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I spy trial

Jeffrey I Campbell, Christina Yau, Polina Krass, Dan Moore, Lisa A Carey, Alfred Au, David Chhieng, Dilip Giri, Chad Livasy, Carolyn Mies, Joseph Rabban, Venetia R Sarode, Baljit Singh, Laura Esserman, Yunn-Yi Chen
PURPOSE: Several pathologic staging systems characterize residual tumor in patients undergoing neoadjuvant chemotherapy for breast cancer. Pathologic complete response (pCR) is now accepted by the Food and Drug Administration as an endpoint for granting accelerated drug approval. Two other systems of post-neoadjuvant pathologic tumor staging-residual cancer burden (RCB) and the American Joint Committee on Cancer post-neoadjuvant therapy staging system (yAJCC)-have been developed to characterize residual tumors when patients do not achieve pCR...
June 2, 2017: Breast Cancer Research and Treatment
Edward L Korn, Boris Freidlin
There is a wide range of adaptive elements of clinical trial design (some old and some new), with differing advantages and disadvantages. Classical interim monitoring, which adapts the design based on early evidence of superiority or futility of a treatment arm, has long been known to be extremely useful. A more recent application of interim monitoring is in the use of phase II/III designs, which can be very effective (especially in the setting of multiple experimental treatments and a reliable intermediate end point) but do have the cost of having to commit earlier to the phase III question than if separate phase II and phase III trials were performed...
June 1, 2017: Journal of the National Cancer Institute
Steffen Ventz, William T Barry, Giovanni Parmigiani, Lorenzo Trippa
We develop a general class of response-adaptive Bayesian designs using hierarchical models, and provide open source software to implement them. Our work is motivated by recent master protocols in oncology, where several treatments are investigated simultaneously in one or multiple disease types, and treatment efficacy is expected to vary across biomarker-defined subpopulations. Adaptive trials such as I-SPY-2 (Barker et al., 2009) and BATTLE (Zhou et al., 2008) are special cases within our framework. We discuss the application of our adaptive scheme to two distinct research goals...
February 17, 2017: Biometrics
Wen Li, Vignesh Arasu, David C Newitt, Ella F Jones, Lisa Wilmes, Jessica Gibbs, John Kornak, Bonnie N Joe, Laura J Esserman, Nola M Hylton
Functional tumor volume (FTV) measurements by dynamic contrast-enhanced magnetic resonance imaging can predict treatment outcomes for women receiving neoadjuvant chemotherapy for breast cancer. Here, we explore whether the contrast thresholds used to define FTV could be adjusted by breast cancer subtype to improve predictive performance. Absolute FTV and percent change in FTV (ΔFTV) at sequential time-points during treatment were calculated and investigated as predictors of pathologic complete response at surgery...
December 2016: Tomography: a Journal for Imaging Research
Lisa A Carey, Eric P Winer
No abstract text is available yet for this article.
July 7, 2016: New England Journal of Medicine
Hope S Rugo, Olufunmilayo I Olopade, Angela DeMichele, Christina Yau, Laura J van 't Veer, Meredith B 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 A Kemmer, Anthony D Elias, Kirsten K Edmiston, David M Euhus, Barbara B 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
BACKGROUND: The genetic and clinical heterogeneity of breast cancer makes the identification of effective therapies challenging. We designed I-SPY 2, a phase 2, multicenter, adaptively randomized trial to screen multiple experimental regimens in combination with standard neoadjuvant chemotherapy for breast cancer. The goal is to match experimental regimens with responding cancer subtypes. We report results for veliparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, combined with carboplatin...
July 7, 2016: New England Journal of Medicine
John W Park, Minetta C Liu, Douglas Yee, Christina Yau, Laura J van 't Veer, W Fraser Symmans, Melissa Paoloni, Jane Perlmutter, Nola M Hylton, Michael Hogarth, Angela DeMichele, Meredith B Buxton, A Jo Chien, Anne M Wallace, Judy C Boughey, Tufia C Haddad, Stephen Y Chui, Kathleen A Kemmer, Henry G Kaplan, Claudine Isaacs, Rita Nanda, Debasish Tripathy, Kathy S Albain, Kirsten K Edmiston, Anthony D Elias, Donald W Northfelt, Lajos Pusztai, Stacy L Moulder, Julie E Lang, Rebecca K Viscusi, David M Euhus, Barbara B Haley, Qamar J Khan, William C Wood, Michelle Melisko, Richard Schwab, Teresa Helsten, Julia Lyandres, Sarah E Davis, Gillian L Hirst, Ashish Sanil, Laura J Esserman, Donald A Berry
BACKGROUND: The heterogeneity of breast cancer makes identifying effective therapies challenging. The I-SPY 2 trial, a multicenter, adaptive phase 2 trial of neoadjuvant therapy for high-risk clinical stage II or III breast cancer, evaluated multiple new agents added to standard chemotherapy to assess the effects on rates of pathological complete response (i.e., absence of residual cancer in the breast or lymph nodes at the time of surgery). METHODS: We used adaptive randomization to compare standard neoadjuvant chemotherapy plus the tyrosine kinase inhibitor neratinib with control...
July 7, 2016: New England Journal of Medicine
David Harrington, Giovanni Parmigiani
No abstract text is available yet for this article.
July 7, 2016: New England Journal of Medicine
(no author information available yet)
The combination of the antibody-drug conjugate ado-trastuzumab emtansine, or T-DM1, plus pertuzumab given prior to surgery outperformed standard therapy in women with HER2-positive breast cancer enrolled in the I-SPY 2 trial. The results, reported at the American Association for Cancer Research Annual Meeting 2016, suggest that the drug combination would be successful in a phase III trial, potentially leading to an effective, less toxic treatment option for women at risk for metastatic disease.
June 2016: Cancer Discovery
Inès Beumer, Anke Witteveen, Leonie Delahaye, Diederik Wehkamp, Mireille Snel, Christa Dreezen, John Zheng, Arno Floore, Guido Brink, Bob Chan, Sabine Linn, Rene Bernards, Laura van 't Veer, Annuska Glas
MammaPrint is an FDA-cleared microarray-based test that uses expression levels of the 70 MammaPrint genes to assess distant recurrence risk in early-stage breast cancer. The prospective RASTER study proved that MammaPrint Low Risk patients can safely forgo chemotherapy, which is further subject of the prospective randomized MINDACT trial. While MammaPrint diagnostic results are obtained from mini-arrays, clinical trials may be performed on whole-genome arrays. Here we demonstrate the equivalence and reproducibility of the MammaPrint test...
April 2016: Breast Cancer Research and Treatment
Nola M Hylton, Constantine A Gatsonis, Mark A Rosen, Constance D Lehman, David C Newitt, Savannah C Partridge, Wanda K Bernreuter, Etta D Pisano, Elizabeth A Morris, Paul T Weatherall, Sandra M Polin, Gillian M Newstead, Helga S Marques, Laura J Esserman, Mitchell D Schnall
PURPOSE: To evaluate volumetric magnetic resonance (MR) imaging for predicting recurrence-free survival (RFS) after neoadjuvant chemotherapy (NACT) of breast cancer and to consider its predictive performance relative to pathologic complete response (PCR). MATERIALS AND METHODS: This HIPAA-compliant prospective multicenter study was approved by institutional review boards with written informed consent. Women with breast tumors 3 cm or larger scheduled for NACT underwent dynamic contrast-enhanced MR imaging before treatment (examination 1), after one cycle (examination 2), midtherapy (examination 3), and before surgery (examination 4)...
April 2016: Radiology
Mark Jesus M Magbanua, Denise M Wolf, Christina Yau, Sarah E Davis, Julia Crothers, Alfred Au, Christopher M Haqq, Chad Livasy, Hope S Rugo, Laura Esserman, John W Park, Laura J van 't Veer
INTRODUCTION: The molecular biology involving neoadjuvant chemotherapy (NAC) response is poorly understood. To elucidate the impact of NAC on the breast cancer transcriptome and its association with clinical outcome, we analyzed gene expression data derived from serial tumor samples of patients with breast cancer who received NAC in the I-SPY 1 TRIAL. METHODS: Expression data were collected before treatment (T1), 24-96 hours after initiation of chemotherapy (T2) and at surgery (TS)...
May 29, 2015: Breast Cancer Research: BCR
Angela DeMichele, Douglas Yee, Donald A Berry, Kathy S Albain, Christopher C Benz, Judy Boughey, Meredith Buxton, Stephen K Chia, Amy J Chien, Stephen Y Chui, Amy Clark, Kirsten Edmiston, Anthony D Elias, Andres Forero-Torres, Tufia C Haddad, Barbara Haley, Paul Haluska, Nola M Hylton, Claudine Isaacs, Henry Kaplan, Larissa Korde, Brian Leyland-Jones, Minetta C Liu, Michelle Melisko, Susan E Minton, Stacy L Moulder, Rita Nanda, Olufunmilayo I Olopade, Melissa Paoloni, John W Park, Barbara A Parker, Jane Perlmutter, Emanuel F Petricoin, Hope Rugo, Fraser Symmans, Debasish Tripathy, Laura J van't Veer, Rebecca K Viscusi, Anne Wallace, Denise Wolf, Christina Yau, Laura J Esserman
The many improvements in breast cancer therapy in recent years have so lowered rates of recurrence that it is now difficult or impossible to conduct adequately powered adjuvant clinical trials. Given the many new drugs and potential synergistic combinations, the neoadjuvant approach has been used to test benefit of drug combinations in clinical trials of primary breast cancer. A recent FDA-led meta-analysis showed that pathologic complete response (pCR) predicts disease-free survival (DFS) within patients who have specific breast cancer subtypes...
July 1, 2015: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Frédéric Dutheil, Patrick Chambres, Cédric Hufnagel, Catherine Auxiette, Pierre Chausse, Raja Ghozi, Guillaume Paugam, Gil Boudet, Nadia Khalfa, Geraldine Naughton, Alain Chamoux, Martial Mermillod, Pierre Raphael Bertrand
INTRODUCTION: Individuals with autism spectrum disorder (ASD) have difficulties in communication and social interaction resulting from atypical perceptual and cognitive information processing, leading to an accumulation of anxiety. Extreme overloading experienced internally may not be externally visible. Identifying stressful situations at an early stage may avoid socially problematic behaviour from occurring, such as self-injurious behaviour. Activation of the autonomous nervous system (ANS) is involved in the response to anxiety, which can be measured through heart rate variability and skin conductance with the use of portable devices, non-intrusively and pain-free...
February 20, 2015: BMJ Open
(no author information available yet)
No abstract text is available yet for this article.
June 2014: Cancer Discovery
Elizabeth L Cureton, Christina Yau, Michael D Alvarado, Helen Krontiras, David W Ollila, Cheryl A Ewing, Sindy Monnier, Laura J Esserman
BACKGROUND: Increasingly, women with stage 2 and 3 breast cancers receive neoadjuvant therapy, after which many are eligible for breast-conserving surgery (BCS). The question often arises as to whether BCS, if achievable, provides adequate local control. We report the results of local recurrence (LR) from the I-SPY 1 Trial in the setting of maximal multidisciplinary treatment where approximately 50 % of patients were treated with BCS. METHODS: We analyzed data from the I-SPY 1 Trial...
September 2014: Annals of Surgical Oncology
Amy S Clark, Jinbo Chen, Shiv Kapoor, Claire Friedman, Carolyn Mies, Laura Esserman, Angela DeMichele
Laboratory studies suggest that vitamin D (vitD) enhances chemotherapy-induced cell death. The objective of this study was to determine whether pretreatment vitD levels were associated with response to neoadjuvant chemotherapy (NACT) in women with breast cancer. Study patients (n = 82) were enrolled on the I-SPY TRIAL, had HER2-negative tumors, and available pretreatment serum. VitD levels were measured via DiaSorin radioimmunoassay. The primary outcome was pathologic residual cancer burden (RCB; dichotomized 0/1 vs...
June 2014: Cancer Medicine
(no author information available yet)
In results from one part of the I-SPY 2 trial announced at the 2013 San Antonio Breast Cancer Symposium, neoadjuvant veliparib plus carboplatin improved outcomes for women with triple-negative breast cancer.
February 2014: Cancer Discovery
Michael J Campbell, Denise Wolf, Rita A Mukhtar, Vickram Tandon, Christina Yau, Alfred Au, Frederick Baehner, Laura van't Veer, Donald Berry, Laura J Esserman
Tumor associated macrophages (TAMs) are recruited from the circulation to the tumor site, and can undergo a spectrum of phenotypic changes, with two contrasting activation states described in the literature: the M1 and M2 phenotypes. We previously identified a population of TAMs that express proliferating cell nuclear antigen (PCNA) and are associated with high grade, hormone receptor negative breast cancers and poor outcomes. In the present exploratory study we again found that high PCNA(+) TAM counts in pre-treatment tumor biopsies (102 invasive breast cancer cases from the I-SPY 1 Trial, a prospective neoadjuvant trial with serial core biopsies and gene array data) were associated with high grade, hormone receptor negativity, and decreased recurrence free survival...
2013: PloS One
Brian M Alexander, Patrick Y Wen, Lorenzo Trippa, David A Reardon, Wai-Kwan Alfred Yung, Giovanni Parmigiani, Donald A Berry
The traditional clinical trials infrastructure may not be ideally suited to evaluate the numerous therapeutic hypotheses that result from the increasing number of available targeted agents combined with the various methodologies to molecularly subclassify patients with glioblastoma. Additionally, results from smaller screening studies are rarely translated to successful larger confirmatory studies, potentially related to a lack of efficient control arms or the use of unvalidated surrogate endpoints. Streamlining clinical trials and providing a flexible infrastructure for biomarker development is clearly needed for patients with glioblastoma...
August 2013: Neuro-oncology
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