Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

November 13, 2019

Study Completion Date

November 13, 2019

Conditions
HER2-Positive Metastatic Breast CancerHER2-Negative Metastatic Breast CancerLocally Advanced or Early Breast Cancer
Interventions
DRUG

Atezolizumab

Atezolizumab 1200 milligrams (mg) or 840 mg (Cohort 1E only) flat dose administered via intravenous (IV) infusion on Day 1 of every 21-day cycle.

DRUG

Carboplatin

Carboplatin will be administered at an initial target of area under the curve (AUC) of 6 milligrams per milliliter\*min (mg/mL\*min) via an IV infusion on Day 1 of every 21-days for 6 cycles.

DRUG

Docetaxel

Docetaxel 75 mg/m\^2 administered via IV infusion on Day 1 every 21-days for 6 cycles.

DRUG

Pertuzumab

Pertuzumab 840 mg loading dose then 420 mg administered via IV infusion on Day 1 of every 21-day cycle.

DRUG

Trastuzumab

Trastuzumab 8 milligram per kilogram (mg/kg) loading dose, then 6 mg/kg administered via IV infusion on Day 1 of every 21-day cycle.

DRUG

Trastuzumab emtansine

Trastuzumab emtansine 3.6 mg/kg administered via IV infusion on Day 1 of every 21-day cycle. Dose de-escalation may occur for trastuzumab emtansine, from the full trastuzumab emtansine dose at 3.6 mg/kg on Day 1 of every 21-day cycle, potentially to 3.0 mg/kg (Cohort 1C) or 2.4 mg/kg q3w (Cohort 1D).

DRUG

Doxorubicin

Doxorubicin will be administered at 60 mg/m\^2 every 2 weeks as an IV bolus over 3 to 5 minutes or as an infusion over 15 to 30 minutes.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered at 600 mg/m\^2 on Day 1 of each 21 day cycle as an IV bolus over 3 to 5 minutes or as an infusion, in accordance with local policy.

Trial Locations (20)

10461

Montefiore Medical Center, Advanced Women's Health Center, Clinical Trials and Research Unit; Depart, The Bronx

15213

Magee Womens Hospital, Pittsburgh

18015

St. Luke's University Health Network, Bethlehem

19107

Kimmel Cancer Center Thomas Jefferson University, Philadelphia

21287

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

27710

Duke Cancer Center, Durham

28204

Levine Cancer Institute, Charlotte

37203

Tennessee Oncology, Nashville

37404

Tennessee Oncology - Chattanooga; Tennessee Oncology - East Third Street, Chattanooga

38138

West Clinic, Germantown

45242

Oncology Hematology Care Inc, Cincinnati

47905

Horizon Oncology Research, Inc., Lafayette

48201

Karmanos Cancer Center; Department of Oncology, Detroit

53226

Medical College of Wisconsin, Milwaukee

60435

Joliet oncology hematology associates, Joliet

64132

HCA Midwest Division, Kansas City

72205

University of Arkansas for Medical Sciences; Winthrop Rockefeller Cancer Institute, Little Rock

77030

MD Anderson Cancer Center, Houston

78229

Cancer Therapy and Research Center CTRC at UTHSCSA, San Antonio

35294-3300

University of Alabama at Birmingham, Birmingham

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02605915 - Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer | Biotech Hunter | Biotech Hunter