Fulvestrant Versus Fulvestrant Plus Palbociclib in Operable Breast Cancer Responding to Fulvestrant

PHASE3CompletedINTERVENTIONAL
Enrollment

354

Participants

Timeline

Start Date

December 20, 2017

Primary Completion Date

April 12, 2021

Study Completion Date

July 20, 2021

Conditions
Breast Neoplasm Female
Interventions
DRUG

Fulvestrant 500mg

All patients in all arms will receive Fulvestrant 500mg

DRUG

Palbociclib 125mg

Dose reduction to 100 mg and 75 mg

DRUG

Goserelin 3.6 MG

Only for pre or peri menopausal patient

DRUG

Placebos

Placebo

Trial Locations (14)

Unknown

Center Pierre et Marie Curie, Algiers

Cancer Center - Blida, Blida

CHU - Oran, Oran

University of Alexandria, Alexandria

National Cancer Institut (NCI), Cairo

King Hussein Cancer Center (KHCC) - Amman, Amman

Hotel Dieu de France, Beirut

Hopital Cheikh Khalifa Ibn Zaid, Casablanca

Department of Oncology - Institut National d'Oncologie, Rabat

King Abdul Aziz Medical City-National Guard Health Affairs (NGHA), Riyadh

Oncology Center- King Fahad Medical City (KFMC), Riyadh

Oncology Center- King Saud University Medical City (KSUMC), Riyadh

Oncologie Medicale de l'Ariana (SOMA), Tunis

Tawam Hospital, Al Ain City

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

collaborator

Pfizer

INDUSTRY

collaborator

Genomic Health®, Inc.

INDUSTRY

lead

International Cancer Research Group, United Arab Emirates

OTHER