Journal ArticleDOI
I‐SPY 2: An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy
Anna D. Barker,Caroline C. Sigman,Gary J. Kelloff,Nola M. Hylton,Donald A. Berry,Laura J. Esserman +5 more
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I‐SPY 2 (investigation of serial studies to predict your therapeutic response with imaging and molecular analysis 2) is a process targeting the rapid, focused clinical development of paired oncologic therapies and biomarkers.Abstract:
I-SPY 2 (investigation of serial studies to predict your therapeutic response with imaging and molecular analysis 2) is a process targeting the rapid, focused clinical development of paired oncologic therapies and biomarkers. The framework is an adaptive phase II clinical trial design in the neoadjuvant setting for women with locally advanced breast cancer. I-SPY 2 is a collaborative effort among academic investigators, the National Cancer Institute, the US Food and Drug Administration, and the pharmaceutical and biotechnology industries under the auspices of the Foundation for the National Institutes of Health Biomarkers Consortium.read more
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Tumour heterogeneity in the clinic
Philippe L. Bedard,Aaron R. Hansen,Aaron R. Hansen,Mark J. Ratain,Lillian L. Siu,Lillian L. Siu +5 more
TL;DR: A large number of cancer cells with unique genomes in the same patient may exist across different geographical regions of a tumour or evolve over time, called intratumour heterogeneity, and Sequencing technologies can be used to characterize intratumours heterogeneity at diagnosis, monitor clonal dynamics during treatment and identify the emergence of clinical resistance during disease progression.
Journal ArticleDOI
Top 10 Challenges in Cancer Immunotherapy
Priti S. Hegde,Daniel S. Chen +1 more
TL;DR: Ten key challenges facing cancer immunotherapy are defined, which range from lack of confidence in translating pre-clinical findings to identifying optimal combinations of immune-based therapies for any given patient.
Journal ArticleDOI
Toil enables reproducible, open source, big biomedical data analyses
John Vivian,Arjun A. Rao,Frank Austin Nothaft,Christopher Ketchum,Joel Armstrong,Adam M. Novak,Jacob Pfeil,Jake Narkizian,Alden Deran,Audrey Musselman-Brown,Hannes Schmidt,Peter Amstutz,Brian Craft,Mary Goldman,Kate R. Rosenbloom,Melissa S. Cline,Brian O'Connor,Megan Hanna,Chet Birger,W. James Kent,David A. Patterson,Anthony D. Joseph,Jingchun Zhu,Sasha Zaranek,Gad Getz,David Haussler,Benedict Paten +26 more
TL;DR: It is envisage that in future individual research laboratories, or clusters of colocated laboratories, will have in-house, low-cost automation work cells but will access DNA foundries via the cloud to carry out complex experimental workflows and accelerate the development and sharing of standardized protocols and metrology standards.
Journal ArticleDOI
Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both
Janet Woodcock,Lisa M. LaVange +1 more
TL;DR: This review considers master protocols, which involve the study of one or more interventions in multiple diseases or of a single disease with multiple interventions.
Journal ArticleDOI
Adaptive Randomization of Veliparib–Carboplatin Treatment in Breast Cancer
Hope S. Rugo,Olufunmilayo I. Olopade,Angela DeMichele,Christina Yau,Laura J. van't Veer,Meredith Buxton,Michael Hogarth,Nola M. Hylton,Melissa Paoloni,Jane Perlmutter,W. Fraser Symmans,Douglas Yee,A. Jo Chien,Anne M. Wallace,Henry G. Kaplan,Judy C. Boughey,Tufia C. Haddad,Kathy S. Albain,Minetta C. Liu,Claudine Isaacs,Qamar J. Khan,Julie E. Lang,Rebecca K. Viscusi,Lajos Pusztai,Stacy L. Moulder,Stephen Y. Chui,Kathleen Kemmer,Anthony D. Elias,Kirsten K. Edmiston,David M. Euhus,Barbara Haley,Rita Nanda,Donald W. Northfelt,Debasish Tripathy,William C. Wood,Cheryl Ewing,Richard Schwab,Julia Lyandres,Sarah E. Davis,Gillian L. Hirst,Ashish Sanil,Donald A. Berry,Laura J. Esserman +42 more
TL;DR: The process used in the I-SPY 2 trial showed that veliparib-carboplatin added to standard therapy resulted in higher rates of pathological complete response than standard therapy alone specifically in triple-negative breast cancer.
References
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The price of innovation: new estimates of drug development costs
TL;DR: The research and development costs of 68 randomly selected new drugs were obtained from a survey of 10 pharmaceutical firms and used to estimate the average pre-tax cost of new drug development.
Journal ArticleDOI
Bayesian clinical trials
TL;DR: The rationale underlying Bayesian clinical trials is explained, the potential of such trials to improve the effectiveness of drug development is discussed, and the potential for smaller more informative trials and for patients to receive better treatment is discussed.
Journal ArticleDOI
Clinical application of the 70-gene profile: the MINDACT trial.
Fatima Cardoso,Laura J. van't Veer,Emiel J. Th. Rutgers,Sherene Loi,S. Mook,Martine Piccart-Gebhart +5 more
TL;DR: The 70-gene profile is a new prognostic tool that has the potential to greatly improve risk assessment and treatment decision making for early breast cancer and is currently ongoing through the MINDACT trial.
Journal ArticleDOI
Locally Advanced Breast Cancer.
TL;DR: Multidisciplinary therapy that includes primary chemotherapy provides appropriate local control and the possibility of breast conservation therapy; it increases surgical resectability and survival rates in patients with locally advanced breast cancer.
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