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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001931-36 | EudraCT Number |
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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.
This was a randomized, Phase III, double-blind, global study comparing the treatment efficacy and safety of ribociclib + goserelin + tamoxifen or a NSAI (letrozole or anastrozole) versus placebo + goserelin + tamoxifen or a NSAI in premenopausal women with HR+, HER2- advanced breast cancer.
Eligible participants were randomized in a 1:1 ratio to either the ribociclib arm or the placebo arm. Study treatment continued until disease progression, unacceptable toxicity, death, or discontinuation for any other reason.
Participants who discontinued treatment due to reasons other than disease progression or withdrawal of consent for efficacy follow-up continued to be monitored until disease progression, death, withdrawal of consent, loss to follow-up, or subject/guardian decision (post-treatment efficacy follow-up).
All participants who discontinued treatment were followed for survival until the predetermined number of overall survival (OS) events was reached.
Following the final OS analysis (performed when approximately 189 deaths were recorded) and with protocol amendment 6 (dated 18-Jul-2019), participants and investigators were unblinded and those participants in the placebo arm had the opportunity to cross-over to the ribociclib arm to receive ribociclib + goserelin + NSAI. Cross-over was optional and was conducted at the investigator's discretion and upon participant consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ribociclib + NSAI/tamoxifen + goserelin | Experimental | Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days) |
|
| Placebo + NSAI/tamoxifen + goserelin | Placebo Comparator | Placebo daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days). Participants were unblinded once the final OS analysis was conducted and after the implementation of protocol amendment 6 (16-Jul-2019) and were given the option to crossover to treatment with ribociclib +NSAI/tamoxifen + goserelin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ribociclib | Drug | Ribociclib (600 mg, in three 200 mg hard gelatin capsules) was administered orally once daily on Days 1-21 of each 28-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) by Investigator Assessment | PFS was defined as the period starting from the date of randomization to the date of the first documented progression or death caused by any reason. In cases where patients did not experience an event, the PFS was censored at the date of the last adequate tumor assessment. Clinical deterioration without objective radiological evidence was not considered as documented disease progression. PFS was assessed via local radiology assessment according to RECIST 1.1. As per protocol, the final PFS analysis was conducted after approximately 392 PFS events were documented. The Kaplan-Meier method was used to estimate PFS, and the median PFS, along with 95% confidence intervals, was reported for each treatment group. A stratified Cox regression model was used to estimate the hazard ratio of PFS, along with 95% confidence interval | From randomization to first documented progression or death, assessed up to approximately 29 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death from any cause. In cases where the patient's death was not recorded, the OS value was censored at the date of the last known patient's survival status. OS was estimated using the Kaplan-Meier method. As per protocol, the final OS analysis was conducted after approximately 189 deaths were documented. The median OS, along with 95% confidence intervals, was reported for each treatment group.The distribution of OS between the two treatment arms was compared using a log-rank test at one-sided cumulative 2.5% level of significance. A stratified Cox regression was used to estimate the OS hazard ratio and the associated 95% CI. |
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Key inclusion criteria:
Key exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Blood and Cancer SC-2 | Bakersfield | California | 93309 | United States | ||
| University Of California Los Angeles Dept of Onc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42334791 | Derived | Ji Y, Wang C, Combes FP, Ho YY, Fasching PA, Untch M, Zarate JP, Crown J. Quantitative Pharmacology Justifying Ribociclib Dose in Early Breast Cancer. Clin Pharmacokinet. 2026 Jun 23. doi: 10.1007/s40262-026-01643-3. Online ahead of print. | |
| 39826197 | Derived | Hart LL, Im SA, Tolaney SM, Campone M, Pluard T, Sousa B, Freyer G, Decker T, Kalinsky K, Sopher G, Gao M, Hu H, Kuemmel S. Efficacy, safety, and patient-reported outcomes across young to older age groups of patients with HR+/HER2- advanced breast cancer treated with ribociclib plus endocrine therapy in the randomized MONALEESA-2, -3, and -7 trials. Eur J Cancer. 2025 Feb 25;217:115225. doi: 10.1016/j.ejca.2025.115225. Epub 2025 Jan 8. |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Screening assessments were conducted up to 28 days prior to the randomization
Participants were enrolled in 185 sites across 30 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ribociclib + NSAI/Tamoxifen + Goserelin | Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days) |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 24, 2020 | Feb 13, 2024 |
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| Tamoxifen | Drug | Tamoxifen (20 mg, tablets) was administered orally on a continuous daily schedule (days 1-28 of each 28-day cycle) |
|
| Letrozole | Drug | Letrozole (2.5 mg, tablets) was administered orally once daily on a continuous daily schedule (days 1-28 of each 28-day cycle) |
|
| Anastrozole | Drug | Anastrozole (1 mg, tablets) was administered orally once daily on a continuous daily schedule (days 1-28 of each 28-day cycle) |
|
| Goserelin | Drug | Goserelin (3.6 mg, subcutaneous implant) was administered on day 1 of every 28-day cycle |
|
| Placebo | Drug | Placebo (hard gelatin capsules) was administered orally once daily on Days 1-21 of each 28-day cycle. |
|
| From randomization to death, assessed up to approximately 45 months |
| Overall Response Rate (ORR) by Investigator Assessment | ORR is the percentage of participants with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 as per local assessment. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 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. | Up to approximately 29 months |
| Clinical Benefit Rate (CBR) by Investigator Assessment | Percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) lasting 24 weeks or longer as defined in RECIST 1.1 and local assessment. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 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; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease: PD = At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20% the sum must also demonstrate an absolute increase of at least 5 mm. | Up to approximately 29 months |
| Time to Response (TTR) by Investigator Assessment | Time to response is the time from the date of randomization to the first documented response (CR or PR, which must be confirmed subsequently) according to RECIST 1.1 as per local assessment. The Kaplan-Meier method was used to estimate TTR, and the median TTR, along with 95% confidence intervals, was reported for each treatment group. Participants who did not achieve a confirmed response were censored at the maximum follow-up time for patients who had a PFS event (i.e. either progressed or died due to any cause) or at the date of last adequate tumor assessment otherwise. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 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. | Up to approximately 29 months |
| Duration of Response (DOR) by Investigator Assessment | DOR was defined as the time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer as defined in RECIST 1.1 per investigator assessment. The Kaplan-Meier method was used to estimate DOR, and the median DOR, along with 95% confidence intervals, was reported for each treatment group. If a participant had not had an event, duration was censored at the date of last adequate tumor assessment. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 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. | Up to approximately 29 months |
| Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least One Category of the Score | ECOG PS categorized patients based on their ability to perform daily activities and self-care, with scores ranging from 0 to 5. A score of 0 indicated no restrictions in activity, while higher scores indicated increasing limitations. Time to definitive deterioration was defined as the time from the date of randomization to the date of the event, defined as experiencing an increase in ECOG PS by at least one category from the baseline or death. A deterioration was considered definitive if no improvements in the ECOG PS were observed at a subsequent time. The Kaplan-Meier method was used to estimate the distribution, and the median time to definitive deterioration, along with 95% confidence intervals, was reported for each treatment group. Patients receiving any further therapy prior to definitive worsening were censored at their date of last assessment prior to start of therapy. Patients that had not worsened at the data cutoff point were censored at the date of last assessment. | Baseline, up to approximately 29 months |
| 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) | The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The time to definitive 10% deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10% relative to baseline worsening of the QoL score (without further improvement above the threshold) or death due to any cause. The Kaplan-Meier method was used to estimate the distribution, and the median time to definitive 10% deterioration, along with 95% confidence intervals, was reported for each treatment group. If a patient had not had an event, time to deterioration was censored at the date of the last adequate QoL evaluation. | Up to approximately 29 months |
| Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30 | The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The change from baseline in the GHS/QoL score was assessed. A positive change from baseline indicated improvement. For subjects who discontinued treatment without disease progression, post-treatment efficacy visits occurred every 8 weeks during the initial 18 months since start of treatment, followed by visits every 12 weeks until disease progression. | Baseline, every 2 cycles after randomization during 18 months, then every 3 cycles up to end of treatment (EOT); EOT; and every 8 or 12 weeks post-treatment until progression, assessed up to approximately 29 months. Cycle=28 days |
| Los Angeles |
| California |
| 90095 |
| United States |
| Comprehensive Cancer Center at Saint Joseph Hospital SC | Denver | Colorado | 80218 | United States |
| Danbury Hospital SC | Danbury | Connecticut | 06810 | United States |
| Florida Cancer Specialists Onc Dept | Fort Myers | Florida | 33901 | United States |
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| Moanalua Medical Center. Attn: Oncology Dept SC | Honolulu | Hawaii | 96817 | United States |
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| Sidney Kimmel CCC At JH Dept of Onc. | Baltimore | Maryland | 21231 | United States |
| Massachusetts General Hospital Onc Dept | Boston | Massachusetts | 02114 | United States |
| University of Michigan Comprehensive Cancer Center Onc Dept | Ann Arbor | Michigan | 48109 | United States |
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| The Center for Cancer and Blood Disorders SC | Fort Worth | Texas | 76104 | United States |
| Methodist Hospita Methodist Can Cen Dept of Oncology | Houston | Texas | 77030 | United States |
| Uni of TX MD Anderson Cancer Cntr SC-5 | Houston | Texas | 77030 | United States |
| Mays Cancer Ctr Uthsa Mdacc SC-4 | San Antonio | Texas | 78229 | United States |
| Brooke Army Medical Center SC | San Antonio | Texas | 78234 | United States |
| Northern Utah Cancer Associates | Ogden | Utah | 84403-3105 | United States |
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| Providence Regional Cancer Partnership | Everett | Washington | 98201 | United States |
| Kadlec Clinic Hematology and Onco Kadlec Clinic Hematology & Onc | Kennewick | Washington | 99336 | United States |
| Northwest Medical Specialties Dept of Onc | Tacoma | Washington | 98405 | United States |
| University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3 | Madison | Wisconsin | 53792-6164 | United States |
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| 37673211 | Derived | Andre F, Su F, Solovieff N, Hortobagyi G, Chia S, Neven P, Bardia A, Tripathy D, Lu YS, Lteif A, Taran T, Babbar N, Slamon D, Arteaga CL. Pooled ctDNA analysis of MONALEESA phase III advanced breast cancer trials. Ann Oncol. 2023 Nov;34(11):1003-1014. doi: 10.1016/j.annonc.2023.08.011. Epub 2023 Sep 5. |
| 36800111 | Derived | Ji Y, Yartsev V, Quinlan M, Serra P, Wang Y, Chakraborty A, Miller M. Justifying Ribociclib Dose in Patients with Advanced Breast Cancer with Renal Impairment Based on PK, Safety, and Efficacy Data: An Innovative Approach Integrating Data from a Dedicated Renal Impairment Study and Oncology Clinical Trials. Clin Pharmacokinet. 2023 Mar;62(3):493-504. doi: 10.1007/s40262-022-01206-2. Epub 2023 Feb 17. |
| 34965945 | Derived | Lu YS, Im SA, Colleoni M, Franke F, Bardia A, Cardoso F, Harbeck N, Hurvitz S, Chow L, Sohn J, Lee KS, Campos-Gomez S, Villanueva Vazquez R, Jung KH, Babu KG, Wheatley-Price P, De Laurentiis M, Im YH, Kuemmel S, El-Saghir N, O'Regan R, Gasch C, Solovieff N, Wang C, Wang Y, Chakravartty A, Ji Y, Tripathy D. Updated Overall Survival of Ribociclib plus Endocrine Therapy versus Endocrine Therapy Alone in Pre- and Perimenopausal Patients with HR+/HER2- Advanced Breast Cancer in MONALEESA-7: A Phase III Randomized Clinical Trial. Clin Cancer Res. 2022 Mar 1;28(5):851-859. doi: 10.1158/1078-0432.CCR-21-3032. |
| 34504990 | Derived | Bardia A, Su F, Solovieff N, Im SA, Sohn J, Lee KS, Campos-Gomez S, Jung KH, Colleoni M, Vazquez RV, Franke F, Hurvitz S, Harbeck N, Chow L, Taran T, Rodriguez Lorenc K, Babbar N, Tripathy D, Lu YS. Genomic Profiling of Premenopausal HR+ and HER2- Metastatic Breast Cancer by Circulating Tumor DNA and Association of Genetic Alterations With Therapeutic Response to Endocrine Therapy and Ribociclib. JCO Precis Oncol. 2021 Sep 1;5:PO.20.00445. doi: 10.1200/PO.20.00445. eCollection 2021. |
| 34158598 | Derived | Burris HA, Chan A, Bardia A, Thaddeus Beck J, Sohn J, Neven P, Tripathy D, Im SA, Chia S, Esteva FJ, Hart L, Zarate JP, Ridolfi A, Lorenc KR, Yardley DA. Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer. Br J Cancer. 2021 Aug;125(5):679-686. doi: 10.1038/s41416-021-01415-9. Epub 2021 Jun 22. |
| 33769862 | Derived | Prat A, Chaudhury A, Solovieff N, Pare L, Martinez D, Chic N, Martinez-Saez O, Braso-Maristany F, Lteif A, Taran T, Babbar N, Su F. Correlative Biomarker Analysis of Intrinsic Subtypes and Efficacy Across the MONALEESA Phase III Studies. J Clin Oncol. 2021 May 1;39(13):1458-1467. doi: 10.1200/JCO.20.02977. Epub 2021 Mar 26. |
| 31305131 | Derived | Yardley DA. MONALEESA clinical program: a review of ribociclib use in different clinical settings. Future Oncol. 2019 Aug;15(23):2673-2686. doi: 10.2217/fon-2019-0130. Epub 2019 Jul 15. |
| 31166679 | Derived | Im SA, Lu YS, Bardia A, Harbeck N, Colleoni M, Franke F, Chow L, Sohn J, Lee KS, Campos-Gomez S, Villanueva-Vazquez R, Jung KH, Chakravartty A, Hughes G, Gounaris I, Rodriguez-Lorenc K, Taran T, Hurvitz S, Tripathy D. Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer. N Engl J Med. 2019 Jul 25;381(4):307-316. doi: 10.1056/NEJMoa1903765. Epub 2019 Jun 4. |
| 29804902 | Derived | Tripathy D, Im SA, Colleoni M, Franke F, Bardia A, Harbeck N, Hurvitz SA, Chow L, Sohn J, Lee KS, Campos-Gomez S, Villanueva Vazquez R, Jung KH, Babu KG, Wheatley-Price P, De Laurentiis M, Im YH, Kuemmel S, El-Saghir N, Liu MC, Carlson G, Hughes G, Diaz-Padilla I, Germa C, Hirawat S, Lu YS. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol. 2018 Jul;19(7):904-915. doi: 10.1016/S1470-2045(18)30292-4. Epub 2018 May 24. |
| Placebo + NSAI/Tamoxifen+ Goserelin |
Placebo daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days). Participants were unblinded once the final OS analysis was conducted and after the implementation of protocol amendment 6 (16-Jul-2019) and were given the option to crossover to treatment with ribociclib +NSAI/tamoxifen + goserelin |
| Crossover Cohort | Participants in the placebo arm who crossed over to the ribociclib arm and received at least one dose of the crossover study treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Post-treatment Efficacy Follow-up |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ribociclib + NSAI/Tamoxifen + Goserelin | Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days) |
| BG001 | Placebo + NSAI/Tamoxifen+ Goserelin | Placebo daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days). Participants were unblinded once the final OS analysis was conducted and after the implementation of protocol amendment 6 (16-Jul-2019) and were given the option to crossover to treatment with ribociclib +NSAI/tamoxifen + goserelin |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) by Investigator Assessment | PFS was defined as the period starting from the date of randomization to the date of the first documented progression or death caused by any reason. In cases where patients did not experience an event, the PFS was censored at the date of the last adequate tumor assessment. Clinical deterioration without objective radiological evidence was not considered as documented disease progression. PFS was assessed via local radiology assessment according to RECIST 1.1. As per protocol, the final PFS analysis was conducted after approximately 392 PFS events were documented. The Kaplan-Meier method was used to estimate PFS, and the median PFS, along with 95% confidence intervals, was reported for each treatment group. A stratified Cox regression model was used to estimate the hazard ratio of PFS, along with 95% confidence interval | The Full Analysis Set (FAS) including all randomized patients. | Posted | Median | 95% Confidence Interval | Months | From randomization to first documented progression or death, assessed up to approximately 29 months |
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| Secondary | Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death from any cause. In cases where the patient's death was not recorded, the OS value was censored at the date of the last known patient's survival status. OS was estimated using the Kaplan-Meier method. As per protocol, the final OS analysis was conducted after approximately 189 deaths were documented. The median OS, along with 95% confidence intervals, was reported for each treatment group.The distribution of OS between the two treatment arms was compared using a log-rank test at one-sided cumulative 2.5% level of significance. A stratified Cox regression was used to estimate the OS hazard ratio and the associated 95% CI. | FAS including all randomized participants | Posted | Median | 95% Confidence Interval | Months | From randomization to death, assessed up to approximately 45 months |
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| Secondary | Overall Response Rate (ORR) by Investigator Assessment | ORR is the percentage of participants with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 as per local assessment. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 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. | FAS including all randomized participants | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 29 months |
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| Secondary | Clinical Benefit Rate (CBR) by Investigator Assessment | Percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) lasting 24 weeks or longer as defined in RECIST 1.1 and local assessment. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 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; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease: PD = At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20% the sum must also demonstrate an absolute increase of at least 5 mm. | FAS including all randomized participants | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 29 months |
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| Secondary | Time to Response (TTR) by Investigator Assessment | Time to response is the time from the date of randomization to the first documented response (CR or PR, which must be confirmed subsequently) according to RECIST 1.1 as per local assessment. The Kaplan-Meier method was used to estimate TTR, and the median TTR, along with 95% confidence intervals, was reported for each treatment group. Participants who did not achieve a confirmed response were censored at the maximum follow-up time for patients who had a PFS event (i.e. either progressed or died due to any cause) or at the date of last adequate tumor assessment otherwise. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 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. | FAS including all randomized participants | Posted | Median | 95% Confidence Interval | months | Up to approximately 29 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) by Investigator Assessment | DOR was defined as the time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer as defined in RECIST 1.1 per investigator assessment. The Kaplan-Meier method was used to estimate DOR, and the median DOR, along with 95% confidence intervals, was reported for each treatment group. If a participant had not had an event, duration was censored at the date of last adequate tumor assessment. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 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. | Randomized participants with confirmed CR or PR as per investigator assessment | Posted | Median | 95% Confidence Interval | Months | Up to approximately 29 months |
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| Secondary | Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least One Category of the Score | ECOG PS categorized patients based on their ability to perform daily activities and self-care, with scores ranging from 0 to 5. A score of 0 indicated no restrictions in activity, while higher scores indicated increasing limitations. Time to definitive deterioration was defined as the time from the date of randomization to the date of the event, defined as experiencing an increase in ECOG PS by at least one category from the baseline or death. A deterioration was considered definitive if no improvements in the ECOG PS were observed at a subsequent time. The Kaplan-Meier method was used to estimate the distribution, and the median time to definitive deterioration, along with 95% confidence intervals, was reported for each treatment group. Patients receiving any further therapy prior to definitive worsening were censored at their date of last assessment prior to start of therapy. Patients that had not worsened at the data cutoff point were censored at the date of last assessment. | FAS including all randomized participants | Posted | Median | 95% Confidence Interval | Months | Baseline, up to approximately 29 months |
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| 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) | The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The time to definitive 10% deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10% relative to baseline worsening of the QoL score (without further improvement above the threshold) or death due to any cause. The Kaplan-Meier method was used to estimate the distribution, and the median time to definitive 10% deterioration, along with 95% confidence intervals, was reported for each treatment group. If a patient had not had an event, time to deterioration was censored at the date of the last adequate QoL evaluation. | FAS including all randomized participants | Posted | Median | 95% Confidence Interval | Months | Up to approximately 29 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30 | The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The change from baseline in the GHS/QoL score was assessed. A positive change from baseline indicated improvement. For subjects who discontinued treatment without disease progression, post-treatment efficacy visits occurred every 8 weeks during the initial 18 months since start of treatment, followed by visits every 12 weeks until disease progression. | Randomized participants with data available at the specified time points. Number analyzed refers to the number of participants with an evaluable value at the specified time point. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, every 2 cycles after randomization during 18 months, then every 3 cycles up to end of treatment (EOT); EOT; and every 8 or 12 weeks post-treatment until progression, assessed up to approximately 29 months. Cycle=28 days |
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| Post-Hoc | All Collected Deaths | On-treatment deaths were collected from start of treatment to 30 days after last dose of treatment or one day before first administration of crossover treatment (for crossover participants), whichever came first. Crossover on-treatment deaths were collected from start of crossover treatment up to 30 days after last dose of crossover treatment. Post-treatment survival follow-up deaths were collected from day 31 after last dose of study treatment to end of study or one day before first administration of crossover treatment Crossover post-treatment survival follow-up deaths were collected from day 31 after last dose of crossover treatment to end of study | FAS including all randomized participants | Posted | Number | Participants | On-treatment: Up to 90 months. Crossover on-treatment: Up to approximately 33 months after crossing-over. Post-treatment survival follow-up: Up to 90 months. Crossover post-treatment survival follow-up: Up to approximately 33 months after crossing-over |
|
On-treatment: from 1st dose to 30 days post-treatment or start of crossover treatment, up to 90 months Crossover on-treatment: from 1st dose of crossover treatment to 30 days post-crossover treatment, up to approximately 33 months. Post-treatment survival follow-up: from day 31 post-treatment to end of study or start of crossover treatment, up to 90 months. Crossover post-treatment survival follow-up period from day 31 post-crossover treatment to end of study, up to approximately 33 months.
Safety analyses were performed in the safety set, including all participants who received at least one dose of study treatment. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ribociclib + NSAI/Tamoxifen + Goserelin (On-treatment) | AEs collected during on-treatment period (up to 30 days post-treatment) | 5 | 335 | 81 | 335 | 326 | 335 |
| EG001 | Placebo + NSAI/Tamoxifen+ Goserelin (On-treatment) | AEs collected during on-treatment period (up to 30 days post-treatment or start of crossover treatment) | 6 | 337 | 49 | 337 | 312 | 337 |
| EG002 | Placebo Crossover to Ribociclib (On-Treatment) | AEs collected during crossover on-treatment period with ribociclib for participants randomized to placebo arm who crossed-over to ribociclib (up to 30 days post- crossover treatment) | 0 | 17 | 1 | 17 | 14 | 17 |
| EG003 | Ribociclib + NSAI/Tamoxifen + Goserelin (Post-treatment Survival Follow-up) | Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment to end of study). No AEs were collected during this period | 168 | 251 | 0 | 0 | 0 | 0 |
| EG004 | Placebo + NSAI/Tamoxifen+ Goserelin (Post-treatment Survival Follow-up) | Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment to end of study or start of crossover treatment). No AEs were collected during this period | 202 | 293 | 0 | 0 | 0 | 0 |
| EG005 | Placebo Crossover to Ribociclib (Post-treatment Survival Follow-up) | Deaths collected in the crossover post- treatment survival follow-up period (starting from day 31 post-crossover treatment to end of study). No AEs were collected during this period | 1 | 17 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hepatic haemorrhage | Hepatobiliary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| SARS-CoV-2 antibody test positive | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Benign soft tissue neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| HER2 positive breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| Intracranial tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Superior sagittal sinus thrombosis | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Obsessive-compulsive disorder | Psychiatric disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Paranasal sinus inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Aortic thrombosis | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Gingival swelling | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Mucosal haemorrhage | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hepatic pain | Hepatobiliary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Contrast media reaction | Immune system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Post procedural erythema | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| SARS-CoV-2 test negative | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure Office | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 9, 2023 | Feb 13, 2024 | SAP_003.pdf |
| ID | Term |
|---|---|
| C000589651 | ribociclib |
| D013629 | Tamoxifen |
| D000077289 | Letrozole |
| D000077384 | Anastrozole |
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided
| Study terminated as per protocol |
|
| Progressive disease |
|
| Physician Decision |
|
| Male |
|
| Asian |
|
| Black |
|
| Native American |
|
| Other |
|
| Unknown |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
Placebo daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days).
|
|
|
|
|
|
|
| Placebo + NSAI/Tamoxifen+ Goserelin |
Placebo daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days). |
|
|
Placebo daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days). |
|
|
Placebo daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days).
|
|
|
|