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FACILE: FeAsibility of First-line RiboCIclib in OLdEr Patients with Advanced Breast Cancer

NCT03944434 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2025-02-26

No results posted yet for this study

Summary

Phase II, multicenter, single arm trial to assess the feasibility of first line ribociclib in combination with a non steroidal aromatase inhibitor in women or men aged 70 years-old or older, with hormone receptor positive/HER2 negative advanced breast cancer

Conditions

Interventions

DRUG

Ribociclib

ribociclib 600 mg/day orally

DRUG

Aromatase Inhibitors, non steroideal

letrozole 2.5 mg/day orally or anastrozole 1 mg/day orally

DRUG

LHRH agonist

Triptorelin 3,75 mg or Leuprolide 3,75 mg or goserelin 3,6 mg, as injectable.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Fondazione Sandro Pitigliani

    lead OTHER

Principal Investigators

  • Laura Biganzoli, MD · Hospital of Prato

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-27
Primary Completion
2024-12-27
Completion
2025-11-27

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT03944434 on ClinicalTrials.gov