None listed
Conditions
Interventions
Investigational arm Type of group
Ribociclib 400mg by mouth once daily on days 1 to 21 of a 28-day cycle, for 36 months since randomization
AND
Endocrine therapy consisting of:
- For postmenopausal women: letrozole 2.5mg by mouth once daily continuously or anastrozole 1mg by mouth once daily continuously
- For premenopausal women and men: letrozole 2.5mg by mouth once daily continuously or anastrozole 1mg by mouth once daily continuously, combined with goserelin 3.6mg subcutaneously once every 4 weeks. Duration of
Endocrine therapy consisting of:
- For postmenopausal women: letrozole 2.5mg by mouth once daily continuously or anastrozole 1mg by mouth once daily continuously
- For premenopausal women and men: letrozole 2.5mg by mouth once daily continuously or anastrozole 1mg by mouth once daily continuously, combined with goserelin 3.6mg subcutaneously once every 4 weeks. Duration of endocrine therapy in the trial will be 60 months from the randomization
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed and dated Patient Informed Consent Form (PICF) obtained prior to any trial-specific screening procedure. 2. Patient is ≥ 18 years-old at the time of PICF signature. 3. Patient is female with known menopausal status at the time of PICF signature or initiation of adjuvant endocrine therapy (whichever occurs earlier), or male. Postmenopausal status is defined as: - Patient underwent bilateral oophorectomy, or - Age ≥ 60 years, or - Age < 60 years and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen or ovarian suppression) and Follicle-stimulating hormone (FSH) and plasma estradiol are in the postmenopausal ranges per local normal ranges. Note: for women with therapy-induced amenorrhea, serial measurements of FSH and/or estradiol per local clinical guidelines are required for determination of postmenopausal status. All women who do not meet the criteria for postmenopausal status are considered premenopausal for the purpose of this trial. 4. Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis within 18 months prior to randomization. Patient with a multicentric and/or multifocal tumor is eligible if all histopathologically examined lesions meet the pathologic criteria in inclusion criteria 5 and 6. 5. Patient has breast cancer that is positive for estrogen receptor and/or progesterone receptor according to the local laboratory as determined on the most recently analyzed tissue sample. This exclusion criteria your can in the protocol
Exclusion criteria
Exclusion criteria: 1. Patient has received any CDK4/6 inhibitor. 2. Patient has received prior treatment with tamoxifen, raloxifen or aromatase inhibitors for reduction in risk (“chemoprevention”) of breast cancer and/or treatment for osteoporosis within the last 2 years prior to PICF signature. 3. Patient has received prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin, or 900 mg/m² or more for epirubicin. 4. Patient with a known hypersensitivity to any of the excipients of ribociclib and/or endocrine therapy (e.g. rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption, and soy allergy). 5. Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery. This others exclusion cirterian your can find in the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:iDFS using STEEP criteria, as assessed by Investigator Measure:To compare iDFS for ribociclib + endocrine therapy versus endocrine therapy in patients with HR-positive, HER2-negative, EBC Timepoints:3.5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:RFS using STEEP criteria Measure:To evaluate the two treatment arms with respect to recurrence-free survival (RFS) Timepoints:3.5 years ; Outcome name:DDFS using STEEP criteria Measure:To evaluate the two treatment arms with respect to distant disease-free survival (DDFS) Timepoints:3.5 years ; Outcome name:OS defined as time from date of randomization to date of death due to any cause Measure:To evaluate the two treatment arms with respect to overall survival (OS) Timepoints:7.5 years ; Outcome name:Change from baseline in the physical functioning sub-scale score and global helath status/ QoL scale score as assessed by EORTC QLQ-C30 Measure:To evaluate patient reported outcomes (PRO) for health-related quality of life (QoL) in the two treatment arms Timepoints:3.5 years ; Outcome name:PK parameters such as Cmax, Tmax and AUC0-24h for ribociclib Measure:To characterize the PK of Ribociclib when given in combination with NSAI (and goserelin if applicable) Timepoints:3.5 years | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Hungary, Ireland, Italy, Korea North, Poland, Romania, Russian Federation, Spain, Taiwan, United Kindgdom, United States
Contacts
Public ContactFiorella Ramirez
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed