NCT02549430

To Reverse ENDocrine Resistance Trial - PD 0332991 Monotherapy vs PD 0332991 in Combination With the Endocrine Therapy

Phase 2,Open-label,Multicenter,Randomized Study of PD0332991 (Oral CDK4/6 Inhibitor) Monotherapy and in Combination With the HT to Which the pt Has Progressed in the Previous Line for ER+,Her2- Post-menopausal Advanced Breast Cancer Pts

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Fondazione Sandro Pitigliani · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to assess the activity of PD0332991 in monotherapy and in combination with the endocrine therapy (anastrozole, letrozole, exemestane or fulvestrant) on which the patient has progressed in the previous line for advanced breast cancer in order to reverse endocrine resistance.

Detailed description

In a clinical context, there is a lack of molecular compounds with demonstrated clinical activity in delaying/reversing resistance to endocrine agents. CDK 4/6 inhibitors may represent a biologically-driven option in this context. With the present study investigators aim to complement the ongoing trial on PD0332991 by acquiring information on its clinical activity in post-menopausal patients with ER positive, Her2 negative advanced breast cancer patients already pretreated with a first-line or second line endocrine therapy.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Palbociclib	Palbociclib 125 mg/day orally in an ongoing 3:1 schedule (3 weeks on/1 week off)
DRUG	Anastrozole	Continuation of prior anastrozole 1mg/day orally in a continuous regimen
DRUG	Letrozole	Continuation of prior letrozole 2.5mg/day orally in a continuous regimen
DRUG	Exemestane	Continuation of prior exemestane 25mg/day orally in a continuous regimen
DRUG	Fulvestrant	Continuation of prior fulvestrant 500mg intramuscular injection every 4 weeks in a continuous regimen

Timeline

• Start date: 2012-10-01
• Primary completion: 2017-02-09
• Completion: 2017-02-09
• First posted: 2015-09-15
• Last updated: 2017-08-01

Locations

6 sites across 1 country: Italy