Biological and Clinical Effects of Palbociclib With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

October 22, 2018

Primary Completion Date

November 30, 2020

Study Completion Date

January 30, 2021

Conditions
Breast Cancer
Interventions
DRUG

Letrozole

Letrozole 2.5 mg by mouth daily for 24 weeks

DRUG

Palbociclib

Palbociclib 125mg by mouth daily for 21 days per 28-day cycle (21 days on, 7 days off) for 24 weeks

DRUG

Goserelin

Goserelin 3.6mg subcutaneous injection x 1 on Day 1 of each 28-day cycle for 24 weeks

DIAGNOSTIC_TEST

Oncotype DX Breast Recurrence Score

Prior to assignment to Arm 1 the Oncotype DX diagnostic test will be conducted on diagnostic tissue to assign a recurrence score for stratification to cohort 1 or 2.

Trial Locations (15)

26506

West Virginia University, Morgantown

53226

Froedtert Hospital, Milwaukee

57105

Avera Cancer Institute-Sioux Falls, Sioux Falls

62526

Cancer Care Specialists of Central Illinois, Decatur

77030

Lester and Sue Smith Breast Center, Houston

90806

Coast Hematology-Oncology Associates Medical Group, Long Beach

Long Beach Memorial Medical Center, Long Beach

Oncology Hematology Consultants, Long Beach

92653

Saddleback Memorial Medical Center, Laguna Hills

92708

Breast Cancer Care Specialist, Fountain Valley

Orange Coast Blood and Cancer Care, Fountain Valley

H2X-3E4

Centre Hospitalier de l'Universite de Montreal, Montreal

H3T 1E2

Jewish General Hospital - Montreal, Montreal

H4A 3J1

McGill University Health Centre-Cedars Cancer Centre, Montreal

G1S 4L8

CHU de Quebec - Hopital de Saint-Sacrement, Québec

Sponsors
All Listed Sponsors
collaborator

Genomic Health®, Inc.

INDUSTRY

collaborator

Pfizer

INDUSTRY

lead

NSABP Foundation Inc

NETWORK

NCT03628066 - Biological and Clinical Effects of Palbociclib With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Breast Cancer | Biotech Hunter | Biotech Hunter