Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer

Sponsor
GBG Forschungs GmbH
Study ID
NCT03555877
Phase
PHASE2
Status
Completed

Conditions

  • Breast Cancer Metastatic

Eligibility Criteria

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

Interventions

  • Ribociclib — DRUG
    Ribociclib in addition to endocrine maintenance therapy. Endocrine therapy, at the discretion of the investigator, could have already been started up to 4 weeks before randomization but not later than with first dose of ribociclib.
  • Anastrozole — DRUG
    1mg once daily as indicated in the SmPC
  • Letrozole — DRUG
    2,5mg once daily as indicated in the SmPC
  • Exemestane — DRUG
    25mg once daily as indicated in the SmPC
  • Fulvestrant — DRUG
    (prefilled syringes with fulvestrant 250mg each), 500mg given once a month, with an additional 500mg dose given two weeks after the first dose as indicated in the SmPC

Study Details

This is a multicenter, prospective, randomized, open-label, controlled phase II study to test the addition of the CDK4/6 inhibitor ribociclib to anti-hormonal treatment as maintenance therapy in patients with disease control (at least stable disease) after 1st line chemotherapy.

Key Dates

Start date
Mar 15, 2018
Status verified
Jul 2023
Primary completion
Jul 21, 2022
Completion
Jul 21, 2022

Study Design

Enrollment
56 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Anti-hormonal treatment + ribociclib
    In the experimental arm ribociclib will be dosed on a flat scale of 600mg/day (corresponding to three 200mg tablets once daily, 3 week on, one week off). Anti-hormonal/endocrine treatment of choice of investigator: anastrozole, exemestane, letrozole, fulvestrant.
  • Active Comparator: Anti-hormonal treatment
    In the control arm patients will receive endocrine treatment only (of choise of investigator). Anti-hormonal/endocrine treatment of choice of investigator: anastrozole, exemestane, letrozole, fulvestrant.

Primary Outcome Measure

Locally-assessed progression-free survival (PFS) [ Time Frame: Up to 39 months ]

Related Studies