Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05827081 | Phase IIIb Study of Ribociclib + ET in Early Breast Cancer | PHASE3 | RECRUITING | 1,400 | — | — | Feb 28, 2024 | Sep 20, 2030 | Jun 8, 2026 | 217 | United States, Argentina +14 |
| NCT03701334 | A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer | PHASE3 | ACTIVE NOT_RECRUITING | 5,101 | — | — | Dec 7, 2018 | May 29, 2030 | Apr 1, 2026 | 387 | United States, Argentina +18 |
iBCFS is defined as the time from the date of first dose to the date of the first event of invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence, death (any cause), or contralateral invasive BC. iBCFS will be assessed using STEEP criteria version 2.0 (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials), as assessed by Investigator. The iBCFS rate at 3 years will be assessed.
Invasive Disease-Free Survival (iDFS) is defined as the time from the date of randomization to the date of the first event of local invasive breast recurrence, regional invasive recurrence, distant recurrence, death (any cause), contralateral invasive BC, or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin). iDFS will be assessed locally using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials).
| Arm | Type | Description |
|---|---|---|
| Ribociclib + endocrine therapy | EXPERIMENTAL | Participants will receive ribociclib 400 mg orally once daily on days 1 to 21 of a 28-day cycle, in combination with daily endocrine therapy (ET) for 36 months (approximately 39 cycles). ET consists of: * For postmenopausal women: letrozole 2.5 mg orally once daily continuously, anastrozole 1 mg orally once daily continuously, or exemestane 25 mg once daily continuously. * For pre/perimenopausal women, and men: letrozole 2.5 mg orally once daily continuously, anastrozole 1 mg orally once daily continuously, or exemestane 25 mg once daily continuously, combined with goserelin subcutaneously (at 3.6 mg once every 4 weeks if the one-month depot formulation is used or at 10.8 mg once every 3 months if the three-month depot formulation is used) or leuprolide subcutaneously (at 3.75 mg once every 4 weeks if the one-month depot formulation is used or at 11.25 mg once every 3 months if the three-month depot formulation is used) |
| Ribociclib + Endocrine Therapy (ET) | EXPERIMENTAL | Eligible participants will receive Ribociclib 400 mg once daily on days 1 to 21 of a 28-day cycle, followed by 7 days off ribociclib (Days 22 to 28). And Endocrine Therapy (ET) consisting of: * For postmenopausal women: \- Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously. * For premenopausal women and men: * Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously, combined with: * Goserelin 3.6 mg subcutaneously once every 4 weeks. |
| Endocrine Therapy (ET) | ACTIVE_COMPARATOR | Eligible participants will receive Endocrine Therapy (ET) consisting of: * For postmenopausal women: \- Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously. * For premenopausal women and men: * Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously, combined with: * Goserelin 3.6 mg subcutaneously once every 4 weeks. |
| Name | Type | Description |
|---|---|---|
| Ribociclib | DRUG | Ribociclib 400 mg orally once daily on days 1-21 of a 28 day cycle followed by 7 days rest |
| Letrozole | DRUG | Letrozole 2.5 mg orally once daily continuously |
| Ansastrozole | DRUG | Anastrozole 1 mg orally once daily continuously. |
| Goserelin | DRUG | Goserelin administered subcutaneously at 3.6 mg once every 4 weeks if the one-month depot formulation is used or at 10.8 mg once every 3 months if the three-month depot formulation is used |
| Leuprolide | DRUG | Leuprolide administered subcutaneously at 3.75 mg once every 4 weeks if the one-month depot formulation is used or at 11.25 mg once every 3 months if the three-month depot formulation is used |
| Exemestane | DRUG | Exemestane 25 mg once daily continuously |
| Endocrine Therapy (ET) | OTHER | Endocrine Therapy (ET) will be administered according to the local clinical guidelines and current local prescribing information |
Key Inclusion criteria: * Participant is an adult, male or female ≥ 18 years of age at the time of informed consent form signature (IC). * Participant has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer (BC)...