Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients

Sponsor
Institut fuer Frauengesundheit
Study ID
NCT05452213
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Breast Cancer
  • Breast Cancer
  • Breast Cancer Female
  • Breast Neoplasm Female
  • Breast Neoplasms
  • HER2-negative Breast Cancer
  • Hormone Receptor-positive Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ribociclib — DRUG
    All patients will receive ribociclib in combination with standard endocrine therapy according to the current SmPC and local in-house standard. Ribociclib will be administered once daily for 21 consecutive days followed by 7 days off treatment (28-day cycle). The daily dose is 600 mg/day. Ribociclib and standard of care endocrine treatment will be prescribed and administered according to investigator's discretion.

Study Details

This is a single-arm, open-label phase IV study of patients with advanced HR+/HER2- breast cancer who are treated first line with ribociclib and standard of care endocrine treatment according to SmPC.

Key Dates

Start date
Oct 12, 2022
Status verified
Apr 2023
Primary completion
Oct 31, 2024
Completion
Oct 31, 2026

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ribociclib

Primary Outcome Measure

12-month PFS rate [ Time Frame: 12 months ]

Central Contacts

Related Studies