Testing the Role of FDG-PET/CT to Predict Response to Therapy Prior to Surgery for HER2-positive Breast Cancer, The DIRECT Trial

PHASE2RecruitingINTERVENTIONAL
Enrollment

235

Participants

Timeline

Start Date

May 10, 2023

Primary Completion Date

May 31, 2027

Study Completion Date

December 31, 2029

Conditions
Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8HER2-Positive Breast CarcinomaInvasive Breast Carcinoma
Interventions
DRUG

Chemotherapy

Receive standard of care chemotherapy

PROCEDURE

Computed Tomography

Undergo PET/CT

OTHER

Fludeoxyglucose F-18

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

PROCEDURE

Surgical Procedure

Undergo standard of care surgery

Trial Locations (102)

10461

RECRUITING

Montefiore Medical Center-Einstein Campus, The Bronx

14263

RECRUITING

Roswell Park Cancer Institute, Buffalo

17822

RECRUITING

Geisinger Medical Center, Danville

18510

RECRUITING

Community Medical Center, Scranton

18711

RECRUITING

Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre

18840

RECRUITING

Guthrie Medical Group PC-Robert Packer Hospital, Sayre

19010

RECRUITING

Bryn Mawr Hospital, Bryn Mawr

19063

RECRUITING

Riddle Memorial Hospital, Media

19073

SUSPENDED

Bryn Mawr Health Center, Newtown Square

19096

RECRUITING

Lankenau Medical Center, Wynnewood

19301

RECRUITING

Paoli Memorial Hospital, Paoli

19380

RECRUITING

Chester County Hospital, West Chester

20016

RECRUITING

Sibley Memorial Hospital, Washington D.C.

21287

RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

23298

RECRUITING

Virginia Commonwealth University/Massey Cancer Center, Richmond

27599

RECRUITING

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

35233

RECRUITING

University of Alabama at Birmingham Cancer Center, Birmingham

38017

RECRUITING

Baptist Memorial Hospital and Cancer Center-Collierville, Collierville

38120

RECRUITING

Baptist Memorial Hospital and Cancer Center-Memphis, Memphis

38655

RECRUITING

Baptist Memorial Hospital and Cancer Center-Oxford, Oxford

38671

RECRUITING

Baptist Memorial Hospital and Cancer Center-Desoto, Southhaven

40202

RECRUITING

The James Graham Brown Cancer Center at University of Louisville, Louisville

43210

RECRUITING

Ohio State University Comprehensive Cancer Center, Columbus

44109

RECRUITING

MetroHealth Medical Center, Cleveland

45429

RECRUITING

Kettering Medical Center, Kettering

45431

RECRUITING

Indu and Raj Soin Medical Center, Beavercreek

48201

RECRUITING

Wayne State University/Karmanos Cancer Institute, Detroit

53022

RECRUITING

Aurora Health Care Germantown Health Center, Germantown

53105

RECRUITING

Aurora Cancer Care-Southern Lakes VLCC, Burlington

53215

RECRUITING

Aurora Saint Luke's Medical Center, Milwaukee

53227

RECRUITING

Aurora West Allis Medical Center, West Allis

53233

RECRUITING

Aurora Sinai Medical Center, Milwaukee

53792

RECRUITING

University of Wisconsin Carbone Cancer Center - University Hospital, Madison

54301

RECRUITING

Saint Vincent Hospital Cancer Center Green Bay, Green Bay

54303

RECRUITING

Saint Vincent Hospital Cancer Center at Saint Mary's, Green Bay

54449

SUSPENDED

Marshfield Medical Center-Marshfield, Marshfield

54456

SUSPENDED

Marshfield Medical Center - Neillsville, Neillsville

54476

RECRUITING

Marshfield Medical Center - Weston, Weston

54482

RECRUITING

Marshfield Medical Center-River Region at Stevens Point, Stevens Point

54494

SUSPENDED

Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids

54548

RECRUITING

Marshfield Clinic-Minocqua Center, Minocqua

54701

RECRUITING

Marshfield Medical Center-EC Cancer Center, Eau Claire

54848

RECRUITING

Marshfield Medical Center - Ladysmith, Ladysmith

54868

RECRUITING

Marshfield Medical Center-Rice Lake, Rice Lake

55102

SUSPENDED

United Hospital, Saint Paul

55109

SUSPENDED

Minnesota Oncology Hematology PA-Maplewood, Maplewood

55125

SUSPENDED

Minnesota Oncology Hematology PA-Woodbury, Woodbury

55337

SUSPENDED

Minnesota Oncology - Burnsville, Burnsville

55407

SUSPENDED

Abbott-Northwestern Hospital, Minneapolis

55416

RECRUITING

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park

55433

SUSPENDED

Mercy Hospital, Coon Rapids

55905

RECRUITING

Mayo Clinic in Rochester, Rochester

60045

RECRUITING

Northwestern Medicine Lake Forest Hospital, Lake Forest

60115

RECRUITING

Northwestern Medicine Cancer Center Kishwaukee, DeKalb

60134

RECRUITING

Northwestern Medicine Cancer Center Delnor, Geneva

60555

RECRUITING

Northwestern Medicine Cancer Center Warrenville, Warrenville

60611

RECRUITING

Northwestern University, Chicago

61801

RECRUITING

Carle Cancer Center, Urbana

61832

RECRUITING

Carle at The Riverfront, Danville

61938

RECRUITING

Carle Physician Group-Mattoon/Charleston, Mattoon

62401

RECRUITING

Carle Physician Group-Effingham, Effingham

63128

RECRUITING

Mercy Hospital South, St Louis

65807

RECRUITING

CoxHealth South Hospital, Springfield

68118

RECRUITING

Nebraska Medicine-Village Pointe, Omaha

68123

RECRUITING

Nebraska Medicine-Bellevue, Bellevue

68198

RECRUITING

University of Nebraska Medical Center, Omaha

70112

RECRUITING

Louisiana State University Health Science Center, New Orleans

RECRUITING

University Medical Center New Orleans, New Orleans

73104

RECRUITING

University of Oklahoma Health Sciences Center, Oklahoma City

78701

RECRUITING

Dell Seton Medical Center at The University of Texas, Austin

78712

RECRUITING

University of Texas at Austin, Austin

83301

RECRUITING

Saint Luke's Cancer Institute - Twin Falls, Twin Falls

84112

RECRUITING

Huntsman Cancer Institute/University of Utah, Salt Lake City

85004

RECRUITING

Cancer Center at Saint Joseph's, Phoenix

90033

RECRUITING

Los Angeles General Medical Center, Los Angeles

RECRUITING

USC / Norris Comprehensive Cancer Center, Los Angeles

90404

RECRUITING

Saint John's Cancer Institute, Santa Monica

96701

NOT_YET_RECRUITING

Hawaii Cancer Care - Westridge, ‘Aiea

96734

RECRUITING

Castle Medical Center, Kailua

96766

NOT_YET_RECRUITING

Wilcox Memorial Hospital and Kauai Medical Clinic, Lihue

96813

NOT_YET_RECRUITING

Hawaii Cancer Care Inc - Waterfront Plaza, Honolulu

NOT_YET_RECRUITING

Queen's Cancer Cenrer - POB I, Honolulu

NOT_YET_RECRUITING

Queen's Medical Center, Honolulu

NOT_YET_RECRUITING

University of Hawaii Cancer Center, Honolulu

96817

NOT_YET_RECRUITING

Queen's Cancer Center - Kuakini, Honolulu

96826

NOT_YET_RECRUITING

Kapiolani Medical Center for Women and Children, Honolulu

98109

RECRUITING

FHCC South Lake Union, Seattle

RECRUITING

Fred Hutchinson Cancer Center, Seattle

98195

RECRUITING

University of Washington Medical Center - Montlake, Seattle

32224-9980

RECRUITING

Mayo Clinic in Florida, Jacksonville

02215

RECRUITING

Dana-Farber Cancer Institute, Boston

08103

RECRUITING

Cooper Hospital University Medical Center, Camden

07960

RECRUITING

Morristown Medical Center, Morristown

08062

RECRUITING

Inspira Medical Center Mullica Hill, Mullica Hill

07503

RECRUITING

Saint Joseph's Regional Medical Center, Paterson

08360

RECRUITING

Inspira Medical Center Vineland, Vineland

08043

RECRUITING

MD Anderson Cancer Center at Cooper-Voorhees, Voorhees Township

00959-5060

SUSPENDED

Cancer Center-Metro Medical Center Bayamon, Bayamón

00674

SUSPENDED

Doctors Cancer Center, Manatí

00917

SUSPENDED

San Juan Community Oncology Group, San Juan

00927

SUSPENDED

Centro Comprensivo de Cancer de UPR, San Juan

00936

SUSPENDED

San Juan City Hospital, San Juan

All Listed Sponsors
lead

ECOG-ACRIN Cancer Research Group

NETWORK