NCT03322215

HR+/HER2- Advanced Breast Cancer and Endocrine Resistance

A Phase 2, International, Multicenter, Open-labeled, Randomized Trial of PAlbociclib and Fulvestrant vs. Standard Oral Capecitabine In Patients With Hormone Receptor (HR)+ / HER2- Advanced Breast Cancer and Documented Endocrine Resistance

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Theodoros Foukakis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, 2-arm, open-label, multicenter, international phase II trial. A total of 196 patients will be included. The study will include patients with metastatic Hormone Receptor positive / Human Epidermal Growth Factor Receptor (HER2) negative breast cancer with progressive disease after endocrine treatment. Patients will be randomized (1:1) between two treatment arms: A. palbociclib + fulvestrant and b. capecitabine.

Conditions

• Breast Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Palbociclib	75-125 mg capsule orally once daily for 21 consecutive Days followed by 7 Days of treatment.
DRUG	Fulvestrant	500 mg intramuscularly Days 1 and 15 of cycle 1, and then on Day 1 of each subsequent 28-days cycle.
DRUG	Capecitabine	Oral tablet 500 - 1,250 mg/m2 twice Daily, for 2 weeks followed by 1 week of rest.

Timeline

• Start date: 2017-10-24
• Primary completion: 2021-04-30
• Completion: 2023-10-31
• First posted: 2017-10-26
• Last updated: 2024-03-08

Locations

9 sites across 2 countries: Sweden, United Kingdom

Regulatory

• FDA-regulated drug study