Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001230-42 | EudraCT Number |
Not provided
Not provided
Not provided
Slow and low enrollment
Not provided
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Not provided
Not provided
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Not provided
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This trial is designed to enroll postmenopausal patients with locally advanced or metastatic, HER2- and HR+ breast cancer not amenable to curative treatment by surgery or radiotherapy, and whose disease has progressed on or after prior endocrine therapy.
Patients must undergo molecular pre-screening prior to entry.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fulvestrant + Dovitinib active | Experimental | Fulvestrant in combination with the study drug Dovitinib. |
|
| Fulvestrant + Dovitinib placebo | Placebo Comparator | Fulvestrant in combination with a placebo matching Dovitinib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dovitinib | Drug | Active Dovitinib (in tablet form) taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Based on Local Investigator Assessment | PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause and was assessed based on RECIST v1.1. Responses include: Complete Response: Disappearance of all non-nodal target lesions; Partial Response: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; Progressive Disease: At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline; Stable Disease: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline. | Every 8 weeks assessed up to 34 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR was defined as the percentage of patients with a best overall response of Complete Response (CR) or Partial Response (PR) as per RECIST v1.1. Responses include: Complete Response: Disappearance of all non-nodal target lesions; Partial Response: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; Progressive Disease: At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline; Stable Disease: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
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Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ironwood Cancer and Research Centers SC | Chandler | Arizona | 85224 | United States | ||
| Highlands Oncology Group Dept of Highlands Oncology Grp |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28183331 | Derived | Musolino A, Campone M, Neven P, Denduluri N, Barrios CH, Cortes J, Blackwell K, Soliman H, Kahan Z, Bonnefoi H, Squires M, Zhang Y, Deudon S, Shi MM, Andre F. Phase II, randomized, placebo-controlled study of dovitinib in combination with fulvestrant in postmenopausal patients with HR+, HER2- breast cancer that had progressed during or after prior endocrine therapy. Breast Cancer Res. 2017 Feb 10;19(1):18. doi: 10.1186/s13058-017-0807-8. |
Not provided
Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Fulvestrant + Dovitinib Active | Fulvestrant in combination with the study drug Dovitinib. |
| FG001 | Fulvestrant + Dovitinib Placebo | Fulvestrant in combination with a placebo matching Dovitinib. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Fulvestrant | Drug | Fulvestrant (in solution) injected intramuscularly at a dose of 500 mg once on Week 1 Day 1, Week 3 Day 1 and Week 5 Day 1 and subsequently once every 4 weeks on Day 1 of the week. |
|
| Dovitinib Placebo | Drug | Dovitinib Placebo (in tablet form) taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule |
|
| Every 8 weeks assessed up to 34 months |
| Duration of Response (DOR) | DOR was defined as time from the date of the first documented response (CR or PR) to the date of the first documented or death due to disease. If a patient does not have a progression event, DOR will be censored on the date of the last adequate tumor assessment. | From date of first documented efficacy response (CR or PR) to time of documented progression (PD) whichever comes first, assessed up to 24 months |
| Overall Survival (OS) Using Kaplan- Meier Method | OS was defined as the time from the date of randomization to the date of death from any cause. If a patient is not known to have died at the date of analysis cut-off, the OS will be censored at the last date of contact. | From date of randomization to date of death from any cause whichever comes first, assessed up to 34 months |
| Number of Participants With Adverse Events as a Measure of Safety | The type, frequency and severity of adverse events, laboratory values, and Electrocardiograms (ECGs) experienced by patients will be assessed according to Common Terminology Criteria for Adverse Events. The study enrollment was terminated early due to challenges in enrolling patients with FGF amplified status. See safety section for safety details. | Screening, Week 2, Week 4 and approximately every 4 weeks during treatment period (approximately 34 months) |
| Time to Worsening of ECOG Performance Status | Eastern Cooperative Oncology Group (ECOG) Performance Status (scales and criteria used by doctors and researchers to assess how a patient's disease is progressing and assess how the disease affects the daily living abilities of the patient.) | Screening, Every 4 weeks during treatment period, and every 8 weeks during follow-up (approximately 9-12 months) |
| Fayetteville |
| Arkansas |
| 72703 |
| United States |
| City of Hope National Medical Center COH 3 | Duarte | California | 91010-3000 | United States |
| University of California San Diego - Moores Cancer Center Moores UCSD Cancer Ctr. SC-1 | La Jolla | California | 92093-0658 | United States |
| Cedars Sinai Medical Center Samuel Oschin Cancer Center | Los Angeles | California | 90048 | United States |
| H. Lee Moffitt Cancer Center & Research Institute H. Lee Moffitt SC | Tampa | Florida | 33612 | United States |
| Oncology Specialists, SC Lutheran General Advanced Care | Park Ridge | Illinois | 60068-0736 | United States |
| Indiana University Health Goshen Center for Cancer SC | Goshen | Indiana | 46526 | United States |
| Nebraska Methodist Hospital Estabrook Cancer Center | Omaha | Nebraska | 68114 | United States |
| Saint Barnabas Medical Center CancerCenter of Saint Barnabas | Livingston | New Jersey | 07039 | United States |
| ProHealth Care | Lake Success | New York | 11042 | United States |
| New York Oncology Hematology, P.C. Dept. of New York Oncology. PC | Troy | New York | 12180 | United States |
| Duke University Medical Center Duke (SC) | Durham | North Carolina | 27710 | United States |
| Cancer Centers of the Carolinas Dept. of CC of the Carolinas | Greenville | South Carolina | 29605 | United States |
| Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2) | San Antonio | Texas | 78229 | United States |
| Virginia Cancer Specialists, PC Dept.ofFairfax SC | Fairfax | Virginia | 22031 | United States |
| Medical Oncology Associates, PS | Spokane | Washington | 99208 | United States |
| Wenatchee Valley Medical Center Wenatchee Valley | Wenatchee | Washington | 98801 | United States |
| Novartis Investigative Site | Buenos Aires | Buenos Aires | C1050AAK | Argentina |
| Novartis Investigative Site | Córdoba | Córdoba Province | X5006IKK | Argentina |
| Novartis Investigative Site | San Miguel de Tucumán | Tucumán Province | T4000IAK | Argentina |
| Novartis Investigative Site | Rio Negro | Viedma | 8500 | Argentina |
| Novartis Investigative Site | Salzburg | 5020 | Austria |
| Novartis Investigative Site | Vienna | 1090 | Austria |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Wilrijk | 2610 | Belgium |
| Novartis Investigative Site | Salvador | Estado de Bahia | 40170-110 | Brazil |
| Novartis Investigative Site | Londrina | Paraná | 86015-520 | Brazil |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Novartis Investigative Site | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 01317-002 | Brazil |
| Novartis Investigative Site | Besançon | 25030 | France |
| Novartis Investigative Site | Bordeaux | 33076 | France |
| Novartis Investigative Site | Lille | 59020 | France |
| Novartis Investigative Site | Saint-Herblain Cédex | 44805 | France |
| Novartis Investigative Site | Thonon-les-Bains | 74203 | France |
| Novartis Investigative Site | Villejuif | 94805 | France |
| Novartis Investigative Site | Győr | Hungary | H-9023 | Hungary |
| Novartis Investigative Site | Budapest | 1134 | Hungary |
| Novartis Investigative Site | Budapest | 1145 | Hungary |
| Novartis Investigative Site | Budapest | H-1083 | Hungary |
| Novartis Investigative Site | Debrecen | 4032 | Hungary |
| Novartis Investigative Site | Szeged | H-6720 | Hungary |
| Novartis Investigative Site | Szolnok | H-5000 | Hungary |
| Novartis Investigative Site | Province of Macerata | MC | 62100 | Italy |
| Novartis Investigative Site | Parma | PR | 43100 | Italy |
| Novartis Investigative Site | Sondrio | SO | 23100 | Italy |
| Novartis Investigative Site | Maastricht | 6229 HX | Netherlands |
| Novartis Investigative Site | Rotterdam | 3075 EA | Netherlands |
| Novartis Investigative Site | Surquillo | Lima region | 34 | Peru |
| Novartis Investigative Site | Poznan | 60-569 | Poland |
| Novartis Investigative Site | Rzeszów | 35-021 | Poland |
| Novartis Investigative Site | Warsaw | 02-781 | Poland |
| Novartis Investigative Site | Warsaw | 03-291 | Poland |
| Novartis Investigative Site | Warsaw | 04-125 | Poland |
| Novartis Investigative Site | Ryazan | Russia | 390011 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197758 | Russia |
| Novartis Investigative Site | Cape Town | 7500 | South Africa |
| Novartis Investigative Site | Parktown | 2193 | South Africa |
| Novartis Investigative Site | Port Elizabeth | 6045 | South Africa |
| Novartis Investigative Site | Toledo | Castille-La Mancha | 45071 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Madrid | Madrid | 28007 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46010 | Spain |
| Novartis Investigative Site | Taichung | Taichung | 407 | Taiwan |
| Novartis Investigative Site | Niaosong Township | Taiwan | 83301 | Taiwan |
| Novartis Investigative Site | Taipei | Taiwan | 10048 | Taiwan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set (FAS): Consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum to which they were assigned at randomization.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fulvestrant + Dovitinib Active | Fulvestrant in combination with the study drug Dovitinib. |
| BG001 | Fulvestrant + Dovitinib Placebo | Fulvestrant in combination with a placebo matching Dovitinib. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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) Based on Local Investigator Assessment | PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause and was assessed based on RECIST v1.1. Responses include: Complete Response: Disappearance of all non-nodal target lesions; Partial Response: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; Progressive Disease: At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline; Stable Disease: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline. | Full Analysis Set (FAS): Consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum to which they wereassigned at randomization. | Posted | Median | 95% Confidence Interval | Months | Every 8 weeks assessed up to 34 months |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | ORR was defined as the percentage of patients with a best overall response of Complete Response (CR) or Partial Response (PR) as per RECIST v1.1. Responses include: Complete Response: Disappearance of all non-nodal target lesions; Partial Response: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; Progressive Disease: At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline; Stable Disease: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline. | Full Analysis Set (FAS): Consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum to which they were assigned at randomization. | Posted | Number | 95% Confidence Interval | Percentage of participants | Every 8 weeks assessed up to 34 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR was defined as time from the date of the first documented response (CR or PR) to the date of the first documented or death due to disease. If a patient does not have a progression event, DOR will be censored on the date of the last adequate tumor assessment. | This outcome measure was not analyzed as the study was terminated before duration of response could be analyzed. | Posted | From date of first documented efficacy response (CR or PR) to time of documented progression (PD) whichever comes first, assessed up to 24 months |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) Using Kaplan- Meier Method | OS was defined as the time from the date of randomization to the date of death from any cause. If a patient is not known to have died at the date of analysis cut-off, the OS will be censored at the last date of contact. | Full Analysis Set (FAS): Consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum to which they were assigned at randomization. | Posted | Median | 95% Confidence Interval | Months | From date of randomization to date of death from any cause whichever comes first, assessed up to 34 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events as a Measure of Safety | The type, frequency and severity of adverse events, laboratory values, and Electrocardiograms (ECGs) experienced by patients will be assessed according to Common Terminology Criteria for Adverse Events. The study enrollment was terminated early due to challenges in enrolling patients with FGF amplified status. See safety section for safety details. | Safety Set: Consisted of all patients who received at least one dose of any compound of the study treatment (dovitinib +fulvestrant or placebo+fulvestrant). Patients were analyzed according to the actual study treatment received. Actual treatment received was defined as the treatment the patient received at the first day of study medication. | Posted | Number | Participants | Screening, Week 2, Week 4 and approximately every 4 weeks during treatment period (approximately 34 months) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Time to Worsening of ECOG Performance Status | Eastern Cooperative Oncology Group (ECOG) Performance Status (scales and criteria used by doctors and researchers to assess how a patient's disease is progressing and assess how the disease affects the daily living abilities of the patient.) | This outcome measure was not analyzed as the study was terminated before time to worsening ECOG performance could be analyzed. | Posted | Screening, Every 4 weeks during treatment period, and every 8 weeks during follow-up (approximately 9-12 months) |
|
|
Not provided
Not provided
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 | Fulvestrant + Dovitinib Active | Fulvestrant in combination with the study drug Dovitinib. | 14 | 47 | 47 | 47 | ||
| EG001 | Fulvestrant + Dovitinib Placebo | Fulvestrant in combination with a placebo matching Dovitinib. | 10 | 50 | 45 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| LUMBAR HERNIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| OESOPHAGEAL VARICES HAEMORRHAGE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| VARICES OESOPHAGEAL | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| DEVICE BREAKAGE | General disorders | MedDRA | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA | Systematic Assessment |
| |
| HYPERPYREXIA | General disorders | MedDRA | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA | Systematic Assessment |
| |
| BILE DUCT OBSTRUCTION | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| TOOTH ABSCESS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| SPINAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| CERVIX CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| ISCHAEMIC CEREBRAL INFARCTION | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| LARYNGOSPASM | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PIGMENTATION DISORDER | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA | Systematic Assessment |
| |
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA | Systematic Assessment |
| |
| PERIPHERAL ARTERY THROMBOSIS | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| EAR PAIN | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| DRY EYE | Eye disorders | MedDRA | Systematic Assessment |
| |
| LACRIMATION INCREASED | Eye disorders | MedDRA | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| LIPASE INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA | Systematic Assessment |
| |
| WEIGHT INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPERTRIGLYCERIDAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| SPINAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| AGEUSIA | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| HOT FLUSH | Vascular disorders | MedDRA | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | trialandresults.registries@novartis.com |
| 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 |
|---|---|
| C500007 | 4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one |
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
| Male |
|
| FGF non-amplified patients (n: 21, 25) |
|
|
|
|
| Participants |
|
|