Phase 2
Completed N=222
Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT03839823 ↗Enrolled (actual)
222
Serious AEs
15.6%
Results posted
Sep 2024
Primary outcomePrimary: Progression-free Survival — 21.8; 12.8 months — p=0.003
Summary
To compare the combination of Ribociclib plus goserelin acetate with hormonal therapy versus combination chemotherapy in premenopausal or perimenopausal patients with advanced or metastatic breast cancer
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
21.8; 12.8 | 0.003 sig |
| SECONDARY Time to Treatment Failure |
18.6; 9.1 | — |
| SECONDARY 3-month Treatment Failure Rate |
11.6; 21.8 | 0.020 sig |
| SECONDARY Overall Response Rate (ORR) |
66.1; 61.8 | 0.255 |
| SECONDARY Clinical Benefit Rate |
81.3; 74.5 | 0.116 |
| SECONDARY Time to Response |
4.9; 3.2 | — |
| SECONDARY Overall Survival (OS) |
NA; NA | — |
| SECONDARY Change From Baseline in the Global Health Status/Quality of Life (QOL) Scale Score by Using the Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire |
4.3; 4.8; 5.5; 4.4; 5.9; 4.9 | — |
| SECONDARY Number of Patients With Adverse Events, Categorized by Severity |
112; 100; 71; 62; 18; 11 | — |
| SECONDARY Number of Patients With Laboratory Abnormalities |
82; 73; 5; 11; 0; 0 | — |
| SECONDARY Post-Hoc: All Collected Deaths |
5; 0; 29; 29; 34; 29 | — |
Eligibility Criteria
INCLUSION CRITERIA
- Patient was an adult female ≥ 18 years old and 1.5 ULN.
- Patients with CNS involvement unless they met ALL of the following criteria:
- At least 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment.
- Clinically stable CNS tumor at the time of screening and not receiving steroids and/or enzyme inducing anti-epileptic medications for brain metastases.
- Leptomeningeal metastases was not allowed, even with stable clinical condition.
Data sourced from ClinicalTrials.gov (NCT03839823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.