Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

February 1, 2017

Primary Completion Date

July 3, 2023

Study Completion Date

October 24, 2023

Conditions
Hormone Receptor Positive Malignant Neoplasm of BreastHuman Epidermal Growth Factor 2 Negative Carcinoma of BreastEstrogen Receptor Positive Breast CancerProgesterone Receptor Positive TumorMetastatic Breast Cancer
Interventions
DRUG

Palbociclib

Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28.

DRUG

Tamoxifen

Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously).

Trial Locations (7)

17033

Penn State Cancer Institute, Hershey

48910

Michigan State University, Lansing

53188

ProHealth Care, Waukesha

53705

University of Wisconsin, Madison

55455

University of Minnesota, Minneapolis

60612

University of Illinois Cancer Center, Chicago

68198

University of Nebraska Medical Center, Omaha

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

collaborator

Big Ten Cancer Research Consortium

OTHER

lead

Oana Danciu, MD

OTHER