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The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SU011248/Trastuzumab | Drug | SU011248 will be administered orally, starting dose of 37.5 mg daily on a continuous regimen. Trastuzumab will be administered weekly (loading dose 4 mg/kg followed by weekly 2mg/kg) or every 3 weeks (loading dose 8 mg/kg followed by 6mg/kg q3w). Study treatment should continue until progression, withdrawal for other reasons, or for up to 18 months following which patients requiring continued access will be offered SU011248 on a separate protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Overall Confirmed Objective Disease Response | Objective disease response =participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target and non-target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions associated to a non-progressive disease response for the non target lesions. | From start of treatment through 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DR) | Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of objective tumor progression or death due to any cause. If tumor progression data included more than 1 date, the first date was used. DR was calculated as (the end date for DR minus first CR or PR that was subsequently confirmed +1) divided by 7. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Montgomery | Alabama | 36106 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24606768 | Derived | Bachelot T, Garcia-Saenz JA, Verma S, Gutierrez M, Pivot X, Kozloff MF, Prady C, Huang X, Khosravan R, Wang Z, Cesari R, Tassell V, Kern KA, Blay JY, Lluch A. Sunitinib in combination with trastuzumab for the treatment of advanced breast cancer: activity and safety results from a phase II study. BMC Cancer. 2014 Mar 7;14:166. doi: 10.1186/1471-2407-14-166. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Trastuzumab + Sunitinib | Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| From start of treatment through 18 months |
| Percentage of Participants With Clinical Benefit | Percent of participants with confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST.CR was defined as disappearance of all target and non-target lesions.PR was defined as >=30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions associated to non-progressive disease response for non target lesions.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started. | From start of treatment through 18 months |
| Progression Free Survival (PFS) | Time from first dose of study treatment to first documentation of objective tumor progression, or to death on-study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was calculated as (first event date minus first dose date +1) divided by 7. | From start of treatment through 18 months |
| Time to Progression (TTP) | Time from first dose of study treatment to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP was calculated as (first event date minus first dose date +1) divided by 7. | From start of treatment through 18 months |
| Overall Survival (OS) | Time from first dose of study treatment to first documentation of death due to any cause. OS was calculated as (date of death minus first dose date +1) divided by 7 * 4.33. | From start of study treatment until death or 2 years from first study treatment |
| Probability of Survival at One Year | One- year survival probability was estimated using the Kaplan-Meier method. | From start of study treatment until death or 2 years from first study treatment |
| EORTC QLQ-C30 | EORTC QLQ-C30 scales consist of 30 questions: functional (physical/role/cognitive/emotional/ social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea). Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent. Scales/single-items averaged, score 0 to 100. Higher functional/global=better functioning and symptom=greater degree of symptoms. | From start of treatment through 18 months |
| EORTC QLQ (BR23) | BR23: consisted of 23 questions which measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms. | From start of treatment through 18 months |
| Dose-corrected Trough Plasma Concentrations (Ctrough) of Sunitinib | Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg. | Predose on Day 1 of Cycle 3 and 5 |
| Dose-corrected Ctrough of SU-012662 (Sunitinib's Metabolite) | Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg. | Predose on Day 1 of Cycle 3 and 5 |
| Dose-corrected Ctrough of Total Drug (Sunitinib + SU-012662) | Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg. | Predose on Day 1 of Cycle 3 and 5 |
| Newark |
| Delaware |
| 19713 |
| United States |
| Pfizer Investigational Site | Newark | Delaware | 19718-6001 | United States |
| Pfizer Investigational Site | Wilmington | Delaware | 19899 | United States |
| Pfizer Investigational Site | Fort Lauderdale | Florida | 33308 | United States |
| Pfizer Investigational Site | Harvey | Illinois | 60426 | United States |
| Pfizer Investigational Site | Tinley Park | Illinois | 60477 | United States |
| Pfizer Investigational Site | Munster | Indiana | 46321 | United States |
| Pfizer Investigational Site | Lafayette | Louisiana | 70503 | United States |
| Pfizer Investigational Site | New Iberia | Louisiana | 70563 | United States |
| Pfizer Investigational Site | Corinth | Mississippi | 38834 | United States |
| Pfizer Investigational Site | Southaven | Mississippi | 38671 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89135 | United States |
| Pfizer Investigational Site | New York | New York | 10021 | United States |
| Pfizer Investigational Site | Memphis | Tennessee | 38104 | United States |
| Pfizer Investigational Site | Memphis | Tennessee | 38120 | United States |
| Pfizer Investigational Site | Ottignies | 1340 | Belgium |
| Pfizer Investigational Site | Wilrijk | 2610 | Belgium |
| Pfizer Investigational Site | Toronto | Ontario | M4N 3M5 | Canada |
| Pfizer Investigational Site | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H3G 1A4 | Canada |
| Pfizer Investigational Site | Besançon | 25030 | France |
| Pfizer Investigational Site | Lyon | 69373 | France |
| Pfizer Investigational Site | Saint-Cloud | 92210 | France |
| Pfizer Investigational Site | Barcelona | Barcelona | 08003 | Spain |
| Pfizer Investigational Site | Madrid | Madrid | 28040 | Spain |
| Pfizer Investigational Site | Valencia | Valencia | 46010 | Spain |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Trastuzumab + Sunitinib | Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles. |
| 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 |
| |||||||||||||||||||||
| EORTC QLQ-C30 | European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30).Response range:not at all-very much,global/QOL range:very poor-excellent.Scale/single-item-score 0-100.Higher functional/global=better functioning and symptom=greater degree of symptoms.'n' = participants evaluated at timepoint for each group. | Mean | Standard Deviation | scores on a scale |
| |||||||||||||||||||
| EORTC QLQ Breast Cancer Module (BR23) | EORTC QLQ (BR23): consist of 23 questions. Response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively. | Mean | Standard Deviation | scores on a scale |
|
| 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 | Percentage of Participants With Overall Confirmed Objective Disease Response | Objective disease response =participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target and non-target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions associated to a non-progressive disease response for the non target lesions. | The intent-to-treat (ITT) population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib). | Posted | Number | 95% Confidence Interval | percentage of participants | From start of treatment through 18 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Duration of Response (DR) | Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of objective tumor progression or death due to any cause. If tumor progression data included more than 1 date, the first date was used. DR was calculated as (the end date for DR minus first CR or PR that was subsequently confirmed +1) divided by 7. | DR was calculated for the subgroup of participants from the ITT set, with a confirmed objective tumor response. | Posted | Median | 95% Confidence Interval | weeks | From start of treatment through 18 months |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Benefit | Percent of participants with confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST.CR was defined as disappearance of all target and non-target lesions.PR was defined as >=30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions associated to non-progressive disease response for non target lesions.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started. | The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib). | Posted | Number | 95% Confidence Interval | Percentage of Participants | From start of treatment through 18 months |
|
| ||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | Time from first dose of study treatment to first documentation of objective tumor progression, or to death on-study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was calculated as (first event date minus first dose date +1) divided by 7. | The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib). | Posted | Median | 95% Confidence Interval | Weeks | From start of treatment through 18 months |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) | Time from first dose of study treatment to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP was calculated as (first event date minus first dose date +1) divided by 7. | The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib). | Posted | Median | 95% Confidence Interval | weeks | From start of treatment through 18 months |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Time from first dose of study treatment to first documentation of death due to any cause. OS was calculated as (date of death minus first dose date +1) divided by 7 * 4.33. | The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib). | Posted | Median | 95% Confidence Interval | months | From start of study treatment until death or 2 years from first study treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Probability of Survival at One Year | One- year survival probability was estimated using the Kaplan-Meier method. | The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib). | Posted | Number | 95% Confidence Interval | percentage of 1-year survival | From start of study treatment until death or 2 years from first study treatment |
|
| ||||||||||||||||||||||||||
| Secondary | EORTC QLQ-C30 | EORTC QLQ-C30 scales consist of 30 questions: functional (physical/role/cognitive/emotional/ social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea). Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent. Scales/single-items averaged, score 0 to 100. Higher functional/global=better functioning and symptom=greater degree of symptoms. | The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively. | Posted | Mean | Standard Deviation | scores on a scale | From start of treatment through 18 months |
|
| ||||||||||||||||||||||||||
| Secondary | EORTC QLQ (BR23) | BR23: consisted of 23 questions which measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms. | The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively. | Posted | Mean | Standard Deviation | scores on a scale | From start of treatment through 18 months |
|
| ||||||||||||||||||||||||||
| Secondary | Dose-corrected Trough Plasma Concentrations (Ctrough) of Sunitinib | Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg. | The Pharmacokinetic (PK) population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib) and collected plasma values. | Posted | Mean | Standard Deviation | nanograms (ng)/milliliter (mL) | Predose on Day 1 of Cycle 3 and 5 |
|
| ||||||||||||||||||||||||||
| Secondary | Dose-corrected Ctrough of SU-012662 (Sunitinib's Metabolite) | Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg. | The PK population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib) and collected plasma values. | Posted | Mean | Standard Deviation | ng/mL | Predose on Day 1 of Cycle 3 and 5 |
|
| ||||||||||||||||||||||||||
| Secondary | Dose-corrected Ctrough of Total Drug (Sunitinib + SU-012662) | Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg. | The PK population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib) and collected plasma values. | Posted | Mean | Standard Deviation | ng/mL | Predose on Day 1 of Cycle 3 and 5 |
|
|
From time of informed consent signing (SAEs) or first study treatment (AEs) through 18 months and including 28 calendar days after the last dose of study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trastuzumab + Sunitinib | Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles. | 25 | 60 | 59 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Oesophageal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Drug interaction | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hair colour changes | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Yellow skin | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.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 |
|---|---|
| D000077210 | Sunitinib |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
|
| Function Score: Role function (n=49) |
|
| Function Score: Cognitive function (n=49) |
|
| Function Score: Emotional function (n=49) |
|
| Function Score: Social function (n=49) |
|
| Symptom Score: Fatigue (n=49) |
|
| Symptom Score: Pain (n=49) |
|
| Symptom Score: Nausea/vomiting (n=49) |
|
| Symptom Score: Dyspnea (n=48) |
|
| Symptom Score: Loss of appetite (n=49) |
|
| Symptom Score: Insomnia (n=49) |
|
| Symptom Score: Constipation (n=48) |
|
| Symptom Score: Diarrhea (n=49) |
|
| Symptom Score: Financial difficulty (n=48) |
|
|
| Function Score: Sexual enjoyment (n=15) |
|
| Symptom Score: Arm (n=48) |
|
| Symptom Score: Breast (n=47) |
|
| Symptom Score: systemic therapy side effects(n=48) |
|
| Others :Upset of hair loss (n=6) |
|
| Others :Future health perspective (n=48) |
|
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