Phase 3
N=672
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
Advanced Metastatic Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02278120 ↗Enrolled (actual)
672
Serious AEs
19.0%
Results posted
Feb 2019
Primary outcome: Primary: Progression Free Survival (PFS) by Investigator Assessment — 23.8; 13.0 Months — p=<0.0000001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ribociclib (Drug); Tamoxifen (Drug); Letrozole (Drug); Anastrozole (Drug); Goserelin (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) by Investigator Assessment |
23.8; 13.0 | <0.0000001 sig |
| SECONDARY Overall Survival (OS) |
NA; 40.9 | 0.00973 sig |
| SECONDARY Overall Response Rate (ORR) by Investigator Assessment |
40.9; 29.7 | 0.000980 sig |
| SECONDARY Clinical Benefit Rate (CBR) by Investigator Assessment |
79.1; 69.7 | 0.002 sig |
| SECONDARY Time to Response (TTR) by Investigator Assessment |
NA; NA | — |
| SECONDARY Duration of Response (DOR) by Investigator Assessment |
21.3; 17.5 | — |
| SECONDARY Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least One Category of the Score |
NA; NA | — |
| SECONDARY Time to Definitive 10% Deterioration in the Global Health Status/Quality of Life (GHS/QoL) Scale Score of the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30) |
NA; 21.2 | — |
| SECONDARY Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30 |
4.6; 5.0; 5.1; 5.1; 5.0; 4.0 | — |
Summary
The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a NSAI + goserelin + placebo in premenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.
Eligibility Criteria
Key inclusion criteria
- Patients had advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy
- Patients were premenopausal or perimenopausal at the time of study entry
- Patients who had received (neo) adjuvant therapy for breast cancer were eligible
- Patients had a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer
- Patients had HER2-negative breast cancer
- Patients must have either had measurable disease or If no measurable disease was present, then at least one predominantly lytic bone lesion
- Patients had an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Patients had adequate bone marrow and organ function
Key exclusion criteria
- Patients who had received a prior CDK4/6 inhibitor
- Patients were postmenopausal
- Patients who currently had inflammatory breast cancer at screening.
- Patients who had received any prior hormonal anti-cancer therapy for advanced breast cancer, except for ≤ 14 days of tamoxifen or NSAI ± goserelin for advanced breast cancer prior to randomization.
- Patients had a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated basal cell skin carcinoma, squamous cell skin carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
- Patients with CNS metastases.
- Patients had active cardiac disease or a history of cardiac dysfunction
- Patients were currently using other antineoplastic agents
- Patients were pregnant or nursing or physiologically capable of becoming pregnant and not using highly effective contraception.
Data sourced from ClinicalTrials.gov (NCT02278120). 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.