Project Charter
Name of Project: Breast
October 31, 2014
Cancer Therapeutic Area Data Standards
Project Manager: Pam Harvey (pharvey@cdisc.org)
1. Project Team Members
All team members currently identified are listed in a separate roster, which will be maintained in the CDISC
Portal, to accommodate changes over time.
2. Estimated Number of Active Project Team Members
The TA standards development process is a complex process that requires the collaboration of many groups to
succeed. The table below illustrates the core participants who will be active and engaged within this project. The
roles of each member are defined in the Therapeutic Area Standards Development Process Guidelines. Existing
standards team members will serve as liaisons to the project.
Active Team Members by Role









Project Manager
Clinical Therapeutic Area Experts
Medical Writer
Statisticians
Metadata Developers
CDASH liaisons
ADaM liaisons
SDS liaisons
Terminology Expert
Total
Number of
Participants
1
3
1
5
13
2
3
3
1
32
Note that both program level and project level support will be needed for the life of the TA Standards
Development Program as envisioned by the CFAST committee. See the breast cancer project team roster on the
CDISC portal.
3. Document Repository Location
Project documents will be maintained in CDISC’s SharePoint Breast Cancer TA project area in the CDISC portal
accessible to all team members
4. Key Sponsors and Participants:
Current key participants are shown below. The project may invite participation of relevant medical associations.
Other key participants will be added as they are identified.
Stakeholder/Participant
CFAST Therapeutic Area Standards Steering Committee
QuantumLeap Healthcare Collaborative, I-SPY Network,
UCSF
Role
Program governance and resource allocation.
Subject matter expert consultation.
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Stakeholder/Participant
TransCelerate BioPharma
FDA
NCI EVS
CDISC Teams: BRIDG, CDASH, SDS, Terminology,
and ADaM
Role
Provides clinical expertise, team members, and
reviewers recruited through member companies.
Consults on scoping and performs review of draft and
final documents.
Supports the development, maintenance, and
publication of all CDISC terminology for each project.
Project liaisons to support the TA standards
development resources.
5. Project Description/Scope
The Breast Cancer Therapeutic Area Standards project is being performed under the CFAST initiative to
accelerate clinical research and medical product development by facilitating the creation and maintenance of data
standards, tools, and methods for conducting research in therapeutic areas important to public health.
The project was originally scoped to achieve its deliverables within a time frame of 10-12 months as agreed by
CFAST. This includes data from neoadjuvant, adjuvant, and metastatic trials that are used in analyses and
submissions to the FDA for therapeutic drug evaluation.
In Scope for Project Deliverables:
Type of Data
Estimated
Magnitude
Gaps
Y/N
Gap Analysis
Subject and Disease Characteristics
Disease Diagnosis
Typical
N
Major Comorbid Conditions
Typical
N
Family History
Typical
N
Pathology
Large
Y
Breast Cancer Staging
Small
Y
Medium
Y
Will model similar to other TAs. This includes
“event types” (start dates) of interest, as well as
diagnosis terminology.
The Medical History domain will handle this
concept.
The SMEs will explain relevant family history.
The Associated Persons implementation guide
will handle these data.
~20 assessments are performed on tissue
specimens. Relevant domains are present in
SDTM, but not in CDASH.
Terminology development will draw on existing
CDISC and caDSR sources.
8 clinical and pathologic staging concepts.
SMEs have suggested modeling these using the
proposed clinical classification SDTM domain.
SDTM domain decisions, test names and
terminology needed.
~7 genetic, gene expression, and
histopathology tests. SDTM domain decisions
and terminology needed.
Medium
Y
May need to handle total cumulative dose.
Pathological assessments are conducted on
surgical tissue. SDTM domain decisions and
terminology needed.
Typical
Y
SDTM oncology domains exist, but a new
variable is being proposed to handle “lesions”
such as ascites and pleural effusion.
Biomarkers
Disease Management and Assessments
Treatments
 Endocrine
 Chemotherapy
 Radiation
 Surgery
Tumor Identification and Assessment
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Type of Data
Estimated
Magnitude
Small
Gaps
Y/N
N
Small
Y
Routine Data
Treatment Side Effects
Small
Y
Concomitant Meds
Small
Y
Vital Signs
Typical
N
Disposition
Typical
N
Estimated
Magnitude
Gaps
Y/N
Overall Survival
Disease-Free Survival
Event-Free Survival
Progression-Free Survival
Typical
Y
Time-to-event is covered in ADaM. Will need
to configure this for Breast Cancer.
Pathologic Complete Response
Medium
Y
Will need to assess and model according to
published regulatory guidance. Pathology
(subset assessing presence of cancer)
Survival status
Cardiac Function Tests
 MUGA, ECHO, ECG
Analysis Endpoints
Type of Endpoints
Gap Analysis
The Survival Status domain will handle this
concept.
The SMEs will explain the relevance of Left
Ventricular Ejection Fraction (LVEF) and QT
prolongation in this TA. LVEF test code exists,
but need SDTM domain decision. May require
extensions to the cardiovascular physiology
domain and coordination with proposed CV
Imaging project.
May need to handle flagging AEs for dose
limiting toxicities or suspected unexpected
serious adverse reactions.
Will need examples for proposed variable
'reason treatment discontinued.' Terminology
development will require coordination with
other TA projects.
Height, weight and BMI are used in dosing of
some treatments. The Vital Signs domain will
handle these concepts, when needed.
Date of randomization is used in time-to-event
analysis endpoints. Existing domains will
handle this concept.
Gap Analysis
6. References
References consulted included relevant NIH, FDA, EMA guidance, literature and NCI Breast Oncology Local
Disease (BOLD) data standards. A complete list of references can be found on the CDISC team portal.
7. Project Deliverables
Therapeutic Area Standards User Guide (TAUG) that will include:
 Essential core research concepts with definitions, data types (simple & ISO 21090) and SDTM mappings
 Concept maps of disease area research concepts
 CDASH metadata for selected research concepts
 Selected annotated CRFs (with CDASH and SDTM-based annotations)
 SDTM examples, as appropriate
 Minimum terminology value sets (code lists) with definitions and C-Codes, as appropriate
 Analysis guidelines:
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 Identification of the data needed for endpoint derivations, but not the actual statistical analyses of
endpoints.
 Description of how the clinical endpoints translate into statistical endpoints.
 Examples of ADaM compliant analysis datasets.
 Selected example table shells/figures and illustrations (via analysis results metadata) of the crosswalk
from the ADaM dataset(s) to the analysis.
Project deliverables will reference sources and describe provenance used in their creation.
8. Project Milestones
The project will follow the enhanced therapeutic area standards development process. Following is a high-level
project plan.
Project
Stage
Process Phase
Timeline
(Target Completion)
Stage 0
Start of Breast Cancer Project
(project charter approval)
Provisional: June 2014
Final: October 2014
Stage 1
Modeling of Research Concepts
Q4 2014
Stage 2
Standards Development
Q4 2014
Internal Review
Q1 2015
Public Review
Late Q1-Q2 2015
Public Release
Q2 2015
Stage 3
More detailed dates and milestones will be maintained in a separate Breast Cancer project plan.
9. Project Resources
 Members in project level roles are recruited for the therapeutic area project. Members in program level roles
generally participate in the work of multiple therapeutic area projects and provide expert advice and direction
for all TA project teams; these members may also be liaisons to CDISC foundational standards teams.
Reviewers are also recruited for the particular therapeutic area project and participate in review of
deliverables as designated within the project development stage.
10. Gaps, Risks, Complexities and Challenges
 A major potential risk to this ambitious project plan is resource availability. For this project to succeed,
assigned resources must continue be made available to work on project deliverables. It is critical that
personnel assigned are able to prioritize the project above other responsibilities. This project remains
dependent, to a large extent, on volunteer engagement beyond the resources assigned by TransCelerate
BioPharma Inc. (TCB).
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
Project Complexity is rated as high, with an unusually large team, which will increase management
challenges and coordination. This project is the first oncology therapeutic area to be developed and as such,
much of the common oncology data will be developed as part of this project.

Project Challenges: the following challenges were encountered, which caused delays in completing the
scoping and charter approval phase of the standards development activities on the project:
May – Assigned a new project manager
June to August – resolution of FDA attribution concerns and delayed receipt of FDA requirements
document.
June – ongoing - NCI caDSR database search had to be redone; results (over 500 records) much more
extensive than for previous TA projects. Continue to work on the final list of in-scope BrCa concepts

Proposed v2 Content and Rationale
o Due to the timelines of this project 'Patient Reported Outcomes' / 'Questionnaires' will be deferred to
V2.
11. Literature Review
A complete list of relevant guidance's, articles and publications for this indication can be found on the CDISC
team portal.

ASCO breast cancer guidelines: http://www.asco.org/quality-guidelines/guidelines

EMA The role of the pathological Complete Response as an endpoint in neoadjuvant breast cancer studies
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/04/WC500165781.pdf

ESMO guidelines: http://www.esmo.org/Guidelines-Practice/Clinical-Practice-Guidelines/Breast-Cancer

AJCC guidelines: Edge SB, Byrd DR, Compton CC, Fritz AG, Greene FL, Trotti A, editors. AJCC cancer staging
manual (7th ed). New York, NY: Springer; 2010.

CAP guidelines:
http://www.cap.org/apps/cap.portal?_nfpb=true&cntvwrPtlt_actionOverride=%2Fportlets%2FcontentViewer%2Fsh
ow&_windowLabel=cntvwrPtlt&cntvwrPtlt{actionForm.contentReference}=committees%2Fcancer%2Fcancer_prot
ocols%2Fprotocols_index.html&_state=maximized&_pageLabel=cntvwr

NCCN guidelines: www.nccn.org/professionals/physician_gls/PDF/breast.pdf

FDA Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an
Endpoint to Support Accelerated Approval:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM305501.pdf
12. Related Documents
o The Breast Cancer Team Member List (to be updated as required throughout the project)
o The Breast Cancer Scoping & Input Concepts Listing (Excel)
o The Breast Cancer Scoping & Input Checklist
o The Breast Cancer Project Plan
13. Date Approved: October 30, 2014