 2026
Conditions
Outcome Measures
Primary Outcomes (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.
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)
To compare overall survival (OS) between patients treated with sacituzumab govitecan vs. treatment of physician's choice.
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).
Distant disease-free survival (DDFS) between patients treated with sacituzumab govitecan vs. treatment of physician's choice.
DDFS will be analyzed at the time of the final iDFS analysis (is expected 75 months after study start)
To compare the invasive breast cancer-free survival (iBCFS) between both groups.
iBCFS will be analyzed at the time of the final iDFS analysis (is expected 75 months after study start)
Locoregional recurrences-free interval between patients treated with sacituzumab govitecan vs. treatment of physician's choice.
Time-to-Event Outcome Measure up to 75 month after study start.
iDFS in stratified subgroups.
Will be analyzed at the time of the final iDFS analysis (is expected 75 months after study start)
- +8 more secondary outcomes
Study Arms (2)
Sacituzumab govitecan
EXPERIMENTALSacituzumab govitecan is administered intravenously 10 mg/kg body weight on days 1, 8 q3w for eight cycles.
Treatment of physician´s choice
OTHERTPC, defined as capecitabine or platinum-based chemotherapy for eight cycles or Observation.
Interventions
2000 mg/m² day 1-14 q21 day cycle for eight cycles
AUC 5 q3w or AUC 1.5 weekly for eight 3 weekly cycles
10 mg/kg body weight on days 1, 8 q3w
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- 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).
- 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.
- +21 more criteria
You may not qualify if:
- 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.
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GBG Forschungs GmbHlead
- Gilead Sciencescollaborator
- UNICANCERcollaborator
- Austrian Breast & Colorectal Cancer Study Groupcollaborator
- Spanish Breast Cancer Research Group (GEICAM)collaborator
- ETOP IBCSG Partners Foundationcollaborator
- Cancer Trials Irelandcollaborator
Study Sites (163)
MUG - Univ.-Klinik f. Frauenheilkunde u. Geburtshilfe Graz
Graz, 8036, Austria
MUG - Univ.-Klinik f. Innere Medizin Graz
Graz, 8036, Austria
MUI - Univ. Klinik f. Frauenheilkunde Innsbruck
Innsbruck, 6020, Austria
Ordensklinikum Linz GmbH - BHS
Linz, 4010, Austria
TumorZentrum Kepler Uniklinikum Linz
Linz, 4020, Austria
LKH Salzburg - PMU
Salzburg, 5020, Austria
Universitätsklinikum St. Pölten
Sankt Pölten, 3100, Austria
MUW - AKH Wien
Vienna, 1090, Austria
MUW - Med. Univ.-Klinik AKH Wien
Vienna, 1090, Austria
Salzkammergut-Klinikum Vöcklabruck
Vöcklabruck, 4840, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, 4600, Austria
Landesklinikum Wr. Neustadt
Wiener Neustadt, 2700, Austria
CHU UCL Namur/Site Sainte Elisabeth
Namur, 5000, Belgium
Institut de cancérologie de l'ouest (Angers)
Angers, 49055, France
Institut Sainte Catherine
Avignon, 84918, France
Clinique Tivoli Ducos
Bordeaux, 33000, France
Institut Bergonié
Bordeaux, 33000, France
CH Fleyriat
Bourg-en-Bresse, 1000, France
Centre François Baclesse
Caen, 14000, France
Centre Jean Perrin 5
Clermont-Ferrand, 63011, France
Centre Georges François Leclerc
Dijon, 21000, France
Centre Oscar Lambret
Lille, 59020, France
CHU de Limoges
Limoges, 87042, France
Centre Leon Berard
Lyon, 69373, France
Institut Paoli-Calmettes
Marseille, 13009, France
Institut régional du Cancer de Montpellier - ICM Val d'Aurelle
Montpellier, 34298, France
Hôpital privé du Confluent
Nantes, 44277, France
Centre Antoine Lacassagne
Nice, 6189, France
Institut Curie (Paris)
Paris, 75005, France
Centre Hospitalier de Pau
Pau, 64000, France
Hôpital Privé Des Côtes d'Armor- Centre CARIO-HPCA
Plérin, 22190, France
Institut Godinot
Reims, 51100, France
Centre Eugène Marquis
Rennes, 35042, France
Centre Henri Becquerel
Rouen, 76000, France
Gcs Rissa
Sarcelles, 95200, France
Institut de Cancérologie Strasbourg Europe-ICANS
Strasbourg, 67200, France
Institut Claudius Regaud IUCTO
Toulouse, 31059, France
CHU Bretonneau
Tours, 37044, France
Gustave Roussy Cancer Campus
Villejuif, 94800, France
Kreiskliniken Böblingen gGmbH
Böblingen, Baden-Wurttemberg, 71032, Germany
Klinikum Esslingen GmbH
Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
ViDia Christliche Kliniken Karlsruhe
Karlsruhe, Baden-Wurttemberg, 76135, Germany
Universitätsklinikum Mannheim, Frauenklinik
Mannheim, Baden-Wurttemberg, 68167, Germany
medius Kliniken gGmbH Nürtingen
Nürtingen, Baden-Wurttemberg, 72622, Germany
Klinikum am Steinenberg
Reutlingen, Baden-Wurttemberg, 72764, Germany
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, 89075, Germany
Schwarzwald-Baar-Klinikum
Villingen-Schwenningen, Baden-Wurttemberg, 78052, Germany
Gemeinschaftspraxis Dres. Heinrich / Bangerter
Augsburg, Bavaria, 86150, Germany
Sozialstiftung Bamberg, Klinik am Bruderwald
Bamberg, Bavaria, 96049, Germany
Universitätsklinik Erlangen
Erlangen, Bavaria, 91054, Germany
Klinikum Landshur GmbH
Landshut, Bavaria, 84034, Germany
MVZ InnMed-Filiale Traunstein
Traunstein, Bavaria, 83278, Germany
Charité Campus Mitte, BIH Charité Rahel Hirsch
Berlin, Brandenburg, 10117, Germany
Schwerpunktpraxis der Gynäkologie und Onkologie
Fürstenwalde, Brandenburg, 15517, Germany
Mammazentrum Hamburg
Hamburg, Free and Hanseatic City of Hamburg, 20364, Germany
Hämato-Onkologie im Medicum
Bremen, Free Hanseatic City of Bremen, 28209, Germany
Hochwaldkrankenhaus, Gesundheitszentrum Wetterau gGmbH
Bad Nauheim, Hesse, 61231, Germany
Centrum für Hämatologie und Onkologie am Bethanien-Krankenhaus
Frankfurt am Main, Hesse, 60389, Germany
AGAPLESION Markus Krankenhaus
Frankfurt am Main, Hesse, 60431, Germany
Klinikum der J. W. Goethe Universität
Frankfurt am Main, Hesse, 60590, Germany
Klinikum Stadt Hanau
Hanau, Hesse, 63450, Germany
Elisabeth Krankenhaus
Kassel, Hesse, 34117, Germany
Klinikum Kassel GmbH, Gynäkologische Ambulanz
Kassel, Hesse, 34125, Germany
Sana Klinikum Offenbach
Offenbach, Hesse, 63069, Germany
Helios Klinik Wiesbaden
Wiesbaden, Hesse, 65199, Germany
Studien GbR Braunschweig
Braunschweig, Lower Saxony, 38100, Germany
MVZ II der Niels Stensen Kliniken
Georgsmarienhütte, Lower Saxony, 49124, Germany
DIAKOVERE Henriettenstift Gynäkologie
Hanover, Lower Saxony, 30559, Germany
Klinikum Oldenburg AöR
Oldenburg, Lower Saxony, 26133, Germany
MVZ in der Klinik Dr. Hancken
Stade, Lower Saxony, 21680, Germany
Gemeinschaftspraxis Dallacker / Eilers
Wolfenbüttel, Lower Saxony, 38304, Germany
Klinikum Südstadt
Rostock, Mecklenburg-Vorpommern, 18059, Germany
Onkologische Schwerpunktpraxis, Studiengesellschaft Onkologie Bielefeld GbR
Bielefeld, Nordrhein-Wastfalen, 33604, Germany
Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, 52074, Germany
Marienhospital Bottrop gGmbH
Bottrop, North Rhine-Westphalia, 46236, Germany
St. Elisabeth-Krankenhaus, Brustzentrum Köln-Hohenlind
Cologne, North Rhine-Westphalia, 50935, Germany
Kliniken der Stadt Köln
Cologne, North Rhine-Westphalia, 51067, Germany
St, Johannes Hospital
Dortmund, North Rhine-Westphalia, 44137, Germany
Heinrich-Heine-Universität Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Praxis Dr. B. Adhami
Erkelenz, North Rhine-Westphalia, 41812, Germany
Kliniken Essen-Mitte Evang. Huyssens-Stiftung/Knappschaft GmbH
Essen, North Rhine-Westphalia, 45136, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45147, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149, Germany
Oncologianova GmbH
Recklinghausen, North Rhine-Westphalia, 45659, Germany
Helios Universitätsklinikum Wuppertal
Wuppertal, North Rhine-Westphalia, 42283, Germany
Praxisklinik für Hämatologie und Onkologie
Koblenz, Rhineland-Palatinate, 56068, Germany
Uniklinikum, Klinik für Geburtshilfe und Gynäkologie
Mainz, Rhineland-Palatinate, 55131, Germany
MVZ Hämatologie-Onkologie Mayen/Koblenz GmbH
Mayen, Rhineland-Palatinate, 56729, Germany
Onkologische Schwerpunkt- Praxis Speyer
Speyer, Rhineland-Palatinate, 67346, Germany
Klinikum Worms
Worms, Rhineland-Palatinate, 67550, Germany
Caritasklinik St. Theresia
Saarbrücken, Saarland, 66113, Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, Saxony, 01307, Germany
Klinikum Obergöltzsch Rodewisch
Rodewisch, Saxony, 08228, Germany
Kreiskrankenhaus Torgau
Torgau, Saxony, 04860, Germany
Universitäsklinik Halle/Saale
Halle, Saxony-Anhalt, 06120, Germany
Johanniter Krankenhaus Genthin-Stendal
Stendal, Saxony-Anhalt, 39576, Germany
MediOnko-Institut GbR
Berlin, State of Berlin, 10367, Germany
SRH Wald-Klinikum Gera gGmbH, Brustzentrum Ostthüringen
Gera, Thuringia, 07548, Germany
MVZ Nordhausen gGmbH im Südharz Krankenhaus
Nordhausen, Thuringia, 99734, Germany
SRH Zentralklinikum Suhl
Suhl, Thuringia, 98527, Germany
Hämatologie-Onkologie im Zentrum MVZ GmbH
Augsburg, 86150, Germany
HELIOS Klinikum Berlin Buch
Berlin, 13125, Germany
Knappschaft Kliniken Marienhospital Bottrop GmbH, Klinik für Gynäkologie und Geburtshilfe
Bottrop, 46236, Germany
DONAUISAR Klinikum Deggendorf
Deggendorf, 94469, Germany
Rotkreuzklinikum München
München, 80634, Germany
Klinikum Passau
Passau, 94032, Germany
Klinikum Ernst von Bergmann gGmbH
Potsdam, 14467, Germany
MVZ für Hämatologie und Onkologie Ravensburg GmbH
Ravensburg, 88212, Germany
Schwarzwald-Baar-Klinikum
Villingen-Schwenningen, 78052, Germany
Universitätsklinikum Würzburg
Würzburg, 97080, Germany
Cork University Hospital
Cork, T12 DFK4, Ireland
St Vincent's University Hospital
Dublin, D04 T6F4, Ireland
St James's Hospital
Dublin, D08 NHY1, Ireland
Beaumont Hospital
Dublin, D09V2N0, Ireland
University Hospital Limerick
Limerick, V94 F858, Ireland
University Hospital Waterford
Waterford, X91 ER8E, Ireland
Hospital Universitario de Cruces
Barakaldo, Bizkaia, 48903, Spain
COMPLEJO HOSPITALARIO UNIVERSITARIO A CORUÑA-Hospital Teresa Herrera (CHUAC)
A Coruña, 15009, Spain
Complejo Hospitalario Universitario de Albacete
Albacete, 2006, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, 28922, Spain
Hospital Virgen de Los Lirios
Alcoy, 03804, Spain
Hospital General Universitario de Alicante
Alicante, 3010, Spain
Institut Catala D'oncologia
Badalona, 08916, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, 08041, Spain
Consorcio Hospitalario Provincial de Castellón
Castellon, 12002, Spain
Hospital San Pedro de Alcántara
Cáceres, 10003, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, 28942, Spain
Hospital Galdakao-Usansolo
Galdakao, 48960, Spain
Hospital Universitario Clinico San Cecilio
Granada, 18016, Spain
Complejo Hospitalario de Jaén
Jaén, 23007, Spain
Hospital Universitario Severo Ochoa
Leganés, 28911, Spain
Clinica Universidad de Navarra
Madrid, 28027, Spain
Hospital Universitario Ramón Y Cajal
Madrid, 28034, Spain
Hospital Universitario San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Consorci Sanitari Del Maresme
Mataró, 08304, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital General Universitario Morales Meseguer
Murcia, 3008, Spain
Hospital Clínico Universitario Virgen de La Arrixaca
Murcia, 30120, Spain
Hospital Universitari Son Llátzer
Palma de Mallorca, '07198, Spain
Hospital Universitari Son Espases
Palma de Mallorca, 07120, Spain
Clinica Universidad de Navarra
Pamplona, 31008, Spain
Hospital Universitario Quirónsalud Madrid
Pozuelo de Alarcón, 28223, Spain
Hospital Universitari Sant Joan de Reus
Reus, 43204, Spain
Parc Tauli Hospital Universitari
Sabadell, 08208, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, 38320, Spain
Hospital Universitario Ntra.Sra. de Candelaria
Santa Cruz de Tenerife, 38010, Spain
Complejo Hospitalario Universitario de Santiago (Chus)
Santiago de Compostela, 15706, Spain
Hospital Universitario Virgen de La Macarena
Seville, 41009, Spain
Hospital Quirónsalud Sagrado Corazón
Seville, 41013, Spain
University Hospital Virgen Del Rocio S.L.
Seville, 41013, Spain
Hospital Iniversitario De Toledo
Toledo, 45007, Spain
Fundación Instituto Valenciano de Oncología
Valencia, 46009, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Consorci Hospital General Universitari de Valencia
Valencia, 46014, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, 47003, Spain
Hospital Universitario Araba-Txagorritxu
Vitoria-Gasteiz, 01009, Spain
Kantonsspital Graubünden
Chur, 7000, Switzerland
Breast Center KSSG
Sankt Gallen, 9007, Switzerland
Brust-Zentrum Zürich
Zurich, 8008, Switzerland
Related Publications (1)
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
RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frederik Marmé, MD, Prof.
ASCO, ESMO, GBG, AGO, DKG, DGS, DKG
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2020
First Posted
October 20, 2020
Study Start
October 28, 2020
Primary Completion (Estimated)
March 30, 2027
Study Completion (Estimated)
March 30, 2029
Last Updated
April 22, 2026
Record last verified: 2026-04