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Models to select chemotherapy, endocrine therapy or biologic agent to advance to phase III trials for advanced breast cancer
Descriptive
TitleInfo
Title
Models to select chemotherapy, endocrine therapy or biologic agent to advance to phase III trials for advanced breast cancer
Name
(type = personal)
NamePart
(type = family)
Chen
NamePart
(type = given)
Xinqun
NamePart
(type = date)
1971-
DisplayForm
Xinqun Chen
Role
RoleTerm
(authority = RULIB)
author
Name
(type = personal)
NamePart
(type = family)
Shih
NamePart
(type = given)
Weichung Joe
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Weichung Joe Shih
Affiliation
Advisory Committee
Role
RoleTerm
(authority = RULIB)
chair
Name
(type = personal)
NamePart
(type = family)
Moore
NamePart
(type = given)
Dirk
DisplayForm
Dirk Moore
Affiliation
Advisory Committee
Role
RoleTerm
(authority = RULIB)
internal member
Name
(type = personal)
NamePart
(type = family)
Ohman-Strickland
NamePart
(type = given)
Pamela
DisplayForm
Pamela Ohman-Strickland
Affiliation
Advisory Committee
Role
RoleTerm
(authority = RULIB)
internal member
Name
(type = personal)
NamePart
(type = family)
Wong
NamePart
(type = given)
Serena
DisplayForm
Serena Wong
Affiliation
Advisory Committee
Role
RoleTerm
(authority = RULIB)
outside member
Name
(type = corporate)
NamePart
Rutgers University
Role
RoleTerm
(authority = RULIB)
degree grantor
Name
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NamePart
School of Public Health
Role
RoleTerm
(authority = RULIB)
school
TypeOfResource
Text
Genre
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theses
OriginInfo
DateCreated
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2015
DateOther
(qualifier = exact);
(type = degree)
2015-05
CopyrightDate
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2015
Place
PlaceTerm
(type = code)
xx
Language
LanguageTerm
(authority = ISO639-2b);
(type = code)
eng
Abstract
(type = abstract)
In order to improve the success rate of oncology phase III trials giving promising results in previous phase II studies, the Exponential-Gamma statistical model based on Bayesian framework is adopted and applied into the oncology drug trial for patients with the advanced breast cancer to provide insight of the likelihood that experimental regimen will provide a clinical benefit such as prolongation of survival compared with standard therapy in subsequent phase III clinical trials to make a phase III go/no go decision. The Bayesian statistical model is a hybrid Bayesian/frequentist approach where the phase III test is still in the classical (frequentist) framework, and the preceding phase II or phase III studies are used to evaluate the probability of success of such a phase III test by a Bayesian approach. The information extracted from advanced breast cancer clinical trials from 1990 to 2012 and survival data from phase II or III studies of the experimental and control regimens are used to model the survival hazard distributions for the two regimens. In addition, the existing statistical method is expanded to include two new models, the Weibull-Inverse Gamma model and Piece-wise Exponential model to derive the expected power. We study and explore retrospectively the consistence and inconsistence between calculated expected powers and the significance of actual subsequent phase III study results with endpoints of progression free survival and overall survival, and evaluate the validity of the expected power model in predicting the likelihood of successful phase III trials. Based on our experience in advanced breast cancer, an expected power of greater than 0.59 with the Exponential-Gamma model, and of greater than 0.64 with the Weibull-Inverse Gamma model provide a reasonable base to proceed to a phase III study. However, due to limitation of data, we cannot evaluate the validity of the Piece-wise Exponential method, nor provide suggestion of cut-off value of expected power for later phase III studies.
Subject
(authority = RUETD)
Topic
Public Health
Subject
(authority = ETD-LCSH)
Topic
Breast--Cancer--Treatment
Subject
(authority = ETD-LCSH)
Topic
Clinical trials
Subject
(authority = ETD-LCSH)
Topic
Bayesian statistical decision theory
RelatedItem
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TitleInfo
Title
Rutgers University Electronic Theses and Dissertations
Identifier
(type = RULIB)
ETD
Identifier
ETD_6258
PhysicalDescription
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electronic resource
InternetMediaType
application/pdf
InternetMediaType
text/xml
Extent
1 online resource (xiv, 124 p. : ill.)
Note
(type = degree)
Dr.P.H.
Note
(type = bibliography)
Includes bibliographical references
Note
(type = vita)
Includes vita
Note
(type = statement of responsibility)
by Xinqun Chen
RelatedItem
(type = host)
TitleInfo
Title
School of Public Health ETD Collection
Identifier
(type = local)
rucore10007500001
Location
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(displayLabel = Rutgers, The State University of New Jersey)
NjNbRU
Identifier
(type = doi)
doi:10.7282/T3BK1F8D
Genre
(authority = ExL-Esploro)
ETD doctoral
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Rights
RightsDeclaration
(ID = rulibRdec0006)
The author owns the copyright to this work.
RightsHolder
(type = personal)
Name
FamilyName
Chen
GivenName
Xinqun
Role
Copyright Holder
RightsEvent
Type
Permission or license
DateTime
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(qualifier = exact);
(point = start)
2015-04-06 17:58:40
AssociatedEntity
Name
Xinqun Chen
Role
Copyright holder
Affiliation
Rutgers University. School of Public Health
AssociatedObject
Type
License
Name
Author Agreement License
Detail
I hereby grant to the Rutgers University Libraries and to my school the non-exclusive right to archive, reproduce and distribute my thesis or dissertation, in whole or in part, and/or my abstract, in whole or in part, in and from an electronic format, subject to the release date subsequently stipulated in this submittal form and approved by my school. I represent and stipulate that the thesis or dissertation and its abstract are my original work, that they do not infringe or violate any rights of others, and that I make these grants as the sole owner of the rights to my thesis or dissertation and its abstract. I represent that I have obtained written permissions, when necessary, from the owner(s) of each third party copyrighted matter to be included in my thesis or dissertation and will supply copies of such upon request by my school. I acknowledge that RU ETD and my school will not distribute my thesis or dissertation or its abstract if, in their reasonable judgment, they believe all such rights have not been secured. I acknowledge that I retain ownership rights to the copyright of my work. I also retain the right to use all or part of this thesis or dissertation in future works, such as articles or books.
RightsEvent
DateTime
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(qualifier = exact);
(point = start)
2015-05-31
DateTime
(encoding = w3cdtf);
(qualifier = exact);
(point = end)
2016-05-30
Type
Embargo
Detail
Access to this PDF has been restricted at the author's request. It will be publicly available after May 30th, 2016.
Copyright
Status
Copyright protected
Availability
Status
Open
Reason
Permission or license
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Technical
RULTechMD
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ContentModel
ETD
OperatingSystem
(VERSION = 5.1)
windows xp
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Statistical Profile