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A Open Study of Metronomic Oral Vinorelbine in Combination With Aromatase Inhibitors for the Treatment of Postmenopausal Women With Hormone Receptor Positive,HER2-negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

NCT02730091 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2021-02-01

No results posted yet for this study

Summary

This study is designed to evaluate the clinical effects of the addition of metronomic oral vinorelbine to letrozole and anastrozole. The study will compare the efficacy and tolerability of oral metronomic vinorelbine administered in combination with letrozole or anastrozole, as treatment for hormone receptor-positive advanced or metastatic breast cancer without resistance to Aromatase Inhibitors (AI).

Conditions

Interventions

DRUG

Letrozole

Letrozole 2.5 mg daily

DRUG

Anastrozole

anastrozole 1 mg daily

DRUG

Vinorelbine

50 mg three times a week (Monday Wednesday and Friday)

Sponsors & Collaborators

  • Pierre Fabre Medicament

    collaborator INDUSTRY

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Principal Investigators

  • Erion DOBI · Centre Hospitalier Universitaire de Besancon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-24
Primary Completion
2020-03-23
Completion
2020-03-23

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02730091 on ClinicalTrials.gov