Palbociclib in Molecularly Characterized ER-positive/HER2-negative Metastatic Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

August 30, 2016

Primary Completion Date

August 28, 2020

Study Completion Date

December 22, 2022

Conditions
Metastatic Breast Cancer
Interventions
DRUG

Palbociclib

125 mg, orally, daily for 3 weeks followed by 1 week off; repeated at every 28 days cycle until progression, lack of tolerability, or patient declines further protocol treatment.

DRUG

Fulvestrant

500mg, intramuscularly on days 1 and 15 of cycle 1, then on day 1 (+/- 3 days) of every 28 days cycle until progression, lack of tolerability, or patient declines further protocol treatment.

Trial Locations (19)

1000

Institut Jules Bodet, Brussels

1200

Cliniques Universitaires Saint-Luc, Brussels

2610

Sint-Augustinus, Antwerp

2650

Antwerp University Hospital, Edegem

5000

Clinique St. Elizabeth, Namur

13879

Ospedali degli Infermi, S.O.C. Oncologia, Biella

27100

Istituti Clinici Scientifici Maugeri, Medical Oncology Unit, Pavia

Unknown

UZ Leuven, Leuven

CHU Liege, Liège

Ospedale Centrale Bolzano, Medical Oncology, Bolzano

IRCCS San Martino University Hospital, Genova

Mater Salutis Hospital AULSS 21 della Regione Veneto, Legnago

Istituto Europeo di Oncologia, Milan

Azienda USL4 Prato, Prato

Velindre NHS Trust, Cardiff

Western General Hospital, Edinburgh

Beatson West of Scotland Cancer Centre, Glasgow

Singleton Hospital, Swansea

Royal Cornwall, Truro

Sponsors
All Listed Sponsors
collaborator

Breast International Group

OTHER

lead

ETOP IBCSG Partners Foundation

NETWORK

NCT02536742 - Palbociclib in Molecularly Characterized ER-positive/HER2-negative Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter