MedTrace Logo

Phase 0 Study of Metronomic Oral Vinorelbine and Letrozole in HR+/HER2-negative Early Breast Cancer Patients (VENTANA)

NCT02802748 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-09-20

No results posted yet for this study

Summary

VENTANA is a "window-of-opportunity" trial that will explore whether, similar to CDK4/6 inhibitors, Oral Metronomic Vinorelbine in combination with Letrozole induces a superior anti-proliferative effect than Letrozole alone.

Conditions

Interventions

DRUG

Oral Vinorelbine

Metronomic Schedule of Vinorelbine administered orally in a schedule monday-wednesday-friday, tuesday-thursday-saturday, etc

DRUG

Letrozole

Letrozole will be administered orally at 2.5 mg QD for 3 weeks.

Sponsors & Collaborators

  • Pierre Fabre Laboratories

    collaborator INDUSTRY

  • SOLTI Breast Cancer Research Group

    lead OTHER

Principal Investigators

  • Aleix Prat, MD, PhD · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • Spain

Study Locations

More Related Trials

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 NCT02802748 on ClinicalTrials.gov