NCT02585388

Addition of Aromatase at the Navelbine in Pretreated Metastatic Breast Cancer.

A Randomized Phase II, Multicenter Study Evaluating the Benefit of Adding a Non Steroidal Aromatase Inhibitor to Oral Vinorelbine in Patients With Pretreated Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: ARCAGY/ GINECO GROUP · Academic / Other
• Sex: Female
• Age: 50 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The CHEOPS study aims to confirm the clinical benefit of a combination of an anti-aromatase and metronomic chemotherapy treatment

Detailed description

The CHEOPS study aims to confirm the clinical benefit of a combination of an anti-aromatase and metronomic chemotherapy treatment that would have the theoretical advantage of being well tolerated and more effective than chemotherapy alone even after an anti-aromatase therapy.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Vinorelbine	Vinorelbine metronomic at 50 mg (1 tablet at 20 mg and 1 tablet at 30mg),per oral, 3 times per week. One dose level reduction is authorized at 30 mg per day.when stopping over 3 consecutive weeks due to toxicity, treatment should be permanently discontinued
DRUG	Letrozole	Lestrozole at 2,5 mg every day , per oral
DRUG	Anastrozole	Anastrozole at 1 mg every day, per oral

Timeline

• Start date: 2015-10-23
• Primary completion: 2017-05-15
• Completion: 2017-05-15
• First posted: 2015-10-23
• Last updated: 2023-09-06

Locations

47 sites across 1 country: France