Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

December 20, 2017

Primary Completion Date

July 31, 2026

Study Completion Date

December 31, 2026

Conditions
Breast NeoplasmsBreast Diseases
Interventions
DRUG

Anastrozole

1 mg orally daily, day 1 to day 28

DRUG

Palbociclib

Dose I: 100 mg orally daily, day 1 to day 21, then 7 days off in a 28 day cycle (Phase 1 only) Dose II: 125 mg orally daily, day 1 to day 21, then 7 days off in a 28 day cycle

DRUG

Trastuzumab

8 mg/kg IV initial loading dose, followed by 6 mg/kg IV every 21 days

DRUG

Pertuzumab

840 mg IV followed by a maintenance dose of 420 mg IV every 21 days

Trial Locations (5)

10011

Mount Sinai Beth Israel Comprehensive Cancer Center West, New York

10016

Perlmutter Cancer Center NYU Langone, New York

10019

Mount Sinai West, New York

10032

New York Presbyterian Columbia Irving Comprehensive Cancer Center, New York

10065

New York Presbyterian Weill Cornell Medical Center, New York

All Listed Sponsors
collaborator

Herbert Irving Comprehensive Cancer Center

OTHER

collaborator

Weill Medical College of Cornell University

OTHER

collaborator

NYU Langone Health

OTHER

lead

Icahn School of Medicine at Mount Sinai

OTHER

NCT03304080 - Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast | Biotech Hunter | Biotech Hunter