Hormone receptor-positive, HER2-negative, early breast cancer. MedDRA version: 20.0 Level: LLT Classification code 10006203 Term: Breast cancer stage unspecified System Organ Class: 100000004864 MedDRA version: 20.1 Level: LLT Classification code 10070575 Term: Estrogen receptor positive breast cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Kisqali
Product Name: ribociclib
Product Code: LEE011
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RIBOCICLI
Sponsors
Novartis Farmacéutica S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient is = 18 years-old at the time of PICF signature. - Patient is female with known menopausal status at the time of PICF signature or initiation of adjuvant ET (whichever occurs earlier), or male. - 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 has breast cancer that is positive for ER and/or PgR. - Patient has HER2-negative breast cancer. - Patient has available archival tumor tissue from the surgical specimen. - Patient after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and who belongs to one of the following categories (anatomic stage group II or III). - If indicated, patient has completed adjuvant and/or neoadjuvant chemotherapy according to the institutional guidelines. - If indicated, patient has completed adjuvant radiotherapy according to the institutional guidelines. - Patient has no contraindication for the adjuvant ET in the trial and is planned to be treated with ET for 5 years. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2000
Exclusion criteria
Exclusion criteria: - Patient has received any CDK4/6 inhibitor. - Patient has received prior treatment with tamoxifen, raloxifene or AIs for reduction in risk (“chemoprevention”) of breast cancer and/or treatment for osteoporosis within the last 2 years prior to PICF signature. - 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. - Patient with a known hypersensitivity to any of the excipients of ribociclib and/or ET. - 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. - Patient is concurrently using other anti-neoplastic therapy with the exception of adjuvant ET. - Patient has had major surgery, chemotherapy or radiotherapy within 14 days prior to randomization. - Patient has not recovered from clinical and laboratory acute toxicities related to prior anti-cancer therapies. - Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 2 years before PICF signature. - Patient has known HIV infection, Hepatitis B or C infection. - Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality. - Patient is currently receiving any of the following substances within 7 days before randomization: Concomitant medications, herbal supplements, and/or fruits that are known as strong inhibitors or inducers of CYP3A4/5 or Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5. - Patient is currently receiving or has received systemic corticosteroids = 2 weeks prior to starting trial treatment. - Patient has impairment of GI function or GI disease that may significantly alter the absorption of the oral trial treatments. - Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator’s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol. - Patient participated in another interventional study and received treatment with an investigational product (or used an investigational device) within 30 days prior to randomization or within 5 half-lives of the investigational product, whichever is longer. - Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial. Additional exclusion criteria as per full protocol may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare iDFS for ribociclib + ET versus ET in patients with HRpositive, HER2-negative, EBC.;Primary end point(s): iDFS using STEEP criteria, as assessed by Investigator.;Timepoint(s) of evaluation of this end point: 3.5 years; Secondary Objective: 1. To evaluate the two treatment arms with respect to recurrence-free survival (RFS). 2. To evaluate the two treatment arms with respect to distant diseasefree survival (DDFS). 3. To evaluate the two treatment arms with respect to OS. 4. To evaluate patient reported outcomes (PRO) for health-related quality of life (QoL) in the two treatment arms. 5. To characterize the PK of ribociclib when given in combination with NSAI (and goserelin if applicable). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Recurrence free survival (RFS) using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials). - Distant disease free survival (DDFS) using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials). - Overall survival (OS). - Change from baseline in the physical functioning subscale score and global health status/Quality of life scale score as assessed by EORTC QLQ-C30. - PK parameters such as Cmax, Tmax, and AUC 0- 24h for ribociclib. ; Timepoint(s) of evaluation of this end point: - 3.5 years. - 3.5 years. - 7.5 years. - 3.5 years. - 3.5 years. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Hungary, Ireland, Italy, Korea, Republic of, Peru, Poland, Romania, Russian Federation, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactTMO
Novartis Farmacéutica S.A.
Outcome results
None listed