NCT03412643 - Study of Neoadjuvant Chemotherapy Plus Trastuzumab and Pertuzumab in HER2-Negative Breast Cancer Patients With Abnormal HER2 Signaling | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 14, 2018

Primary Completion Date

October 30, 2023

Study Completion Date

October 30, 2023

Conditions

HER2-negative Breast Cancer

Interventions

DRUG

Doxorubicin

60 mg/m2 IV Day 1 every 2 weeks or 3 weeks at investigator's discretion for a total of 4 cycles

DRUG

Cyclophosphamide

600 mg/m2 IV Day 1 every 2 weeks or 3 weeks at investigator's discretion for a total of 4 cycles

DRUG

Weekly Paclitaxel

80 mg/m2 IV weekly for 12 doses

DRUG

Trastuzumab

loading dose of 8 mg/kg IV; then 6 mg/kg IV every 3 weeks for Cycles 2-4

DRUG

Pertuzumab

loading dose of 840 mg IV; then 420 mg IV every 3 weeks for Cycles 2-4

DIAGNOSTIC_TEST

Celcuity CELx HSF

Prior to drug interventions 3, 4,and 5, the Celcuity CELx HSF diagnostic test will be conducted to assess HER2 signaling activity

Trial Locations (43)

14642

RECRUITING

University of Rochester - Wilmot Cancer Institute, Rochester

17403

RECRUITING

Wellspan Health - York Cancer Center, York

21204

RECRUITING

Greater Baltimore Medical Center, Baltimore

23114

RECRUITING

Bon Secours St. Francis Medical Center, Midlothian

23116

RECRUITING

Bon Secours Richmond Community Hospital Medical Oncology Assoc., Mechanicsville

23226

RECRUITING

Bon Secours Richmond Community Hospital at St. Mary's, Richmond

24501

RECRUITING

Centra Lynchburg Hematology Oncology, Lynchburg

26506

RECRUITING

West Virginia University, Morgantown

32806

RECRUITING

University of Florida Cancer Center at Orlando Health, Orlando

33140

RECRUITING

Mount Sinai Comprehensive Cancer Center, Miami Beach

40202

RECRUITING

University of Louisville JG Brown Cancer Center, Louisville

43015

RECRUITING

Delaware Health Center, Delaware

43050

RECRUITING

Knox Community Hospital, Mount Vernon

43055

RECRUITING

Licking Memorial Hospital, Newark

43210

RECRUITING

Arthur G. James Cancer Hospital & Richard Solove Research Institute, Columbus

43214

RECRUITING

Columbus Oncology & Hematology Associates Inc, Columbus

43219

RECRUITING

The Mark H. Zangmeister Center, Columbus

43228

RECRUITING

Doctors Hospital, Columbus

43303

RECRUITING

Marion General Hospital, Marion

43701

RECRUITING

Genesis Health Care, Zanesville

44195

RECRUITING

Cleveland Clinic Taussig Cancer Center, Cleveland

44710

RECRUITING

Aultman Hospital, Canton

45420

RECRUITING

Dayton Clinical Oncology Program, Dayton

RECRUITING

Dayton Physicians LLC, Dayton

45601

RECRUITING

Adena Regional Medical Center, Columbus

45662

RECRUITING

Southern Ohio Medical Center, Portsmouth

45714

RECRUITING

Strecker Cancer Center-Belpre, Belpre

45750

RECRUITING

Marietta Memorial Hospital Cancer Center, Marietta

46804

RECRUITING

Fort Wayne Medical Oncology and Hematology, Inc., Fort Wayne

48106

RECRUITING

St. Joseph Mercy Hospital, Ann Arbor

48202

RECRUITING

Henry Ford Hospital, Detroit

48503

RECRUITING

Genesys Hurley Cancer Institute, Flint

48601

RECRUITING

Ascension St. Mary's, Saginaw

48912

RECRUITING

Herbert Herman Cancer Center, Sparrow Hospital, Lansing

52242

RECRUITING

University of Iowa, Iowa City

54915

RECRUITING

Ascension St. Elizabeth Hospital, Appleton

62526

RECRUITING

Cancer Care Specialists of Central Illinois, Decatur

70112

RECRUITING

University Medical Center New Orleans, New Orleans

77030

RECRUITING

Harris Health Systems-Smith Clinic, Houston

RECRUITING

Lester and Sue Smith Breast Center, Houston

92324

RECRUITING

Arrowhead Regional Medical Center, Colton

60540-7499

RECRUITING

Edward Hospital Cancer Center, Naperville

07112

RECRUITING

Newark Beth Israel Medical Center, Newark