T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

December 6, 2018

Primary Completion Date

December 22, 2022

Study Completion Date

December 22, 2022

Conditions
HER2-positive Breast CancerBreast CancerBreast Cancer StageRecurrent Breast CancerMetastatic Breast CancerHER2 Positive Breast Carcinoma
Interventions
DRUG

Palbociclib

Palbociclib is to be taken orally on days 5-18 (14 days) of each cycle (each cycle length is 21 days). The starting dose will be 125mg.

DRUG

T-DM1

The recommended dose of T-DM1 is 3.6 mg/kg and is given as an intravenous infusion on Day 1 of every cycle (every 21 days).

Trial Locations (16)

14263

Roswell Park Comprehensive Cancer center, Buffalo

19107

Thomas Jefferson University Hospital, Philadelphia

21287

Johns Hopkins Hospital, Baltimore

27599

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

44195

Cleveland Clinic, Cleveland

53706

University of Wisconsin, Madison

65406

Mosaic Life Care, Saint Joseph

76104

JPS Health Network, Fort Worth

80045

University of Colorado Denver, Aurora

85724

University of Arizona Cancer Center, Tucson

87131

University of New Mexico, Albuquerque

90048

Cedar-Sinai, Beverly Hills

97239

Oregon Health and Sciences University, Portland

98104

Swedish Cancer Institute, Seattle

98195

University of Washington, Seattle

06519

Yale Cancer Center, New Haven

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

University of Arizona

OTHER