Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003757-28 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This was a three-arm, randomized, open label, multi-center phase II study investigating the combination of everolimus (10mg daily) with exemestane (25mg daily) versus everolimus (10mg daily) versus capecitabine (1250mg/m2 twice daily for 14 days, 3-week cycle) in patients with estrogen-receptor positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole.
The reference therapy (control arm) used in the course of this trial was the combination arm of everolimus plus exemestane. The investigational therapies in the context of this study were everolimus monotherapy and capecitabine monotherapy. All treatments were taken orally until disease progression, intolerable toxicity or withdrawal of patient's informed consent. Patients were randomly assigned with equal allocation to one of the treatment arms:
Treatment assignment was stratified by the presence of visceral disease (yes vs. no). Visceral refered to lung, liver, heart, ovary, spleen, kidney, adrenal gland, malignant pleural or pericardial effusion or malignant ascites.
Randomization and Treatment Phase:
At Visit 3 all eligible patients were randomized in 1:1:1 ratio to receive everolimus (10mg daily oral tablets) in combination with exemestane (25 mg daily oral tablets), everolimus (10mg daily oral tablets) or capecitabine monotherapy (1250mg/m2 twice daily orally for two weeks followed by a one week rest period in 3-weeks cycles). Assignment was stratified by the presence of visceral disease (yes vs. no). Visceral refered to lung, liver, heart, ovary, spleen, kidney, adrenal gland, malignant pleural or pericardial effusion or malignant ascites. After randomization, study treatment started and continued until progression, intolerable toxicity or consent withdrawal. Further treatment after progression and study treatment discontinuation was at the investigator's discretion. Dose adjustment (reduction, interruption) according to safety findings was allowed. Regular safety and efficacy reviews by Data Monitoring Committee (DMC) were performed. Tumor assessments were performed every 6 weeks until disease progression. Additional evaluation were performed to confirm response at 4 weeks after it was first observed. After at least 150 PFS events had been documented per RECIST 1.1 by local assessment in each of the two following groups: (i) everolimus + exemestane arm plus everolimus monotherapy arm, and (ii) everolimus + exemestane arm plus capecitabine monotherapy arm, the frequency of tumor assessments was changed to every 12 weeks or as clinically indicated.
Follow-up phase:
Patients were followed for safety for 30 days after study treatment discontinuation. If a patient did not discontinue study treatment due to disease progression, lost to follow-up or consent withdrawal, then tumor assessments continued to be performed every 6 weeks until disease progression, death, lost to follow-up or investigator decision in patient best interest.
Survival Data Collection:
All patients were followed for survival status at least every 3 months regardless of treatment discontinuation reason and up to two years after randomization of last patient. Survival information could be obtained via phone and information were documented in the source documents and eCRF. Additional survival follow-up might be performed more frequently if a survival update was required for reporting the results or to meet safety or regulatory needs.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capecitabine 1250 mg/m2 | Experimental | Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm). |
|
| Everolimus 10 mg | Experimental | Everolimus (10 mg daily) (investigational arm). |
|
| Everolimus 10 mg + Exemestane 25 mg | Active Comparator | Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | Capecitabine, tablets for oral use, 1250 mg/m² twice daily for 2 weeks followed by one week rest (3-week-cycle) (locally supplied) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) - Everolimus Plus Exemestane Versus Everolimus Alone | Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. PFS was compared between the everolimus + exemestane combination therapy with the everolimus monotherapy. | Date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to 39 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) - Everolimus Plus Exemestane Versus Capecitabine Alone | Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. PFS was compared between the everolimus + exemestane combination therapy with the everolimus monotherapy. |
Not provided
Key Inclusion Criteria:
- Women with locally advanced, recurrent, or metastatic breast cancer along with confirmation of estrogen-receptor positive (ER+). Measurable disease defined as at least one lesion ≥ 10 mm by CT or MRI that can be accurately measured in at least one dimension (CT scan slice thickness ≤ 5 mm) OR • Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as defined above.
Key Exclusion Criteria:
- Patients who received more than one chemotherapy line. Patients with only non-measurable lesions other than lytic or mixed (lytic and blastic) bone metastasis.Previous treatment with exemestane, mTOR inhibitors, PI3K inhibitors or AKT inhibitors.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at Los Angeles Mattel Children's Hospital | Los Angeles | California | 90095 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29862411 | Derived | Jerusalem G, de Boer RH, Hurvitz S, Yardley DA, Kovalenko E, Ejlertsen B, Blau S, Ozguroglu M, Landherr L, Ewertz M, Taran T, Fan J, Noel-Baron F, Louveau AL, Burris H. Everolimus Plus Exemestane vs Everolimus or Capecitabine Monotherapy for Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer: The BOLERO-6 Randomized Clinical Trial. JAMA Oncol. 2018 Oct 1;4(10):1367-1374. doi: 10.1001/jamaoncol.2018.2262. |
Not provided
Not provided
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
Not provided
Not provided
Not provided
A total of 300 subjects were planned and total of 309 subjects were randomized to everolimus plus exemestane (control arm) (N = 104), everolimus alone (N = 103), or capecitabine (N = 102).
This study was conducted at 84 centers in 18 countries worldwide: Belgium (1), Denmark (6), Hungary (3), Ireland (3), Spain (4), Sweden (6), United Kingdom (3), United States (19), Argentina (6), Brazil (5), Peru (4), India (4), Lebanon (5), Malaysia (2), Russia (3), Thailand (3), Turkey (3) Australia (4)
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Everolimus 10 mg + Exemestane 25 mg | Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm). |
| FG001 | Everolimus 10 mg | Everolimus (10 mg daily) (investigational arm). |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Treatment Phase |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 27, 2017 | Apr 29, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Exemestane | Drug | Exemestane, tablets for oral use, 25 mg per day in (locally supplied) |
|
|
| Everolimus | Drug | Everolimus, 5 mg tablets for oral use, 10 mg (2 x 5 mg) per day (centrally supplied) |
|
|
| Date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to 39 months |
| Overall Survival (OS) | Overall Survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last known date patient alive. | Every 3 months following end of treatment visit, assessed for approximately 54 months |
| Overall Response Rate (ORR) | Overall Response Rate (ORR) as the proportion of patients whose best overall response is either complete response (CR) or partial response (PR) according to RECIST 1.1 This was assessed in the full patient population. Complete response is achieved when all lesions evaluated at baseline are absent at subsequent visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Only descriptive statistics. | From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 43 months |
| Clinical Benefit Rate (CBR) | Clinical Benefit Rate (CBR) is defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) or Non-CR/non-PD lasting more than 24 weeks based on local investigator's assessment according to RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR, Stable disease (SD), neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; CBR = CR+PR+SD. Only descriptive statistics. | From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 43 months |
| Time to Eastern Cooperative Oncology Group (ECOG) Performance Deterioration | The Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale used to assess physical health of subjects,ranging from 0 (most active) to 5 (least active). Definitive deterioration is defined as no improvement in the ECOG status following observation of the deterioration. | Baseline, every 6 weeks up to about 43 months |
| Time to 10% Definitive Deterioration in the Global Health Status / Quality of Life | The global health status/QoL scale score of the QLQ-C30 is identified as the primary PRO variable of interest. Physical Functioning (PF), Emotional Functioning (EF) and Social Functioning (SF) scale scores of the QLQ-C30. The time to definitive 10% deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen. Definitive 10% (5-point) deterioration is defined as a decrease in score by at least 10% (5-points) compared to baseline, with no later increase above this threshold observed during the course of the study. | Baseline, every 6 weeks up to about 43 months |
| Mean Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Between Week 3 and 12 | TSQM was used to measure the Patients' self-reported satisfaction or dissatisfaction with the study treatment. The differences in mean scale scores between weeks 3 and 12 comparing treatment satisfaction in the different treatment arms: everolimus + exemestane combination therapy versus everolimus monotherapy, and everolimus + exemestane combination therapy versus capecitabine monotherapy. The TSQM version 1.4 domain scores range from 0 to 100 with higher scores representing a higher satisfaction on that domain. | Week 3, Week 12 |
| Sharp Memorial Hospital SharpClinicalOncologyResearch |
| San Diego |
| California |
| 92123 |
| United States |
| Florida Cancer Specialists Dept of Oncology (2) | Fort Myers | Florida | 33901 | United States |
| Florida Cancer Specialists FL Cancer Specialists | Fort Myers | Florida | 33901 | United States |
| Lahey Clinic Dept of Lahey Clinic (2) | Burlington | Massachusetts | 01805 | United States |
| New England Hematology/ Oncology Associates, P.C. SC | Newton | Massachusetts | 02462 | United States |
| Glacier View Research Institute - Cancer SC | Kalispell | Montana | 59901 | United States |
| Trinitas Comprehensive Cancer Center SC | Elizabeth | New Jersey | 07207 | United States |
| Hackensack University Medical Center Dept of Oncology | Hackensack | New Jersey | 07601 | United States |
| Rutgers-New Jersey Medical School SC | Newark | New Jersey | 07101 | United States |
| Oncology Hematology Care Inc Oncology Hematology Care 2 | Cincinnati | Ohio | 45242 | United States |
| Oklahoma Cancer Specialists and Research Institute Oklahoma Cancer Specialists | Tulsa | Oklahoma | 74136 | United States |
| Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology | Chattanooga | Tennessee | 37404 | United States |
| The Jones Clinic SC | Germantown | Tennessee | 38138 | United States |
| University of Tennessee SC | Knoxville | Tennessee | 27920-6969 | United States |
| Sarah Cannon Research Institute SC (2) | Nashville | Tennessee | 37203 | United States |
| The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD | Fort Worth | Texas | 76104 | United States |
| University of Virginia Health Systems SC-4 | Charlottesville | Virginia | 22908-0334 | United States |
| Northwest Medical Specialties Dept of Onc | Tacoma | Washington | 98405 | United States |
| Novartis Investigative Site | CABA | Buenos Aires | C1025ABI | Argentina |
| Novartis Investigative Site | Posadas | Misiones Province | Argentina |
| Novartis Investigative Site | Rosario | Santa Fe Province | S2000KZE | Argentina |
| Novartis Investigative Site | Rio Negro | Viedma | 8500 | Argentina |
| Novartis Investigative Site | Córdoba | X5016KEH | Argentina |
| Novartis Investigative Site | Randwick | New South Wales | 2031 | Australia |
| Novartis Investigative Site | Wahroonga | New South Wales | 2076 | Australia |
| Novartis Investigative Site | Malvern | Victoria | 3144 | Australia |
| Novartis Investigative Site | Parkville | Victoria | 3050 | Australia |
| Novartis Investigative Site | Liège | 4000 | Belgium |
| Novartis Investigative Site | Salvador | Estado de Bahia | 41253-190 | Brazil |
| Novartis Investigative Site | Natal | Rio Grande do Norte | 59075 740 | Brazil |
| Novartis Investigative Site | Passo Fundo | Rio Grande do Sul | 99010-260 | Brazil |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 01317-002 | Brazil |
| Novartis Investigative Site | Aarhus | 8000 C | Denmark |
| Novartis Investigative Site | Copenhagen | DK-2100 | Denmark |
| Novartis Investigative Site | Næstved | DK-4700 | Denmark |
| Novartis Investigative Site | Odense C | DK 5000 | Denmark |
| Novartis Investigative Site | Roskilde | 4000 | Denmark |
| Novartis Investigative Site | Vejle | 7100 | Denmark |
| Novartis Investigative Site | Budapest | HUN | 1145 | Hungary |
| Novartis Investigative Site | Debrecen | 4032 | Hungary |
| Novartis Investigative Site | Tatabánya | 2800 | Hungary |
| Novartis Investigative Site | Hyderabad | Andhra Pradesh | 500 034 | India |
| Novartis Investigative Site | Pune | Maharashtra | 411013 | India |
| Novartis Investigative Site | Kolkata | West Bengal | 700 053 | India |
| Novartis Investigative Site | Mumbai | 400 012 | India |
| Novartis Investigative Site | Limerick | Co Limerick | Ireland |
| Novartis Investigative Site | Dublin | D04 T6F | Ireland |
| Novartis Investigative Site | Galway | Ireland |
| Novartis Investigative Site | Beirut | 1107 2020 | Lebanon |
| Novartis Investigative Site | Beirut | Lebanon |
| Novartis Investigative Site | El Achrafiyé | 166830 | Lebanon |
| Novartis Investigative Site | Hazmiyeh | 470 | Lebanon |
| Novartis Investigative Site | Saida | 652 | Lebanon |
| Novartis Investigative Site | Kota Kinabalu | Sabah | 88586 | Malaysia |
| Novartis Investigative Site | Kuala Lumpur | 59100 | Malaysia |
| Novartis Investigative Site | Jesus Maria | Lima region | 11 | Peru |
| Novartis Investigative Site | San Borja | Lima region | 41 | Peru |
| Novartis Investigative Site | Surquillo | Lima region | 34 | Peru |
| Novartis Investigative Site | Arequipa | Peru |
| Novartis Investigative Site | Arkhangelsk | 163045 | Russia |
| Novartis Investigative Site | Moscow | 115478 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197758 | Russia |
| Novartis Investigative Site | Seville | Andalusia | 41013 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Madrid | 28033 | Spain |
| Novartis Investigative Site | Madrid | 28040 | Spain |
| Novartis Investigative Site | Eskilstuna | SE-631 88 | Sweden |
| Novartis Investigative Site | Jönköping | 551 85 | Sweden |
| Novartis Investigative Site | Stockholm | SE-171 76 | Sweden |
| Novartis Investigative Site | Uppsala | SE-751 85 | Sweden |
| Novartis Investigative Site | Vaxjo | SE-351 85 | Sweden |
| Novartis Investigative Site | Västerås | 721 89 | Sweden |
| Novartis Investigative Site | Lopburi | Changwat Lop Buri | 15000 | Thailand |
| Novartis Investigative Site | Songkhla | Hat Yai | 90110 | Thailand |
| Novartis Investigative Site | Muang | 40002 | Thailand |
| Novartis Investigative Site | Adana | 01330 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | 34303 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | 35340 | Turkey (Türkiye) |
| Novartis Investigative Site | East Kilbride | G75 8RG | United Kingdom |
| Novartis Investigative Site | Middlesbrough | TS4 3BW | United Kingdom |
| Novartis Investigative Site | Nottingham | NG5 1PB | United Kingdom |
| FG002 | Capecitabine 1250 mg/m2 | Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm). |
|
| Safety Set | At least 1 dose of study treatment and a 1 post baseline safety assessment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Post-Treatment Efficacy Follow-Up Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Everolimus 10 mg + Exemestane 25 mg | Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm). |
| BG001 | Everolimus 10 mg | Everolimus (10 mg daily) (investigational arm). |
| BG002 | Capecitabine 1250 mg/m2 | Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm). |
| BG003 | 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| ECOG Performance Status | 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) - Everolimus Plus Exemestane Versus Everolimus Alone | Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. PFS was compared between the everolimus + exemestane combination therapy with the everolimus monotherapy. | Full Analysis Set (FAS), which consisted of all randomized patients, was considered. | Posted | Median | 90% Confidence Interval | Months | Date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to 39 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) - Everolimus Plus Exemestane Versus Capecitabine Alone | Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. PFS was compared between the everolimus + exemestane combination therapy with the everolimus monotherapy. | Full Analysis Set (FAS), which consisted of all randomized patients, was considered. | Posted | Median | 90% Confidence Interval | Months | Date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to 39 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall Survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last known date patient alive. | Full Analysis Set (FAS), which consisted of all randomized patients, was considered. | Posted | Median | 90% Confidence Interval | Months | Every 3 months following end of treatment visit, assessed for approximately 54 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | Overall Response Rate (ORR) as the proportion of patients whose best overall response is either complete response (CR) or partial response (PR) according to RECIST 1.1 This was assessed in the full patient population. Complete response is achieved when all lesions evaluated at baseline are absent at subsequent visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Only descriptive statistics. | Full Analysis Set (FAS), which consisted of all randomized patients, was considered. | Posted | Number | 90% Confidence Interval | Percentage of Participants | From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 43 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate (CBR) | Clinical Benefit Rate (CBR) is defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) or Non-CR/non-PD lasting more than 24 weeks based on local investigator's assessment according to RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR, Stable disease (SD), neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; CBR = CR+PR+SD. Only descriptive statistics. | Full Analysis Set (FAS), which consisted of all randomized patients, was considered. | Posted | Number | 90% Confidence Interval | Percentage of Participants | From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 43 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Eastern Cooperative Oncology Group (ECOG) Performance Deterioration | The Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale used to assess physical health of subjects,ranging from 0 (most active) to 5 (least active). Definitive deterioration is defined as no improvement in the ECOG status following observation of the deterioration. | Full Analysis Set (FAS), which consisted of all randomized patients, was considered. | Posted | Median | 90% Confidence Interval | Weeks | Baseline, every 6 weeks up to about 43 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to 10% Definitive Deterioration in the Global Health Status / Quality of Life | The global health status/QoL scale score of the QLQ-C30 is identified as the primary PRO variable of interest. Physical Functioning (PF), Emotional Functioning (EF) and Social Functioning (SF) scale scores of the QLQ-C30. The time to definitive 10% deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen. Definitive 10% (5-point) deterioration is defined as a decrease in score by at least 10% (5-points) compared to baseline, with no later increase above this threshold observed during the course of the study. | Full Analysis Set (FAS), which consisted of all randomized patients, was considered. | Posted | Median | 90% Confidence Interval | Weeks | Baseline, every 6 weeks up to about 43 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Between Week 3 and 12 | TSQM was used to measure the Patients' self-reported satisfaction or dissatisfaction with the study treatment. The differences in mean scale scores between weeks 3 and 12 comparing treatment satisfaction in the different treatment arms: everolimus + exemestane combination therapy versus everolimus monotherapy, and everolimus + exemestane combination therapy versus capecitabine monotherapy. The TSQM version 1.4 domain scores range from 0 to 100 with higher scores representing a higher satisfaction on that domain. | Full Analysis Set (FAS), which consisted of all randomized patients, was considered. Only participants who had both post-baseline assessments were included. | Posted | Mean | Standard Deviation | Unit on a scale | Week 3, Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | All Collected Deaths | On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Deaths post treatment survival follow up were collected after the on- treatment period, up to approximately 5 years. Patients who didn't die during the on-treatment period and had not stopped study participation at the time of data cut-off (end of study) were censored. | Clinical database population; all treated patients | Posted | Count of Participants | Participants | up to 224 weeks (on-treatment), up to approximately 5 years (study duration) |
|
Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks).
Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up.
Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
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 | Everolimus 10 mg + Exemestane 25 mg | Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm). | 9 | 104 | 37 | 104 | 103 | 104 |
| EG001 | Everolimus 10 mg | Everolimus (10 mg daily) (investigational arm). | 5 | 103 | 30 | 103 | 100 | 103 |
| EG002 | Capecitabine 1250 mg/m2 | Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm). | 2 | 102 | 30 | 102 | 99 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Drug intolerance | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Bacterial pyelonephritis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Infected cyst | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Ilium fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (21.0) | 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 (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 18, 2017 | Apr 29, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| C056516 | exemestane |
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| 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 |
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Withdrawal by Subject |
|
| Administrative Problems |
|
| New cancer therapy |
|
| Followup phase completed as per protocol |
|
| Male |
|
| Black |
|
| Asian |
|
| Native American |
|
| Other |
|
| Only Light Work |
|
| Only Self Care |
|
| Missing |
|
|
|
|
| Participants |
|
|
|
Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm).
|
|
| Capecitabine 1250 mg/m2 |
Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm). |
|
|
| Participants |
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|