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

Sponsor
Fondazione Sandro Pitigliani
Study ID
NCT03944434
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ribociclib — DRUG
    ribociclib 600 mg/day orally
  • Aromatase Inhibitors, non steroideal — DRUG
    letrozole 2.5 mg/day orally or anastrozole 1 mg/day orally
  • LHRH agonist — DRUG
    Triptorelin 3,75 mg or Leuprolide 3,75 mg or goserelin 3,6 mg, as injectable.

Study Details

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

Key Dates

Start date
Dec 27, 2018
Status verified
Feb 2025
Primary completion
Dec 27, 2024
Completion
Nov 27, 2025

Study Design

Enrollment
116 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: single arm
    patients will receive anastrozole tablets (1 mg once daily) or letrozole tablets (2.5 mg once daily) + ribociclib tablets (600 mg day 1 to 21 in a 28 day cycle). Courses repeat every 28 days in the absence of disease progression, unacceptable toxicity, physician's decision, patient's refusal/consent withdrawal, or lost to follow-up. A LHRH agonist (triptorelin 3,75 mg or leuprolide 3,75 mg or goserelin 3,6 mg, as injectable intramuscular (i.m.) or subcutaneous (s.c.) implant every 28 days) will be used in men.

Primary Outcome Measure

Treatment feasibility [ Time Frame: 6 months ]

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