Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

October 25, 2016

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Metastatic Breast Cancer
Interventions
DRUG

Palbociclib

Palbociclib will be given orally, continued at the same dose as was received previously; the maximum starting dose will be per the approved label, a dose of 125 mg once daily. Palbociclib will be taken days 1-21, then seven days off treatment to complete one 28 day cycle.

DRUG

Fulvestrant

Fulvestrant 500 mg should be administered intramuscularly into the buttocks slowly (1-2 minutes per injection) as two 5 mL injections, one in each buttock, on days 1, 15, and 29 (i.e., Cycle 2 Day 1) and once monthly thereafter (i.e., day 1 of each cycle).

Trial Locations (5)

15212

Allegheny Health Network (AHN) - Allegheny General Hospital ONLY, Pittsburgh

19611

Reading Hospital - McGlinn Cancer Institute, West Reading

20016

Kimmel Cancer Center at Johns Hopkins at Sibley Memorial Hospital, Washington D.C.

21287

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

21401

Anne Arundel Health System Research Institute, Inc., Annapolis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

NCT02738866 - Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor | Biotech Hunter | Biotech Hunter