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Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)

LAST UPDATED

June 27 2025

Clinicaltrials.gov ID

NCT05633654

OVERVIEW

A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy

PROTOCOL SUMMARY

The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.

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Participation Requirements

Calendar

Age

18 Years +

Condition

Sex

ALL

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

Triple Negative Breast Cancer

Gender

N/A

Date

December 2022 - June 2027

Study Type

INTERVENTIONAL

Study Phase

PHASE3

Product

Sacituzumab govitecan-hziy (SG), Pembrolizumab, Capecitabine

Eligibility Information

Inclusion

Inclusion Criteria

  • Age > 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery:
  • TNBC criteria for the study is defined as estrogen receptor (ER) and progesterone receptor (PR) ≤ 10%, human epidermal growth factor receptor 2 (HER2)-negative per American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) guidelines (immunohistochemistry (IHC) and/or in situ hybridization (ISH)).
  • Adequate excision and surgical removal of all clinically evident of disease in the breast and/or lymph nodes and have adequately recovered from surgery.
  • Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Individuals must have received appropriate radiotherapy and have recovered prior to starting study treatment.
  • Adequate organ function.
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Exclusion

Exclusion Criteria

  • Stage IV (metastatic) breast cancer as well as history of any prior (ipsi- or contralateral) invasive breast cancer.
  • Prior treatment with another stimulatory or coinhibitory T-cell receptor agent (eg, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), OX-40, cluster of differentiation 137 (CD137), prior treatment with any HER2-directed agent, prior endocrine therapy for > 4 weeks or planned concurrent endocrine therapy while receiving on-study treatment.
  • Evidence of recurrent disease following preoperative therapy and surgery.
  • Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor.
  • Individuals with germline breast cancer gene (BRCA) mutations.
  • Myocardial infarction or unstable angina pectoris within 6 months of enrollment or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias or Left ventricular ejection fraction (LVEF) of < 50%
  • Active serious infections requiring anti-microbial therapy.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Locations

Locations (224)
Recruiting

Alabama Oncology

Birmingham, Alabama, United States, 35243

Recruiting

Clearview Cancer Institute

Huntsville, Alabama, United States, 35805

Recruiting

Palo Verde Hematology Oncology

Glendale, Arizona, United States, 85304

Recruiting

Mayo Clinic Hospital

Phoenix, Arizona, United States, 85054

Withdrawn

Arizona Oncology Associates

Prescott Valley, Arizona, United States, 86314

Recruiting

Alta Bates Summit Medical Center

Berkeley, California, United States, 94704

Withdrawn

Community Cancer Institute

Clovis, California, United States, 93611

Recruiting

PIH Health Whittier Hospital

Downey, California, United States, 90241

Recruiting

Compassionate Cancer Care Medical Group - Inc

Fountain Valley, California, United States, 92708

Recruiting

Los Angeles Cancer Network

Los Angeles, California, United States, 90017

Withdrawn

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

Recruiting

Cedars-Sinai Cancer at Beverly Hills

Los Angeles, California, United States, 90048

Recruiting

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States, 92663

Withdrawn

Emad Ibrahim, MD, INC

Redlands, California, United States, 92373

Recruiting

Sutter Institute for Medical Research

Sacramento, California, United States, 95816

Recruiting

UCSF Medical Center

San Francisco, California, United States, 94143

Recruiting

Sansum Clinic

Santa Barbara, California, United States, 93105

Recruiting

Stockton Hematology Oncology Medical Group

Stockton, California, United States, 95204

Withdrawn

University of Colorado Cancer Center

Aurora, Colorado, United States, 80045

Withdrawn

Norwalk Hospital

Danbury, Connecticut, United States, 06810

Withdrawn

Stamford Hospital

Stamford, Connecticut, United States, 06902

Withdrawn

Morton Plant Hospital - Bay Care

Clearwater, Florida, United States, 00337

Withdrawn

University of Florida

Gainesville, Florida, United States, 32610

Recruiting

Mayo Clinic Florida

Jacksonville, Florida, United States, 32224

Recruiting

Cancer Specialists of North Florida

Jacksonville, Florida, United States, 32256

Recruiting

Jupiter Medical Center

Jupiter, Florida, United States, 33458

Recruiting

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States, 33140

Withdrawn

Midland Florida Clinical Research Center, L

Orange City, Florida, United States, 32763

Recruiting

Orlando Health

Orlando, Florida, United States, 32806

Withdrawn

Cancer Care Centers of Brevard, Inc

Palm Bay, Florida, United States, 32909

Recruiting

Memorial Healthcare System

Pembroke Pines, Florida, United States, 33028

Withdrawn

Sacred Heart Medical Oncology Group

Pensacola, Florida, United States, 32504

Recruiting

Sylvester Comprehensive Cancer Center

Plantation, Florida, United States, 33324

Withdrawn

Cleveland Clinic Florida, Martin North Hospital

Stuart, Florida, United States, 34994

Withdrawn

St. Joseph's Hospital

Tampa, Florida, United States, 33614

Withdrawn

Weston Hospital

Weston, Florida, United States, 33331

Recruiting

University Cancer & Blood Center, LLC.

Athens, Georgia, United States, 30607

Recruiting

Piedmont Cancer Institute

Atlanta, Georgia, United States, 30318

Recruiting

Northside Hospital

Atlanta, Georgia, United States, 30342

Recruiting

Northwest Georgia Oncology Centers, PC

Marietta, Georgia, United States, 30060

Recruiting

Pearlman Cancer Center

Valdosta, Georgia, United States, 31602

Withdrawn

St Lukes Mountain States Tumor Institute

Boise, Idaho, United States, 83712

Recruiting

Kootenai Health

Coeur d'Alene, Idaho, United States, 83814

Recruiting

Northwestern Medicine

Chicago, Illinois, United States, 60611

Recruiting

Rush University Medical Center

Chicago, Illinois, United States, 60612

Withdrawn

University of Illinois

Chicago, Illinois, United States, 60612

Recruiting

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

Recruiting

NorthShore University Healthsystem

Evanston, Illinois, United States, 60201

Recruiting

Edward Hospital

Naperville, Illinois, United States, 60540

Withdrawn

West Suburban Medical Center- River Forest

River Forest, Illinois, United States, 60305

Withdrawn

Edward H. Kaplan MD & Associates - Hematology/Oncology of the North Shore

Skokie, Illinois, United States, 60076

Withdrawn

Springfield Clinic LLP

Springfield, Illinois, United States, 62702

Recruiting

Carle Cancer Center

Urbana, Illinois, United States, 61801

Recruiting

Franciscan Health Indianapolis

Indianapolis, Indiana, United States, 46237

Withdrawn

Investigative Clinical Research of Indiana, LLC

Indianapolis, Indiana, United States, 46260

Withdrawn

IU Health Arnett Hospital

Lafayette, Indiana, United States, 47904

Withdrawn

Franciscan Health Munster

Munster, Indiana, United States, 46321

Recruiting

Mercy Medical Center

Cedar Rapids, Iowa, United States, 52403

Recruiting

Mission Cancer & Blood - John Stoddard Cancer Center

Des Moines, Iowa, United States, 50309

Recruiting

University of Iowa Hospitals and Clinics

Fairfield, Iowa, United States, 52556

Withdrawn

University of Kentucky

Lexington, Kentucky, United States, 40536

Recruiting

Norton Healthcare, Inc.

Louisville, Kentucky, United States, 40207

Recruiting

Mercy Health

Paducah, Kentucky, United States, 42003

Recruiting

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States, 70809

Withdrawn

University Medical Center New Orleans

New Orleans, Louisiana, United States, 70112

Recruiting

New England Cancer Specialists

Scarborough, Maine, United States, 04074

Recruiting

Sinai Hospital of Baltimore, Inc.

Baltimore, Maryland, United States, 21215

Recruiting

St. Agnes Hospital

Baltimore, Maryland, United States, 21229

Recruiting

Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States, 21231

Recruiting

Medstar Franklin Square Medical Center

Baltimore, Maryland, United States, 21237

Withdrawn

American Oncology Partners of Maryland, PA

Bethesda, Maryland, United States, 20817

Recruiting

James M Stockman Cancer Institute

Frederick, Maryland, United States, 21702

Recruiting

Greater Baltimore Medical Center

Towson, Maryland, United States, 21204

Recruiting

Tufts Medical Center

Boston, Massachusetts, United States, 02111

Recruiting

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Recruiting

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Withdrawn

Baystate Medical Center Inc.

Springfield, Massachusetts, United States, 01199

Recruiting

University of Massachusetts Worcester

Worcester, Massachusetts, United States, 01655

Recruiting

Henry Ford Health System

Detroit, Michigan, United States, 48202

Recruiting

Cancer and Hematology Centers of Western Michigan

Grand Rapids, Michigan, United States, 49503

Withdrawn

Ascension

Grosse Pointe Woods, Michigan, United States, 48236

Recruiting

William Beaumont Hospital

Royal Oak, Michigan, United States, 48073

Recruiting

Ascension Providence Hospital Southfield Cancer Center

Southfield, Michigan, United States, 48075

Withdrawn

Trinity Health St. Joseph Mercy Ann Arbor

Ypsilanti, Michigan, United States, 48197

Recruiting

Minnesota Oncology Hematology, PA

Maplewood, Minnesota, United States, 55109

Recruiting

Virginia Piper Cancer Center (Allina Health)

Minneapolis, Minnesota, United States, 55407

Recruiting

University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, United States, 55455

Recruiting

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

Recruiting

Metro Minnesota Community Oncology

Saint Louis Park, Minnesota, United States, 55426

Recruiting

Baptist Clinical Research Institute

Saint Louis, Missouri, United States, 63131

Withdrawn

Mercy Hospital

Saint Louis, Missouri, United States, 63141

Recruiting

Mary Lanning Healthcare - Morrison Cancer Center

Hastings, Nebraska, United States, 68901

Recruiting

Oncology Hematology West - Methodist

Omaha, Nebraska, United States, 68114

Recruiting

Nebraska Methodist Hospital (change from Chi Health Bergan Mercy)

Omaha, Nebraska, United States, 68124

Withdrawn

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States, 89169

Withdrawn

Cancer Care & Hematology Specialists

Reno, Nevada, United States, 89511

Recruiting

Regional Cancer Care Associates LLC

East Brunswick, New Jersey, United States, 08816

Recruiting

Hunterdon Medical Center

Flemington, New Jersey, United States, 08822

Withdrawn

Summit Medical Group, P.A.

Florham Park, New Jersey, United States, 07932

Recruiting

Rutgers Health

New Brunswick, New Jersey, United States, 08901

Recruiting

Overlook Medical Center

Summit, New Jersey, United States, 07901

Recruiting

University of New Mexico

Albuquerque, New Mexico, United States, 87131

Recruiting

San Juan Oncology Associates

Farmington, New Mexico, United States, 87401

Withdrawn

New York Oncology Hematology (NYOH)

Amsterdam, New York, United States, 12010

Withdrawn

Montefiore Medical Center

Bronx, New York, United States, 10467

Recruiting

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Recruiting

Hematology Oncology Associates of Central New York, PC

East Syracuse, New York, United States, 13057

Withdrawn

Northwell Health

Lake Success, New York, United States, 11042

Recruiting

Laura and Isaac Perlmutter Cancer Canter

New York, New York, United States, 10016

Recruiting

Lipson Cancer Institute - Linden Oaks

Rochester, New York, United States, 14618

Recruiting

New York Cancer and Blood Specialists

Shirley, New York, United States, 11967

Recruiting

Stony Brook Medicine

Stony Brook, New York, United States, 11794

Recruiting

SUNY Upstate Medical University

Syracuse, New York, United States, 13210

Withdrawn

Clinical Research Alliance

Westbury, New York, United States, 11590

Recruiting

White Plains Hospital Physician Associates

White Plains, New York, United States, 10601

Recruiting

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States, 27514

Recruiting

Duke Cancer Institute

Durham, North Carolina, United States, 27710

Recruiting

Cone Health Medical Group (Moses Cone Health System)

Greensboro, North Carolina, United States, 27403

Recruiting

East Carolina University Health Medical Center

Greenville, North Carolina, United States, 27834

Withdrawn

FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina, United States, 28374

Recruiting

UNC Rex Cancer Center

Raleigh, North Carolina, United States, 27607

Withdrawn

UNC Nash Cancer Center

Rocky Mount, North Carolina, United States, 27804

Recruiting

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States, 27157

Recruiting

Good Samaritan Hospital

Cincinnati, Ohio, United States, 45220

Recruiting

Oncology Hematology Care, Inc.

Cincinnati, Ohio, United States, 45242

Recruiting

Ohio State University CRS

Columbus, Ohio, United States, 43212

Recruiting

Ohio Health Research Institute

Columbus, Ohio, United States, 43214

Recruiting

Anita Stewart Oncology Center

Columbus, Ohio, United States, 43221

Will Be Recruiting

Toledo Clinic Cancer Center

Toledo, Ohio, United States, 43623

Withdrawn

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Recruiting

St. Charles Health System, Inc. DBA St. Charles Medical Center

Bend, Oregon, United States, 97701

Recruiting

Samaritan Hospital

Corvallis, Oregon, United States, 97330

Recruiting

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, United States, 97401

Withdrawn

Asante Rogue Regional Medical Center

Medford, Oregon, United States, 97504

Withdrawn

Providence Cancer Institute - Oncology Clinical Trials

Portland, Oregon, United States, 97213

Recruiting

Oregon Health & Science University

Portland, Oregon, United States, 97239

Withdrawn

Saint Luke's University Hospital

Bethlehem, Pennsylvania, United States, 18015

Recruiting

Lancaster General Health

Lancaster, Pennsylvania, United States, 17601

Recruiting

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, United States, 19104

Recruiting

Guthrie Clinical Research

Sayre, Pennsylvania, United States, 18840

Withdrawn

Reading Hospital and Medical Center

West Reading, Pennsylvania, United States, 19611

Recruiting

Lankenau Medical Center

Wynnewood, Pennsylvania, United States, 19106

Recruiting

Cancer Care Associates of York

York, Pennsylvania, United States, 17403

Recruiting

Providence Health

Providence, Rhode Island, United States, 02905

Recruiting

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Recruiting

Spartanburg Medical Center

Spartanburg, South Carolina, United States, 29303

Recruiting

Monument Health Cancer Care Institute

Rapid City, South Dakota, United States, 57701

Recruiting

Avera Cancer Institute

Sioux Falls, South Dakota, United States, 57105

Withdrawn

Ballad Health Cancer Care - Kingsport

Kingsport, Tennessee, United States, 37660

Withdrawn

Center for Biomedical Research, LLC

Knoxville, Tennessee, United States, 37909

Recruiting

University of Tennessee

Knoxville, Tennessee, United States, 37920

Withdrawn

Hendrick Health System

Abilene, Texas, United States, 79601

Recruiting

Texas Oncology

Austin, Texas, United States, 78731

Recruiting

Texas Oncology

El Paso, Texas, United States, 79902

Recruiting

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Recruiting

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, United States, 79410

Recruiting

Texas Oncology

San Antonio, Texas, United States, 78240

Recruiting

Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84112

Recruiting

University of Virginia

Charlottesville, Virginia, United States, 22908

Withdrawn

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States, 23298

Recruiting

Oncology and Hematology Associates of Southwest Virginia, Inc

Wytheville, Virginia, United States, 24382

Recruiting

Providence Regional Cancer System

Lacey, Washington, United States, 98503

Recruiting

MultiCare Regional Cancer Center - Tacoma

Puyallup, Washington, United States, 98372

Recruiting

Northwest Medical Specialties, PLLC

Puyallup, Washington, United States, 98373

Withdrawn

University of Washington

Renton, Washington, United States, 98055

Withdrawn

Medical Oncology Associates

Spokane, Washington, United States, 99208

Recruiting

West Virginia University Hospital

Morgantown, West Virginia, United States, 26505

Withdrawn

ThedaCare Regional Cancer Center

Appleton, Wisconsin, United States, 54911

Recruiting

Ascension St. Francis Reiman Cancer Center

Franklin, Wisconsin, United States, 53132

Recruiting

HSHS Saint Mary's Hospital Medical Center - Green Bay

Green Bay, Wisconsin, United States, 54303

Withdrawn

University of Wisconsin

Madison, Wisconsin, United States, 53792

Will Be Recruiting

Macarthur Cancer Therapy Centre, Campbelltown Hospital

Campbelltown, New South Wales, Australia, 2560

Recruiting

Lake Macquarie Private Hospital

Gateshead, New South Wales, Australia, 2290

Recruiting

Monash Medical Centre

Clayton, Victoria, Australia, 3168

Recruiting

Pôle Santé Léonard De Vinci - ROC37

Chambray les Tours, France, 37170

Recruiting

Clinique Victor Hugo

Le Mans, France, 72000

Recruiting

Hôpital Privé Jean Mermoz

Lyon, France, 69008

Recruiting

Hopital Privé des Côtes d'Armor - Centre CARIO-HPCA

Plerin, France, 22190

Recruiting

Centre Eugène Marquis

Rennes cedex, France, 35042

Recruiting

Oncopole Claudius Regaud - IUCT-O

Toulouse, France, 31059

Recruiting

Hämatologie-Onkologie im Zentrum MVZ GmbH

Augsburg, Germany, 86150

Recruitment Complete

Schwanebecker Chaussee 50

Berlin, Germany, 13125

Recruiting

Teutoburger Str. 60

Bielefeld, Germany, 33604

Recruiting

Josef-Albers-Str.70

Bottrop, Germany, 46236

Recruiting

Studien GbR Braunschweig

Braunschweig, Germany, 38100

Recruiting

Hämato-Onkologische Praxis im Medicum

Bremen, Germany, 28209

Recruiting

St. Johannes Hospital

Dortmund, Germany, 44137

Recruiting

Klinikum Esslingen

Esslingen, Germany, 73730

Recruiting

MVZ II der Niels Stensen Kliniken

Georgsmarienhütte, Germany, 49124

Recruiting

Moorkamp 2-6

Hamburg, Germany, 20357

Recruitment Complete

Edgar-von-Gierke-Straße 2

Karlsruhe, Germany, 76137

Recruiting

Elisabeth Krankenhaus Brustzentrum

Kassel, Germany, 34117

Recruiting

InVO - Institut für Versorgungsforschung in der Onkologie GbR / Praxis für Hämatologie und Onkologie

Koblenz, Germany, 56068

Recruiting

St. Elisabeth Krankenhaus GmbH

Köln, Germany, 50935

Recruiting

Universitätsklinikum Mannheim

Mannheim, Germany, 68167

Recruiting

Elisabethenstr. 19, 88212 Ravensburg

Ravensburg, Germany, 88212

Recruitment Complete

Harsefelderstraße 8

Stade, Germany, 21680

Recruitment Complete

Böheimstr. 37

Stuttgart, Germany, 70199

Recruitment Complete

Calwerstrasse 7

Tuebingen, Germany, 72076

Recruiting

Klinikum Worms Frauenklinik

Worms, Germany, 67550

Recruiting

Helios University Hospital University Witten/Herdecke

Wuppertal, Germany, 42283

Recruiting

St James's Hospital

Dublin, Ireland, D08NH41

Recruiting

Medical Oncology Unit. A Coruña University Hospital

A Coruña, Spain, 15006

Recruiting

ICO Badalona - Hospital Germans Trias I Pujol

Badalona, Spain, 08916

Recruiting

Hospital Universitary of Cruces

Barakaldo, Spain, 48903

Recruiting

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Recruiting

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain, 8041

Recruiting

Hospital Universitario San Pedro de Alcántara

Caceres, Spain, 10003

Recruiting

Consorcio Hospitalario Provincial de Castellón

Castellón, Spain, 12002

Recruiting

Hospital General Universitario De Elche

Elche, Spain, 03203

Recruiting

Hospital Galdakao

Galdakao, Spain, 48960

Recruiting

Hospital Universitario Virgen de las Nieves

Granada, Spain, 18014

Recruiting

Hospital Universitario Clínico San Cecilio

Granada, Spain, 18016

Recruiting

Hospital Universitario de Jaen

Jaen, Spain, 23007

Recruiting

Hospital Universitario Virgen de la Victoria

Malaga, Spain, 29010

Recruiting

Althaia Xarxa Assistencial de Manresa

Manresa, Spain, 08242

Recruiting

Hospital Universitario Morales Meseguer

Murcia, Spain, 30008

Recruiting

Clínica Universidad de Navarra - Madrid

Pamplona, Spain, 31008

Recruiting

HU Marqués de Valdecilla

Santander, Spain, 39008

Recruiting

Hospital Universitario Virgen Macarena

Sevilla, Spain, 41009

Recruiting

Hospital Quironsalud Sagrado Corazón

Seville, Spain, 41010

Recruiting

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Recruiting

Hospital Clinico Universitario de Valladolid

Valladolid, Spain, 47003

Recruiting

Isabel la Catolica nº 1-3

Zaragoza, Spain, 50009