NCT01864746 - A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery | Biotech Hunter

Enrollment

1,250

Participants

Timeline

Start Date

October 30, 2013

Primary Completion Date

August 24, 2020

Study Completion Date

December 21, 2020

Conditions

Breast CancerHormonreceptor PositiveHer2-normalPostneoadjuvant Treatment With CDK 4/6 InhibitorCPS-EG Score

Interventions

DRUG

Palbociclib PD-0332991

palbociclib at a dose of 125 mg once daily, day 1 to day 21 followed by 7 days off treatment in a 28-day cycle

DRUG

Placebo

Arm B: Placebo of palbociclib once daily day 1 to day 21 followed by 7 days off treatment in a 28-day cycle for thirteen cycles

Trial Locations (11)

Contact: Cancer Trials Ireland, Dublin

Contact: Austrian Breast & Colorectal Cancer Study Group, Vienna

NSABP Foundation, Pittsburgh

GEICAM, San Sebastián de los Reyes

Contact: German Breast Group, Neu-Isenburg

Contact: UNICANCER, Paris

Contact: Australia and New Zealand Breast Cancer Trials Group, Newcastle

Contact: NSABP Foundation, Multiple Locations

Contact: Japan Breast Cancer Research Group, Tokyo

Contact: Korea Cancer Study Group, Seoul

Contact: Institute of Cancer Research, London