Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Ribociclib, ribociclib, Ribociclib (neoadjuvant)
LEE011 · 22 trials · 16 indications
PFS is defined as time from randomization to progression of disease or death of any cause, whichever comes first. It will be assessed by imaging until progressive disease or start of next-line therapy.
AEs were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s). SAEs were defined as meeting at least 1 of the following criteria: is fatal or life-threatening, Results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, is medically significant, requires inpatient hospitalization or prolongation of existing hospitalization. A SAE which caused death of the participant was considered as fatal SAE. AEs were assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1 to 5 were used to characterize the severity of the Adverse Event. Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening and Grade 5: death related to AE. A participant with multiple severity grades for an AE is only counted under the maximum grade.
ORR defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR) assessed by local investigators according to RECIST 1.1. CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Progression-free survival was defined as the time from the date of randomization to the date of the first documented progression as per local review and according to RECIST 1.1 or death due to any cause. PFS was censored at the date of the last adequate tumor assessment if no PFS event was observed at the time of last patient, last visit (LPLV).
Progression-free survival (PFS) was defined as the time from randomization to the first documented disease progression or death from any cause. PFS was assessed by local investigators based on tumor evaluations using RECIST version 1.1 criteria. Patients who had not experienced progression or death by the analysis cut-off date of 25 April 2022 were censored at the date of their last adequate tumor assessment prior to that cut-off.
These are the number of participants who had adverse events or serious adverse events regardless of whether is was suspected to be drug-related or not
These are the percentage of participants that had adverse events or serious adverse events regardless of whether is was suspected to be drug-related or not
Continued access to study treatment as a single agent or in combination with other investigational treatments until patients discontinue study
Assessed by duration in days from start of study treatment until study treatment discontinuation
Date of randomization to the date of the first documented progression or death due to any causeas per RECIST v1.1 (by local investigator assessment). Only includes data prior to cross over. Disease progression follow-up: Subjects who discontinued study drug for any reasons other than disease progression were followed for efficacy every 8 weeks during the first 12 months. After 12 months, they were followed for every 12 weeks until disease progression, death, discontinuation from the study for any other reason (i.e. loss to follow-up or withdrawal of consent), the initiation of a new antineoplastic treatment, or until all subjects had been followed for at least 18 months after their first dose of study drug, or early study termination, whichever occurred first.
Clinical benefit (CB) for patients with solid tumors were assessed using RECIST 1.1 and included responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) for ≥ 16 weeks. CR and PR (for solid tumors) required a confirmation at least 4 weeks after the initial response observation. For hematologic tumors other appropriate hematological response criteria was applied. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \<10 mm, PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study, PD=At least a 20% increase in the sum of diameter of all measured target lesions and also demonstrate an absolute increase of at least 5 mm. FAS
CBR was determined by local, Investigator assessment for each tumor assessment and defined as responses of CR + PR + SD for ≥ 16 weeks. CR and PR (for solid tumors) required a confirmation at least 4 weeks after the initial response observation. For hematologic tumors other appropriate hematological response criteria was applied. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \<10 mm, PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study, PD=At least a 20% increase in the sum of diameter of all measured target lesions and also demonstrate an absolute increase of at least 5 mm FAS
ORR was determined by local, Investigator assessment for each tumor assessment and defined as responses of CR+PR ≥ 16 weeks. FAS
Standard 3+3 phase-I design will be utilized in this trial. Briefly, a minimum of 3 evaluable patients will be entered at first dose level (=300 mg ribociclib) and T-DM1 (3.6 mg/kg IV). If 1 out of the first 3 patients enrolled experiences a dose-limiting toxicity (DLT), 3 additional patients will be enrolled to that dose level. If no more than 1 patient in 6 experiences a DLT, dose escalation of ribociclib will continue to next dose-level. If 2 or more patients at any given dose level experience a DLT, dose escalation will stop and the Recommended Phase2 Dose (RP2D) will be defined. Maximum dose-escalation of Ribociclib (LEE011) will be up to 600 mg.
CBR is defined as the proportion of patients with a complete response (CR) or partial response (PR), or with stable disease (SD) at week 24 by RECIST 1.1 criteria. CBR will be reported with 90% confidence interval, adjusting for two-stage design using the method from Atkinson and Brown.
CBR is defined as the proportion of patients with a complete response (CR) or partial response (PR), or with stable disease (SD) at week 24 by RECIST 1.1 criteria. CBR will be reported with 90% confidence interval, adjusting for two-stage design using the method from Atkinson and Brown.
Determine the Recommended Phase II dose (RP2D) of LEE011 (ribociclib) in the combination with everolimus in patients with mPAC refractory to 5-FU- and GEM-based chemotherapy based on DLTs within the first 4 weeks of treatment.
PFS at 8 weeks in a patient with refractory mPAC treated with LEE011 and everolimus, defined as positive if a patient does not have evidence of progressive disease at 8 weeks as measured by expert radiologists using RECIST v1.1 criteria
Determination of MTD and RP2D of ribociclib and capecitabine combination, PO in a 21 day schedule (2 weeks on/1 week off), in subjects eligible to a capecitabine treatment, with locally advanced/metastatic breast cancer who failed anthracycline and taxane treatment.
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as having a reasonably possible relationship to the study medication(s) and is unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment (cycle 1) and meets any of the criteria defined in the protocol. National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 4.03 will be used for all grading.
Clinical Benefit Rate (CBR) is defined as the percentage of participants with a complete response (CR) or partial response (PR) or with stable disease (SD) as per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 or Non-Complete Response or Non-Progressive Disease (NCRNPD) during first 24 weeks of first dose. CR=disappearance of all non-nodal target lesions, PR=at least a 30% decrease in the sum of diameter of all target lesions, SD=neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease (PD), PD=at least a 20% increase in the sum of diameter of all target lesions. The hypothesis was to be rejected if the lower limit of the 95% Confidence Interval for Clinical Benefit Rate (CBR) was greater than 10%.
Complete response (CR) or partial response (PR), or stable disease (SD) at 24 weeks as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Non-CR Non-PD (NCRNPD) at Week 24.
Primary composite PK parameters: Cmax, AUClast, AUCinf, and CL/F. To determine the impact of various degrees of renal impairment on primary PK parameters of LEE011 following a single 400mg oral dose
PK profile includes the following parameters Tmax, Cmax, AUClast, AUCinf, T1/2, CL/F, Vz/F.
DLTs at each dose level associated with administration of LEE011 and letrozole
This will be defined by changes in hematology and chemistry values, vital signs and ECGs, frequency and duration of AEs, lab abnormalities and other safety parameters. For LEE011 and letrozole or tamoxifen or fulvestrant
This will be defined by changes in hematology and chemistry values, vital signs and ECGs, frequency and duration of SAEs, lab abnormalities and other safety parameters. For LEE011 and letrozole or tamoxifen or fulvestrant
Dose Escalation Phase: Frequency of DLTs at each dose level associated with administration of LEE011, buparlisib, and letrozole in a 28 day cycle
Dose Expansion Phase: Incidence of AEs, SAEs (overal and severity), laboratory abnormalities, ECG, vital, dose interteruptions, dose reductions, and dose intensity as a measure of safety and tolerability.
Dose limiting toxicities
Progression Free Survival per RECIST v 1.1 by local investigator assessment
Adverse Events (AEs), serious AEs (SAEs), changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions, reductions and dose intensity.
To characterize PK profiles of LEE011 and Letrozole.
DLT is defined as treatment-related toxicity (classified according Common Toxicity Criteria for Adverse Events (CTCAE) Version 4) occurring during the first 28 treatment days and meeting specific protocol-predefined criteria.
Adverse events were collected for approximately 4.5 years for dose expansion including the 30 days safety follow-up period.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Combination of ribociclib and aromatase inhibitor or fulvestrant |
| Arm B | ACTIVE_COMPARATOR | Capecitabine + bevacizumab OR Paclitaxel +/- bevacizumab |
| Ribociclib + letrozole+goserelin/leuprolide | EXPERIMENTAL | Participants received ribociclib (orally taken, 3 weeks on/1 week off) in combination with letrozole (orally taken once daily). For men and premenopausal women, either goserelin was given as an injectable subcutaneous implant or leuprolide was given as an intramuscular injection. |
| Ribociclib 400 mg | EXPERIMENTAL | Ribociclib 400 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+goserelin in premenopausal women) |
| Ribociclib 600 mg | ACTIVE_COMPARATOR | Ribociclib 600 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+ goserelin in premenopausal women) |
| Combination Chemotherapy | ACTIVE_COMPARATOR | Combination chemotherapies of docetaxel/capecitabine, paclitaxel/gemcitabine or capecitabine/vinorelbine were administered to patients enrolled in the control group. The chemotherapy regimen was decided by the treating physician. |
| Ribociclib | EXPERIMENTAL | Patients in premenopausal and postmenopausal cohorts were randomized in a 1:1 ratio to either the experimental arm or the control arm. Premenopausal experimental arm: Non-steroidal aromatase inhibitor (NSAI) + Goserelin + Ribociclib. For premenopausal patients only, the patient was an adult female who was ≥ 18 years old and \< 60 years old at the time of providing informed consent. The choice of non-steroidal aromatase inhibitor was based on the investigator's assessment of the patient's past medical history. Postmenopausal experimental arm: Letrozole + Ribociclib. Pharmacokinetic (PK) Cohort: Open-label treatment with Ribociclib + Letrozole combination. For postmenopausal patients only, the patient was an adult female who was ≥ 18 years old at the time of providing informed consent. |
| Ribociclib Placebo | PLACEBO_COMPARATOR | Patients in premenopausal and postmenopausal cohorts were randomized in a 1:1 ratio to either the experimental arm or the control arm. Premenopausal control arm: Non-steroidal aromatase inhibitor (NSAI) + Goserelin + Placebo. For premenopausal patients only, the patient was an adult female who was ≥ 18 years old and \< 60 years old at the time of providing informed consent. The choice of non-steroidal aromatase inhibitor was based on the investigator's assessment of the patient's past medical history. Postmenopausal control arm: Letrozole + Placebo. For postmenopausal patients only, the patient was an adult female who was ≥ 18 years old at the time of providing informed consent. |
| Ribociclib + adjuvant endocrine therapy (ET) | EXPERIMENTAL | Patients in this arm took Ribociclib in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen (Tamoxifen no longer permitted after protocol amendment 2) |
| Placebo + adjuvant endocrine therapy (ET) | PLACEBO_COMPARATOR | Patients in this arm took Placebo in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen |
| LEE011 | EXPERIMENTAL | All patients in all combinations with LEE011 will be entered in one arm. |
| Placebo Arm | PLACEBO_COMPARATOR | 600 mg daily dosing days 1-21 of a 28 day cycle |
| Cohort A: Ribociclib + T-DM1 [3+3 Design] | EXPERIMENTAL | * Ribociclib will be given orally once day (day 5-18) at a pre-determine dose for two weeks of a 21 day cycle. During dose escalation, patients received doses of ribociclib of Period 1: 300 mg (n = 3), Period 2: 400 mg (n = 3), Period 3: 500 mg (n = 3), and Period 4: 600 mg (n = 3). Maximum dose-escalation of Ribociclib will be up to 600 mg. Dose-escalation will stop if DLT exceed limit. * T-DM1 will be given as IV infusions on Day 1 of a 3 week cycle at a pre-determined dose over pre-determined period of time. |
| Cohort B: Ribociclib + Trastuzumab [Phase 1b/2 Study] | EXPERIMENTAL | * Ribociclib will be given orally once day (400 mg per day on a continuous schedule) for a 21-day cycle of treatment. * Trastuzumab will be given as IV infusions over 6 mg/kg every 3 weeks. |
| Cohort C: Ribociclib + Trastuzumab + Fulvestrant [Phase 1b/2 Study] | EXPERIMENTAL | * Ribociclib will be given orally once a day continuously for a 28-day cycle of treatment (except at Dose Level -1, when Ribociclib is given Days 1-21 of a 28 day cycle). * Trastuzumab will be given as IV infusions over a pre-determined period of time and dose. Fulvestrant will be dosed approximately every 28 days as per standard of care. |
| Phase I - Dose Level 1 | EXPERIMENTAL | Treatment cycles are 28 days long. LEE011 (taken orally) - 250mg Once daily on days 1-21 Everolimus (taken orally) - 2.5mg Once daily on days 1-28 |
| Phase I - Dose Level 2 | EXPERIMENTAL | Treatment cycles are 28 days long. LEE011 (taken orally) - 300mg Once daily on days 1-21 Everolimus (taken orally) - 2.5mg Once daily on days 1-28 |
| Phase I - Dose Level -1 | EXPERIMENTAL | Treatment cycles are 28 days long. LEE011 (taken orally) - 200mg Once daily on days 1-21 Everolimus (taken orally) - 2.5mg Once daily on days 1-28 |
| Phase I - Dose Level -2 | EXPERIMENTAL | Treatment cycles are 28 days long. LEE011 (taken orally) - 150mg Once daily on days 1-21 Everolimus (taken orally) - 2.5mg Once daily on days 1-28 |
| Phase II - Dose | EXPERIMENTAL | Treatment cycles are 28 days long. LEE011 (taken orally) - the recommended phase II dose Once daily on days 1-21 Everolimus (taken orally) - 2.5mg Once daily on days 1-28 |
| combination of ribociclib + capecitabine | EXPERIMENTAL | RIBOCICLIB from 200 to 600mg once daily + CAPECITABINE from 750 to 1000 mg/m² BID, cycles are defined in 21-day periods, 2 weeks on treatment, 1 week off treatment |
| Cohort A | EXPERIMENTAL | Ribociclib (250 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally for 28 days. If no DLTs occurred, progressed to Cohort B |
| Cohort B | EXPERIMENTAL | Ribociclib (300 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally |
| Cohort C | EXPERIMENTAL | Ribociclib (200 mg daily), everolimus (5 mg daily) and exemestane (25 mg daily) taken orally |
| Group 1 | EXPERIMENTAL | Ribociclib (300 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally |
| Group 2 | EXPERIMENTAL | Ribociclib (200 mg daily), everolimus (5 mg daily) and exemestane (25 mg daily) taken orally |
| Normal renal function | EXPERIMENTAL | Normal renal function; matched demography to renal impariment cohorts |
| Severe renal impairment | EXPERIMENTAL | Severe decrease in GFR (15-29 ml/min) |
| End Stage Renal Disease | EXPERIMENTAL | End stage renal disease not on dialysis; GFR \<15 ml/min |
| Mild renal impairment | EXPERIMENTAL | Mild decrease in GFR (60-89 ml/min) |
| Moderate renal impairment | EXPERIMENTAL | Moderate decrease in GFR (30-59 ml/min) |
| Normal Hepatic Function | EXPERIMENTAL | Normal hepatic function; matched demography to hepatic impairment cohorts |
| Mild Hepatic Impairment | EXPERIMENTAL | Child-Pugh Classification A (score 5-6) |
| Moderate Hepatic Impairment | EXPERIMENTAL | Child-Pugh Classification B (score 7-9) |
| Severe Hepatic Impairment | EXPERIMENTAL | Child-Pugh Classification C (score 10-15) |
| LEE011 +Letrozole | EXPERIMENTAL | LEE011 - 3 weeks on 1 week off Letrozole 2.5mg - Once daily |
| LEE011 + Tamoxifen | EXPERIMENTAL | LEE011 - 3 weeks on 1 week off Tamoxifen 20mg - Once daily |
| LEE011 + Fulvestrant | EXPERIMENTAL | LEE011 - 3 weeks on 1 week off Fulvestrant 500 mg - Dosed every 28 days (Day 1 for each cycle) with 1 additional dose on Day 15 of Cycle 1 |
| LEE011 + buparlisib + letrozole | EXPERIMENTAL | open label, dose escalation evaluating max tolerated dose of the triple combination |
| LEE011 + BKM120 + fulvestrant | EXPERIMENTAL | LEE011 - 28 day cycles (21 days followed by a 7 day break - dose escalating) BKM120 - daily (dose escalating) fulvestrant - i.m. - 500 mg given on day 1 and day 15 of Cycle 1, then on Day 1 of each subsequent cycle. |
| LEE011 + BYL719 + fulvestrant | EXPERIMENTAL | LEE011 - 28 day cycles (21 days followed by a 7 day break - dose escalating) BYL719 - daily (dose escalating) fulvestrant - i.m. - 500 mg given on day 1 and day 15 of Cycle 1, then on Day 1 of each subsequent cycle. |
| LEE011 + letrozole Arm 1 | EXPERIMENTAL | LEE011 - 28 day cycles (21 days followed by a 7 day break - dose escalating), letrozole - 2.5 mg/day |
| BYL719 + letrozole Arm 2 | EXPERIMENTAL | BYL719 - daily (dose escalating) letrozole - 2.5 mg/day |
| LEE011 + BYL719 + letrozole Arm 3 | EXPERIMENTAL | LEE011 - 28 day cycles (21 days followed by a 7 day break -dose escalating), BYL719 - daily (dose escalating), letrozole 2.5 mg/day |
| LEE011+ BYL719+letrozole Arm 4 | EXPERIMENTAL | LEE011-daily (dose escalating), BYL719 -daily (dose escalating), letrozole 2.5 mg/day |
| L-R-E arm | EXPERIMENTAL | Participants who took ribociclib (LEE011), everolimus (RAD001) and exemestane triple combination |
| L-E arm | EXPERIMENTAL | Participants who ribociclib (LEE011) and exemestane double combination |
| Name | Type | Description |
|---|---|---|
| Ribociclib and aromatase inhibitor or fulvestrant | COMBINATION_PRODUCT | Combination of ribociclib and aromatase inhibitor or fulvestrant |
| Capecitabine + bevacizumab OR Paclitaxel +/- bevacizumab | COMBINATION_PRODUCT | Capecitabine with bevacizumab OR Paclitaxel with or without bevacizumab |
| Ribociclib | DRUG | Ribociclib was centrally supplied to the investigators and administered orally once a day on days 1-21 of each 28 day cycle at a starting dose of 600 mg daily |
| Letrozole | DRUG | Letrozole was procured locally and administered orally once a day on a continuous daily schedule at a dose of 2.5 mg |
| Goserelin | DRUG | Goserelin was procured locally and administered in men and premenopausal women as an injectable subcutaneous implant administered on day 1 starting at Cycle 1 and then every 28 days at a dose of 3.6 mg (cycle = 28 days) |
| Leuprolide | DRUG | Leuprolide was procured locally and administered in men and premenopausal women as an injectable intramuscular depot administered on day 1 starting at Cycle 1 and then every 28 days at a dose of 7.5 mg (cycle= 28 days) |
| Anastrozole | DRUG | Anastrozole 1 mg tablets for oral use QD continuously |
| Docetaxel / Capecitabine | COMBINATION_PRODUCT | Docetaxel (IV Infusion) / Capecitabine (Tablets for oral use): Docetaxel once, on day 1 of the 3-weeks cycle. Capecitabine twice daily, on Days 1 to 14, followed by a 1-week rest period, in 3 weeks cycle. Docetaxel (60 - 75 mg/m²)/capecitabine (1600 - 2500 mg/m²/day) |
| Capecitabine / Vinorelbine | COMBINATION_PRODUCT | Capecitabine (Tablets for oral use) / Vinorelbine (Capsule for Oral use/IV infusion ). Capecitabine twice daily on day 1 to 14, followed by a 1-week rest period, in 3 weeks cycle. Vinorelbine, once, on Day 1 and Day 8 in 3 weeks cycles. Capecitabine (1600 - 2500 mg/m2/day)/vinorelbine (60 to 80 mg/m2/day \[oral\] or (25 to 30 mg/m2 \[IV infusion\] |
| Paclitaxel / Gemcitabine | COMBINATION_PRODUCT | Paclitaxel (IV Infusion) / Gemcitabine (IV Infusion): Paclitaxel via 3-hour intravenous (IV) infusion on Day 1 in 3-weeks cycles, OR Paclitaxel via 1 hour intravenous (IV) infusion on Day 1 and day 8- in 3-weeks cycles. Gemcitabine at via 30 minute IV infusion on Day 1 and Day 8 in 3 weeks cycles. Paclitaxel (175 mg/m2) (on Day 1 in 3-weeks cycles)/ gemcitabine (1000 - 1250 mg/m2) OR Paclitaxel (80 - 90 mg/m2) (on Day 1 and Day 8 in 3-weeks cycles) / gemcitabine (800 - 1250 mg/m2) |
| Letrozole OR Anastrozole | DRUG | Letrozole: Dose: 2.5 mg All days of every cycle without interruption). Tablets for oral use Anastrozole: dose: 1 mg All days of every cycle without interruption. Tablets for oral use The NSAI (letrozole or anastrozole) will be decided by the treating physician. |
| Ribociclib Placebo | DRUG | Film-coated tablets for oral use (200 mg x 3) from days 1 to 21 of each 28 day cycle. |
| NSAI: Letrozole or Anastrazole | DRUG | Letrozole: Tablets for oral use, 2.5mg daily (all days of every cycle without interruption). Anastrazole: Tablets for oral use, 1mg daily (all days of every cycle without interruption) For Premenopausal cohort, it is the investigators choice for NSAI based on patients past history. For postmenopausal and PK cohorts, all patients will be on Letrozole. |
| Adjuvant endocrine therapy | DRUG | Letrozole 2.5 mg by mouth daily, or anastrozole 1 mg by mouth daily, exemestane 25 mg by mouth daily, tamoxifen 20 mg by mouth daily, for a total duration of at least 60 months. In premenopausal women, a GnRH agonist administered every 28 days. |
| Placebo | DRUG | Placebo 600 mg daily on days 1 to 21 of a 28-day cycle for 26 cycles (approximately 24 months). Placebo was supplied in the form of 200 mg film-coated tablets taken by mouth. |
| LEE011 | DRUG | Single agent LEE011 or in combination with other treatments |
| LEE011 Placebo | DRUG | - |
| T-DM1 | DRUG | - |
| Trastuzumab | DRUG | - |
| Fulvestrant | DRUG | - |
| Everolimus | DRUG | Treatment cycles are 28 days long. It is taken orally. On all arms, the dosage will be 2.5mg. |
| Combination of ribociclib + capecitabine | DRUG | RIBOCICLIB from 200 to 600mg once daily + CAPECITABINE from 750 to 1000 mg/m² BID, cycles are defined in 21-day periods, 2 weeks on treatment, 1 week off treatment |
| Exemestane | DRUG | supplied in 25 mg tablets taken orally, daily for 28 day cycle |
| Tamoxifen | DRUG | 20 mg |
| Buparlisib | DRUG | daily |
| BYL719 | DRUG | BYL719: supplied as tablets of dosage strength of 10 mg, 50 mg or 200 mg. Tablets will be differentiated through different sizes and/or colors. |
| BKM120 | DRUG | BKM120: supplied as 10 mg or 50 mg capsules. The capsules will be differentiated through different sizes. |
| ribociclib (LEE011) | DRUG | LEE011 is taken orally once per day for 21 days of each 28 day cycle. LEE011 comes in 50 mg and 200 mg capsules. |
| Everolimus (RAD001) | DRUG | Everolimus is taken orally once per day. Everolimus comes in 1 mg, 2.5 mg, 5mg, and 7.5 mg tablets |
Inclusion Criteria: * Age ≥ 18 years. * Any menopausal status. If pre-/perimenopausal, agreement to receive LHRH agonist (goserelin or leuprorelin) / ovarian ablation in case of randomization to arm A * Locally confirmed diagnosis of metastatic adenocarcinoma of the breast without prior systemic an...
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LEE011, also known as ribociclib, is an investigational small molecule being studied for multiple oncology indications, including early breast cancer, hormone receptor positive HER2-negative breast cancer, advanced breast cancer, and glioblastoma multiforme. It is currently in Phase 1 clinical development.
LEE011 (ribociclib) is a cyclin-dependent kinase (CDK) inhibitor, belonging to the -ciclib class of drugs that target CDK enzymes involved in cell cycle regulation. It is being evaluated for its role in treating various cancers, including breast cancer and glioblastoma multiforme.
LEE011 (ribociclib) is developed by Novartis AG, a global pharmaceutical company listed on the stock exchange under the ticker symbol NVS. The drug is being investigated in clinical trials for multiple cancer indications.
LEE011 (ribociclib) is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug has received a rare pediatric disease designation from the FDA.
LEE011 (ribociclib) has been studied in 12 clinical trials with a total enrollment of 6,501 participants. Notable trials include NCT03701334, a Phase 3 study in early breast cancer with 5,101 patients, and NCT05827081, a Phase 3b study in early breast cancer currently recruiting.
Yes, LEE011 is also known as ribociclib. The drug is referred to by both names in clinical research, and it is being developed by Novartis AG for the treatment of various cancers, including breast cancer and glioblastoma multiforme.