Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

ePoster Display

199TiP - Phase III post-neoadjuvant study evaluating sacituzumab govitecan (SG), an antibody drug conjugate in primary HER2-negative breast cancer patients with high relapse risk after standard neoadjuvant treatment: SASCIA

Date

16 Sep 2021

Session

ePoster Display

Presenters

Frederik Marmé

Citation

Annals of Oncology (2021) 32 (suppl_5): S407-S446. 10.1016/annonc/annonc687

Authors

F. Marmé1, C. Hanusch2, J. Furlanetto3, C. Denkert4, T. Link5, M. Untch6, J. Blohmer7, C. Jackisch8, M. Reinisch9, K.E. Rhiem10, A. Schneeweiss11, C. Solbach12, L. Schöllhorn3, P.A. Fasching13, J. Rey3, S. Loibl3

Author affiliations

  • 1 Gynecologic Oncology Department, UMM - Universitaetsklinikum Mannheim - Medizinische Fakultaet, 68167 - Mannheim/DE
  • 2 Gynäkologie Und Geburtshilfe, Rotkreuzklinikum München, München/DE
  • 3 Department Of Medicine And Research, German Breast Group (GBG) Forschungs GmbH, 63263 - Neu-Isenburg/DE
  • 4 Institute Of Pathology, Uniklinikum Giessen und Marburg, 35043 - Marburg/DE
  • 5 Department Of Obstetrics And Gynecology, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden/DE
  • 6 Clinic For Gynecology, Gynecologic Oncology And Obstetrics, Helios Klinikum Berlin Buch, 13125 - Berlin/DE
  • 7 7. gynäkologie Mit Brustzentrum, Charité-Univesitätsmedizin Berlin, Berlin/DE
  • 8 Department Of Obstetrics And Gynecology, Sana Klinikum Offenbach GmbH, 63069 - Offenbach am Main/DE
  • 9 Breast Unit, Kliniken Essen Mitte Evang. Huyssens-Stiftung, 45136 - Essen/DE
  • 10 Center For Familial Breast And Ovarian Cancer, University Hospital Cologne, 50937 - Köln/DE
  • 11 Universitätsklinikum Und Deutsches Krebsforschungszentrum, Heidelberg, 11. Nationales Centrum für Tumorerkrankungen, Heidelberg/DE
  • 12 Gynecology, Senology, Universitätsklinikum Frankfurt(Johannes-Wolfgang Goethe Institute), 60590 - Frankfurt am Main/DE
  • 13 Department Of Gynecology And Obstetrics, University Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN, University Erlangen-Nurembergen, Erlangen/DE
More

Abstract 199TiP

Background

Women with triple-negative breast cancer (TNBC) with residual disease after neoadjuvant chemotherapy (NACT) or hormone-receptor (HR)-positive/HER2-negative breast cancer (BC) with a CPS (clinical and post treatment pathological stage) +EG (estrogen receptor status and grade) score ≥3 or score 2 and nodal involvement after NACT (ypN+) are at high risk of recurrence. SG is approved by the Food and Drug Administration for the treatment of patients with metastatic TNBC who received at least two prior therapies for metastatic disease and has shown activity in heavily pretreated patients with metastatic HR-positive/HER2-negative BC. SG may represent a new option against residual disease after NACT.

Trial design

SASCIA is a phase III, prospective, international, multicenter, randomized, open label, parallel group study (NCT04595565) of the GBG in collaboration with the AGO-B. Eligible patients must have received taxane-based NACT for 16 weeks, including 6 weeks of a taxane. Patients should have centrally confirmed HER2-negative BC (IHC score 0-1 or FISH negative) and either HR-negative (<1%), with any residual invasive disease > ypT1mi or HR-positive (≥1%), with a CPS+EG score ≥3 or CPS+EG score 2 and ypN+. Radiotherapy should be delivered before study treatment start. Patients are randomized 1:1 to receive either SG 10 mg/kg body weight (days 1, 8 q3w for eight cycles) or treatment of physician´s choice (capecitabine 2000 mg/m2 day 1-14 q21 or platinum-based chemotherapy i.e. carboplatin AUC 5 q3w or AUC 1.5 weekly for eight 3 weekly cycles or observation). Randomization is stratified by HR status (positive, negative) and nodal involvement after NACT (ypN+, ypN0). Endocrine-based therapy will be administered according to local guidelines. The primary endpoint is invasive disease-free survival (iDFS). Secondary endpoints include overall survival (OS, key secondary endpoint), distant DFS, locoregional recurrence-free interval, safety, compliance, patient reported outcome, and quality of life. As of 29th April 2021, 33/1200 patients have been randomized in Germany.

Clinical trial identification

NCT04595565.

Editorial acknowledgement

Legal entity responsible for the study

German Breast Group (GBG Forschungs GmbH).

Funding

Gilead Sciences, Inc.

Disclosure

F. Marmé: Other, Personal and Institutional, Research Grant: AstraZeneca; Financial Interests, Personal, Other: MSD; Financial Interests, Personal, Other: Clovis; Financial Interests, Personal, Other: GSK/Tesaro; Financial Interests, Personal, Other: Pfizer; Financial Interests, Personal, Other: Novartis; Financial Interests, Personal, Other: Lilly; Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: Celgene; Financial Interests, Personal, Other: Seagen; Financial Interests, Personal, Other: Myriad; Financial Interests, Personal, Other: PharmaMar; Financial Interests, Personal, Other: Eisai; Financial Interests, Personal, Other: Janssen-Cilag. C. Hanusch: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: Celgene. C. Denkert: Other, Institutional, Research Grant: European Commission H2020; Other, Institutional, Research Grant: German Cancer Aid Translational Oncology; Financial Interests, Personal, Other: Novartis; Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: MSD Oncology; Financial Interests, Personal, Other: Daiichi Sankyo; Financial Interests, Personal, Other: AstraZeneca; Other, Personal, Other: Molecular Health; Other, Institutional, Research Grant: Myriad; Financial Interests, Personal, Other: Merck; Financial Interests, Personal and Institutional, Ownership Interest, Cofounder/shareholder until 2016: Sividon diagnostics; Financial Interests, Personal and Institutional, Royalties: VMScope digital pathology software; Financial Interests, Personal and Institutional, Other, patent pending: WO2020109570A1 - cancer immunotherapy; Financial Interests, Personal and Institutional, Other, patent issued: WO2015114146A1 and WO2010076322A1- therapy response. T. Link: Financial Interests, Personal, Other: Tesaro; Financial Interests, Personal, Other: MSD; Non-Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: Novartis; Non-Financial Interests, Personal, Other: Pfizer; Financial Interests, Personal, Other: Amgen; Non-Financial Interests, Personal, Other: Clovis; Financial Interests, Personal, Other: Celgene; Financial Interests, Personal, Other: Lilly; Financial Interests, Personal, Other: Myriad; Financial Interests, Personal, Other: Esai; Financial Interests, Personal, Other: GSK. M. Untch: Non-Financial Interests, Institutional, Other: AbbVie; Non-Financial Interests, Institutional, Other: Amgen; Non-Financial Interests, Institutional, Other: AstraZeneca; Non-Financial Interests, Institutional, Other: BMS; Non-Financial Interests, Institutional, Other: Celgene; Non-Financial Interests, Institutional, Other: Daiichi Sankyo; Non-Financial Interests, Institutional, Other: Eisai; Non-Financial Interests, Institutional, Other: Lilly; Non-Financial Interests, Institutional, Other: MSD Merck; Non-Financial Interests, Institutional, Other: Mundipharma; Non-Financial Interests, Institutional, Other: Myriad Genetics; Non-Financial Interests, Institutional, Other: Pfizer; Non-Financial Interests, Institutional, Other: Roche; Non-Financial Interests, Institutional, Other: Sanofi Aventis Deutschland GmbH; Non-Financial Interests, Institutional, Other: TEVA Pharmaceuticals Ind Ltd.; Non-Financial Interests, Institutional, Other: Novartis; Financial Interests, Personal and Institutional, Other: Pierre Fabre; Non-Financial Interests, Institutional, Other: Clovis Oncology; Financial Interests, Personal and Institutional, Other: Seattle Genetics; Financial Interests, Personal and Institutional, Other: Seagen. J. Blohmer: Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Exact Science; Financial Interests, Personal, Invited Speaker: MSD Oncology; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Sysmex; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Sonoscape. C. Jackisch: Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: Novartis; Financial Interests, Personal, Other: Exact Sciences; Financial Interests, Personal, Other: Prizer; Financial Interests, Personal, Other: Lilly; Financial Interests, Personal, Other: Pierrre-Fabre. K.E. Rhiem: Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: Pfizer; Financial Interests, Personal, Other: MSD. A. Schneeweiss: Other, Personal and Institutional, Research Grant, Travel expenses, Honoraria: Celgene; Other, Personal and Institutional, Research Grant, Expert testimony, Travel expenses, Honoraria, Medical writing: Roche; Other, Institutional, Research Grant: AbbVie; Financial Interests, Personal, Expert Testimony, Honoraria: AstraZeneca; Financial Interests, Personal, Other, Honoraria, Travel Expenses: Pfizer; Financial Interests, Personal, Other, Honoraria: Novartis; Financial Interests, Personal, Other, Honoraria: MSD; Financial Interests, Personal, Other, Honoraria: Tesaro; Financial Interests, Personal, Other, Honoraria: Lilly. P.A. Fasching: Financial Interests, Personal, Other: Novartis; Other, Institutional, Research Grant: BioNTech; Financial Interests, Personal, Other: Pfizer; Financial Interests, Personal, Other: Daiichi Sankyo; Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: Eisai; Financial Interests, Personal, Other: Merck Sharp & Dohme; Other, Institutional, Research Grant: Cepheid; Financial Interests, Personal, Other: Lilly; Financial Interests, Personal, Other: Pierre Fabre; Financial Interests, Personal, Other: Seagen; Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: Hexal; Financial Interests, Personal, Other: Agendia. S. Loibl: Non-Financial Interests, Institutional, Writing Engagements: Gilead; Non-Financial Interests, Institutional, Advisory Board: AbbVie; Non-Financial Interests, Institutional, Advisory Board, Medical Writing: Amgen; Non-Financial Interests, Institutional, Research Grant, Medical Writing, Ad Board: AstraZeneca; Other, Institutional, Advisory Board: Bayer; Non-Financial Interests, Institutional, Advisory Board, Medical Writing: BMS; Non-Financial Interests, Institutional, Research Grant, Medical Writing, Ad Board: Celgene; Financial Interests, Personal, Invited Speaker: Chugai; Non-Financial Interests, Institutional, Invited Speaker, Medical Writing, Ad Board: Daiichi Sankyo; Other, Institutional, Advisory Board: Eirgenix; Other, Institutional, Advisory Board: GSK; Non-Financial Interests, Institutional, Research Grant, Medical Writing, Ad Board, Invited Speaker: Novartis; Other, Institutional, Other: Ipsen; Other, Institutional, Advisory Board: Lilly; Other, Institutional, Advisory Board: Merck; Non-Financial Interests, Institutional, Research Grant, Medical Writing, Ad Board, Invited Speaker: Pfizer; Other, Institutional, Advisory Board, Invited Speaker: Pierre Fabre; Other, Institutional, Advisory Board, Invited Speaker: Prime/Medscape; Other, Institutional, Advisory Board: Puma; Non-Financial Interests, Institutional, Research Grant, Medical Writing, Ad Board, Invited Speaker: Roche; Other, Institutional, Invited Speaker: Samsung; Other, Institutional, Advisory Board: Seagen; Non-Financial Interests, Institutional, Research Grant, Medical Writing: Vifor; Financial Interests, Personal and Institutional, Other, patent issued: EP18209672.7; Financial Interests, Personal and Institutional, Other, patent pending: EP21152186.9; Financial Interests, Personal and Institutional, Other, patent issued: EP15702464.7; Financial Interests, Personal and Institutional, Licensing Fees: VM Scope GmbH. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.