An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer (VIRGO) (VIRGO)
8. června 2017 aktualizováno: Genentech, Inc.
An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer
This is a multicenter, prospective observational cohort study (OCS) designed to follow patients with locally recurrent or metastatic breast cancer in the United States. Two cohorts will be included:
- Patients with human epidermal growth factor receptor 2-negative (HER2-negative) disease receiving their first cytotoxic chemotherapy and/or targeted therapy (approximately 825 patients)
- Patients with hormone receptor-positive (HR-positive) disease receiving their first hormonal therapy for advanced disease (approximately 425 patients)
Patients who have received any chemotherapy for advanced disease more than 8 weeks prior to enrollment to this OCS will not be eligible. A total of approximately 1,250 patients will be enrolled. Approximately 150 study sites will be activated in order to achieve complete enrollment by December 2010.
Přehled studie
Postavení
Dokončeno
Podmínky
Typ studie
Pozorovací
Zápis (Aktuální)
1287
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
Breast cancer clinic
Popis
Inclusion Criteria:
- Signed Informed Consent Form
- Locally recurrent or metastatic breast cancer
- Receipt of first systemic cytotoxic chemotherapy and/or targeted therapy among those with HER2-negative disease or first hormone therapy among those with HR-positive disease for the treatment of locally recurrent or metastatic disease, within 8 weeks prior to enrollment
Exclusion Criteria
- Any medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to provide informed consent or comply with the treatment
- Any prior chemotherapy started more than 8 weeks prior to enrollment for the treatment of locally recurrent or for metastatic breast cancer
- Concurrent participation only in a blinded clinical trial
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Chemotherapy Cohort
Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
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Hormonal Therapy Cohort
Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Progression Free Survival
Časové okno: Approximately 4.5 years
|
Progression free survival was defined as the time from enrollment to progression or death of any cause, whichever came first.
The disease response status was assessed by the investigator according to the method of his or her choice.
The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method.
|
Approximately 4.5 years
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Overall Survival
Časové okno: Approximately 4.5 years
|
Overall survival was defined as the time from enrolment to death of any cause.
|
Approximately 4.5 years
|
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Number of Participants With Tumor Response
Časové okno: Approximately 4.5 years
|
The tumor response was measured as complete response, partial response, stable disease, progressive disease, or clinical deterioration based on their best overall response.
The tumor response was assessed by the investigator according to the method of his or her choice.
The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method.
|
Approximately 4.5 years
|
|
Number of Hormone Receptor-positive Participants Who Initiated Cytotoxic Chemotherapy Following Discontinuation
Časové okno: Approximately 4.5 years
|
Participants were assessed quarterly for progressive events and treatment status.
|
Approximately 4.5 years
|
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Number of Participants With Any Adverse Events, Any Serious Adverse Events, Any AEs Leading to Early Treatment Discontinuation, and Adverse Events Leading to Hospitalization or Death
Časové okno: Approximately 4.5 years
|
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
An Serious Adverse Events (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
|
Approximately 4.5 years
|
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Number of Participants With Arterial Thromboembolic Events, Venous Thromboembolic Events, Left Ventricular Systolic Dysfunction, and Peripheral Neuropathy
Časové okno: Approximately 4.5 years
|
All AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 as Grade 1 (mild), Graded 2 (moderate), Grade 3 (severe), Grade 4 (very severe, life threatening, or disabling), and Grade 5 (death related to AE).
Venous Thromboembolic Events (VTEs) included all Grade 4 or of more severity of deep vein thrombosis, pulmonary embolus; Arterial Thromboembolic Events (ATEs) Included new or worsening angina pectoris, myocardial infarction, stroke, transient ischemic attack, peripheral arterial ischemia of any NCI CTCAE grade; Left Ventricular Systolic Dysfunction (LVSD) included congestive heart failure) of NCI CTCAE Grade 2 or of more severity; Peripheral Neuropathy (PN) included sensory and/or motor events of Grade 3 or of more severity.
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Approximately 4.5 years
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. června 2008
Primární dokončení (Aktuální)
1. prosince 2012
Dokončení studie (Aktuální)
1. prosince 2012
Termíny zápisu do studia
První předloženo
30. července 2008
První předloženo, které splnilo kritéria kontroly kvality
30. července 2008
První zveřejněno (Odhad)
1. srpna 2008
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
11. července 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
8. června 2017
Naposledy ověřeno
1. června 2017
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- AVF4349n
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