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To compare the combination of Ribociclib plus goserelin acetate with hormonal therapy versus combination chemotherapy in premenopausal or perimenopausal patients with advanced or metastatic breast cancer
Patients were randomly assigned to one of the below treatment arms in 1:1 ratio:
The study consisted of a 28-day Screening phase, treatment phase (including end of treatment (EOT) visit and safety follow-up), and survival follow-up. Patients received study treatment until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason.
Patients were followed for survival regardless of treatment discontinuation for any reason (except if consent was withdrawn, patient was lost to follow-up, or until death) and regardless of achieving the primary endpoint, until death, withdrawal of consent, or loss to follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ribociclib 600 mg | Experimental | Combination of non-steroidal aromatase inhibitor: NSAI (letrozole or anastrozole) + goserelin + ribociclib.
|
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | 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). | Up to approximately 34 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Treatment Failure | Time to treatment failure was defined as the time from the date of randomization/start of treatment to the earliest of date of progression, date of death due to any cause, change to other anti-cancer therapy, or date of discontinuation due to reasons other than 'Protocol violation' or 'Administrative problems'. Patients who did not achieve a confirmed PR or CR were censored at: the maximum follow-up time (i.e., LPLV - first patient first visit [FPFV] used for the analysis) for patients who had a PFS event (i.e., either progressed or died due to any cause); the last adequate tumor assessment date for all other patients. |
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INCLUSION CRITERIA
Patient was an adult female ≥ 18 years old and < 60 years old at the time of informed consent.
Patient had a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory. ER should have been more than 10% ER positive or Allred ≥5 by local laboratory testing.
Patient had HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1 + or 2 + If IHC is 2 +, a negative in situ hybridization (FISH, CISH, or SISH) test was required by local laboratory testing and based on the most recently analyzed tissue sample.
Women with inoperable locally advanced or metastatic breast cancer not amenable to curative therapy. Patients had to fulfill at least one of the following criteria to be considered that combination chemotherapy was needed according to PI's judgment. However, for patients who were eligible under inoperable locally advanced breast cancer or criteria 4c, the recruitment was stopped to enrich patient population with visceral metastases.
Patient was premenopausal or perimenopausal at the time of study entry.
Premenopausal status was defined as either:
Perimenopausal status was defined as neither premenopausal nor postmenopausal.
Patients had received neither prior hormonal therapy nor chemotherapy for advanced breast cancer, except LHRH agonist. Patients who received ≤ 14 days of tamoxifen or a NSAI (letrozole or anastrozole) with or without LHRH agonist for advanced breast cancer prior to randomization were eligible. Patient had measurable disease.
EXCLUSION CRITERIA;
Patient received prior systemic anti-cancer therapy (including hormonal therapy and chemotherapy, or any CDK4/6 inhibitor for advanced breast cancer).
Patient had received extended-field radiotherapy ≤ 2 weeks prior to randomization or limited field radiotherapy ≤ 2 weeks prior to randomization, and had not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion). Patient from whom ≥ 25% of the bone marrow had been previously irradiated were also excluded.
Patient had a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated, basal or squamous cell skin carcinoma or curatively resected cervical cancer in situ.
Patients who had lung metastases with oxygen demand in resting status.
Patients who had liver metastases with bilirubin > 1.5 ULN.
Patients with CNS involvement unless they met ALL of the following criteria:
Patient was an adult female ≥ 18 years old and < 60 years old at the time of informed consent.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Cairo | 11566 | Egypt | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38771995 | Derived | Lu YS, Mahidin EIBM, Azim H, Eralp Y, Yap YS, Im SA, Rihani J, Gokmen E, El Bastawisy A, Karadurmus N, Lim YN, Lim CS, Duc LT, Chung WP, Babu KG, Penkov K, Bowles J, Alfaro TD, Wu J, Gao M, Slimane K, El Saghir NS. Final Results of RIGHT Choice: Ribociclib Plus Endocrine Therapy Versus Combination Chemotherapy in Premenopausal Women With Clinically Aggressive Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer. J Clin Oncol. 2024 Aug 10;42(23):2812-2821. doi: 10.1200/JCO.24.00144. Epub 2024 May 21. |
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novctrd.com | View source |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Ribociclib 600 mg | Combination of non-steroidal aromatase inhibitor: NSAI (letrozole or anastrozole) + goserelin + ribociclib.
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Mar 4, 2021 | May 9, 2024 |
This was a randomized, phase II, open label, multi-center trial comparing the combination of NSAI (letrozole or anastrozole) + goserelin + ribociclib versus combination chemotherapy (either of docetaxel/capecitabine or paclitaxel/gemcitabine or capecitabine/vinorelbine). Premenopausal or perimenopausal women with HR+, HER2- negative, advanced breast cancer with ECOG performance status of 0 to 2 and having symptomatic visceral metastases, or rapid progression of disease or impending visceral compromise, or markedly symptomatic non visceral disease were considered for this study.
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|
|
| 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) |
|
|
| Ribociclib | Drug | Dose: 600 mg (200 mg * 3) Days 1 to 21 of each 28 day cycle Tablets for oral use |
|
|
| 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. |
|
|
| Goserelin | Drug | Dose: 3.6 mg Day 1 of each 28 day cycle (regardless of ribociclib treatment cycle) with an administration window of + 3 days. Subcutaneous implant |
|
|
| Up to approximately 34 months |
| 3-month Treatment Failure Rate | Treatment failure rate was defined as the percentage of patients who discontinued the study treatment due to progressive disease, death due to any cause, change to other anti-cancer therapy, or discontinuation due to reasons other than protocol violation or administrative problems. | Up to approximately 3 months |
| Overall Response Rate (ORR) | Overall response rate (ORR) was defined as the percentage of patients with a best overall response (BOR) of complete response (CR) or partial response (PR, response without image confirmation), as per local review and according to RECIST 1.1. | Up to approximately 34 months |
| Clinical Benefit Rate | Clinical benefit rate was defined as the percentage of patients with a BOR of CR, PR, or stable disease (SD, response without image confirmation) lasting 24 weeks or longer, as defined by RECIST 1.1. | Up to approximately 34 months |
| Time to Response | Time to response was defined as the time from the date of randomization to the first documented response of either CR or PR, which must be subsequently confirmed, as defined by RECIST 1.1. Patients who did not achieve a confirmed PR or CR were censored at: the maximum follow-up time (i.e., LPLV - FPFV used for the analysis) for patients who had a PFS event (i.e., either progressed or died due to any cause); the last adequate tumor assessment date for all other patients. | Up to approximately 34 months |
| Overall Survival (OS) | Overall survival was defined as the time from the date of randomization to the date of death due to any cause. If a patient was not known to have died at the time of LPLV, then OS was censored at the last contact date. | Up to approximately 46 months |
| Change From Baseline in the Global Health Status/Quality of Life (QOL) Scale Score by Using the Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire | FACT-B is a self-reported instrument that measures multidimensional quality of life (QOL) in patients with breast cancer. The FACT-B consists of 37 questions that address physical, social, emotional, and functional well-being, with specific questions relevant to women with breast cancer. Each item has a score range of 0 (Not at all) to 4 (Very much), with a total score ranging from 0-148. The higher the score, the better the QOL reported by the participant. A positive change from baseline indicates improvement in QoL. | Up to approximately 46 months |
| Number of Patients With Adverse Events, Categorized by Severity | Adverse events were assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 or higher. If CTCAE grading did not exist for an adverse event, the severity of mild, moderate, severe, and life-threatening, corresponding to Grades 1 - 4, were used. A patient with multiple severity grades for an AE was only counted under the maximum grade. Data for Grades 3 and 4 are reported. | Up to approximately 46 months |
| Number of Patients With Laboratory Abnormalities | Grading of laboratory values was assigned programmatically as per NCI Common Terminology Criteria for Adverse Events (CTCAE) version available at the time of analysis. The calculation of CTCAE grades was based on the observed laboratory values only, clinical assessments were not be taken into account. CTCAE Grade 0 was assigned for all non-missing values not graded as 1 or higher. Grade 5 was not used. For laboratory tests where grades were not defined by CTCAE available at the time of analysis, results were categorized as low/normal/high based on laboratory normal ranges. | Up to approximately 46 months |
| Post-Hoc: All Collected Deaths | On-treatment deaths due to any cause were collected from first dose of study medication to 30 days after the last dose of study treatment. Post-treatment survival follow-up deaths were collected from day 31 after last dose of study medication to end of study. | On-treatment deaths: Up to approximately 46 months. Post-treatment survival follow-up deaths: Up to approximately 2 additional months. |
| Cairo |
| 12655 |
| Egypt |
| Novartis Investigative Site | Cairo | 3247511 | Egypt |
| Novartis Investigative Site | Giza | 11451 | Egypt |
| Novartis Investigative Site | Bangalore | Karnataka | 560 095 | India |
| Novartis Investigative Site | Pune | Maharashtra | 411004 | India |
| Novartis Investigative Site | Hyderabad | Telangana | 500082 | India |
| Novartis Investigative Site | Kolkata | West Bengal | 700099 | India |
| Novartis Investigative Site | Mumbai | 400 012 | India |
| Novartis Investigative Site | New Delhi | 110029 | India |
| Novartis Investigative Site | Amman | 11941 | Jordan |
| Novartis Investigative Site | Beirut | 1107 2020 | Lebanon |
| Novartis Investigative Site | Saida | 652 | Lebanon |
| Novartis Investigative Site | Tripoli | 1434 | Lebanon |
| Novartis Investigative Site | Johor Bahru | Johor | 81100 | Malaysia |
| Novartis Investigative Site | Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
| Novartis Investigative Site | Kota Kinabalu | Sabah | 88586 | Malaysia |
| Novartis Investigative Site | Kuching | Sarawak | 93586 | Malaysia |
| Novartis Investigative Site | Pulau Pinang | 10990 | Malaysia |
| Novartis Investigative Site | Moscow | 111123 | Russia |
| Novartis Investigative Site | Moscow | 115478 | Russia |
| Novartis Investigative Site | Pushkin Saint Petersburg | 196603 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197758 | Russia |
| Novartis Investigative Site | Riyadh | 11211 | Saudi Arabia |
| Novartis Investigative Site | Singapore | 168583 | Singapore |
| Novartis Investigative Site | Singapore | 188770 | Singapore |
| Novartis Investigative Site | Singapore | 258499 | Singapore |
| Novartis Investigative Site | Durban | KwaZulu-Natal | 4091 | South Africa |
| Novartis Investigative Site | Pretoria | 0002 | South Africa |
| Novartis Investigative Site | Pretoria | 0081 | South Africa |
| Novartis Investigative Site | Kaohsiung City | 83301 | Taiwan |
| Novartis Investigative Site | Taichung | 40447 | Taiwan |
| Novartis Investigative Site | Tainan | 70403 | Taiwan |
| Novartis Investigative Site | Taipei | 10002 | Taiwan |
| Novartis Investigative Site | Taipei | 10449 | Taiwan |
| Novartis Investigative Site | Taipei | 11217 | Taiwan |
| Novartis Investigative Site | Taipei | 114 | Taiwan |
| Novartis Investigative Site | Taoyuan | 33305 | Taiwan |
| Novartis Investigative Site | Songkhla | Hat Yai | 90110 | Thailand |
| Novartis Investigative Site | Bangkok | 10310 | Thailand |
| Novartis Investigative Site | Bangkok | 10400 | Thailand |
| Novartis Investigative Site | Chiang Mai | 50200 | Thailand |
| Novartis Investigative Site | Cankaya Ankara | Turkey | 06560 | Turkey (Türkiye) |
| Novartis Investigative Site | Kecioren Ankara | Turkey | 06010 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | 06520 | Turkey (Türkiye) |
| Novartis Investigative Site | Antalya | 07059 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | 34381 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | 35040 | Turkey (Türkiye) |
| Novartis Investigative Site | Malatya | 44280 | Turkey (Türkiye) |
| Novartis Investigative Site | Hanoi | 100000 | Vietnam |
| FG001 | Combination Chemotherapy | 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. |
| Treated |
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| Not Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The full analysis set comprised all patients to whom study treatment was assigned by randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ribociclib 600 mg | Combination of non-steroidal aromatase inhibitor: NSAI (letrozole or anastrozole) + goserelin + ribociclib.
|
| BG001 | Combination Chemotherapy | 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. |
| 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/Gender, Customized | Number | participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Height | Data are reported for participants in the full analysis set who had available data. | Mean | Standard Deviation | cm |
|
| 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 | 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). | The full analysis set comprised all patients to whom study treatment was assigned by randomization. | Posted | Median | 95% Confidence Interval | months | Up to approximately 34 months |
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| Secondary | Time to Treatment Failure | Time to treatment failure was defined as the time from the date of randomization/start of treatment to the earliest of date of progression, date of death due to any cause, change to other anti-cancer therapy, or date of discontinuation due to reasons other than 'Protocol violation' or 'Administrative problems'. Patients who did not achieve a confirmed PR or CR were censored at: the maximum follow-up time (i.e., LPLV - first patient first visit [FPFV] used for the analysis) for patients who had a PFS event (i.e., either progressed or died due to any cause); the last adequate tumor assessment date for all other patients. | The full analysis set comprised all patients to whom study treatment was assigned by randomization. | Posted | Median | 95% Confidence Interval | months | Up to approximately 34 months |
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| Secondary | 3-month Treatment Failure Rate | Treatment failure rate was defined as the percentage of patients who discontinued the study treatment due to progressive disease, death due to any cause, change to other anti-cancer therapy, or discontinuation due to reasons other than protocol violation or administrative problems. | The full analysis set comprised all patients to whom study treatment was assigned by randomization. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 3 months |
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| Secondary | Overall Response Rate (ORR) | Overall response rate (ORR) was defined as the percentage of patients with a best overall response (BOR) of complete response (CR) or partial response (PR, response without image confirmation), as per local review and according to RECIST 1.1. | The full analysis set comprised all patients to whom study treatment was assigned by randomization. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 34 months |
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| Secondary | Clinical Benefit Rate | Clinical benefit rate was defined as the percentage of patients with a BOR of CR, PR, or stable disease (SD, response without image confirmation) lasting 24 weeks or longer, as defined by RECIST 1.1. | The full analysis set comprised all patients to whom study treatment was assigned by randomization. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 34 months |
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| Secondary | Time to Response | Time to response was defined as the time from the date of randomization to the first documented response of either CR or PR, which must be subsequently confirmed, as defined by RECIST 1.1. Patients who did not achieve a confirmed PR or CR were censored at: the maximum follow-up time (i.e., LPLV - FPFV used for the analysis) for patients who had a PFS event (i.e., either progressed or died due to any cause); the last adequate tumor assessment date for all other patients. | The full analysis set comprised all patients to whom study treatment was assigned by randomization. | Posted | Median | 95% Confidence Interval | months | Up to approximately 34 months |
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| Secondary | Overall Survival (OS) | Overall survival was defined as the time from the date of randomization to the date of death due to any cause. If a patient was not known to have died at the time of LPLV, then OS was censored at the last contact date. | The full analysis set comprised all patients to whom study treatment was assigned by randomization. | Posted | Median | 95% Confidence Interval | months | Up to approximately 46 months |
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| Secondary | Change From Baseline in the Global Health Status/Quality of Life (QOL) Scale Score by Using the Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire | FACT-B is a self-reported instrument that measures multidimensional quality of life (QOL) in patients with breast cancer. The FACT-B consists of 37 questions that address physical, social, emotional, and functional well-being, with specific questions relevant to women with breast cancer. Each item has a score range of 0 (Not at all) to 4 (Very much), with a total score ranging from 0-148. The higher the score, the better the QOL reported by the participant. A positive change from baseline indicates improvement in QoL. | The full analysis set comprised all patients to whom study treatment was assigned by randomization. Results are reported for participants with data available at the specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Up to approximately 46 months |
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| Secondary | Number of Patients With Adverse Events, Categorized by Severity | Adverse events were assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 or higher. If CTCAE grading did not exist for an adverse event, the severity of mild, moderate, severe, and life-threatening, corresponding to Grades 1 - 4, were used. A patient with multiple severity grades for an AE was only counted under the maximum grade. Data for Grades 3 and 4 are reported. | The safety set included all patients who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to approximately 46 months |
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| Secondary | Number of Patients With Laboratory Abnormalities | Grading of laboratory values was assigned programmatically as per NCI Common Terminology Criteria for Adverse Events (CTCAE) version available at the time of analysis. The calculation of CTCAE grades was based on the observed laboratory values only, clinical assessments were not be taken into account. CTCAE Grade 0 was assigned for all non-missing values not graded as 1 or higher. Grade 5 was not used. For laboratory tests where grades were not defined by CTCAE available at the time of analysis, results were categorized as low/normal/high based on laboratory normal ranges. | The safety set included all patients who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to approximately 46 months |
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| Secondary | Post-Hoc: All Collected Deaths | On-treatment deaths due to any cause were collected from first dose of study medication to 30 days after the last dose of study treatment. Post-treatment survival follow-up deaths were collected from day 31 after last dose of study medication to end of study. | All participants to whom study treatment was assigned. | Posted | Count of Participants | Participants | On-treatment deaths: Up to approximately 46 months. Post-treatment survival follow-up deaths: Up to approximately 2 additional months. |
|
From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were 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 600 mg (On-treatment) | AEs during the on-treatment period (up to 30 days post-treatment) | 5 | 112 | 17 | 112 | 112 | 112 |
| EG001 | Combination Chemotherapy (On-treatment) | AEs during the on-treatment period (up to 30 days post-treatment) | 0 | 100 | 16 | 100 | 100 | 100 |
| EG002 | Ribociclib 600 mg (Post-treatment Survival Follow-up) | Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period. | 29 | 107 | 0 | 0 | 0 | 0 |
| EG003 | Combination Chemotherapy (Post-treatment Survival Follow-up) | Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period. | 29 | 92 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Catheter site cellulitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumothorax traumatic | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Electrocardiogram T wave inversion | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Lymphangiosis carcinomatosa | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Menopause | Social circumstances | MedDRA (25.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.0) | 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 the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 23, 2022 | May 9, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D000069287 | Capecitabine |
| D000077235 | Vinorelbine |
| D017239 | Paclitaxel |
| D000093542 | Gemcitabine |
| C000589651 | ribociclib |
| D000077289 | Letrozole |
| D000077384 | Anastrozole |
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| 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
|
|
| White |
|
|
| Black or African American |
|
|
|
| Not Reported |
|
|
| Hispanic or Latino |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|
| Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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|
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. |
|
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|
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|
| Units | Counts |
|---|---|
| Participants |
|
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