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I spy trial

John R Scheel, Eunhee Kim, Savannah C Partridge, Constance D Lehman, Mark A Rosen, Wanda K Bernreuter, Etta D Pisano, Helga S Marques, Elizabeth A Morris, Paul T Weatherall, Sandra M Polin, Gillian M Newstead, Laura J Esserman, Mitchell D Schnall, Nola M Hylton
OBJECTIVE: The objective of our study was to determine the accuracy of preoperative measurements for detecting pathologic complete response (CR) and assessing residual disease after neoadjuvant chemotherapy (NACT) in patients with locally advanced breast cancer. SUBJECTS AND METHODS: The American College of Radiology Imaging Network 6657 Trial prospectively enrolled women with ≥ 3 cm invasive breast cancer receiving NACT. Preoperative measurements of residual disease included longest diameter by mammography, MRI, and clinical examination and functional volume on MRI...
April 30, 2018: AJR. American Journal of Roentgenology
Adam Olshen, Denise Wolf, Ella F Jones, David Newitt, Laura J van ‘t Veer, Christina Yau, Laura Esserman, Julia D Wulfkuhle, Rosa I Gallagher, Lisa Singer, Emanuel F Petricoin, Nola Hylton, Catherine C Park
Although the role of cancer-activated stroma in malignant progression has been well investigated, the influence of an activated stroma in therapy response is not well understood. Using retrospective pilot cohorts, we previously observed that MRI detected stromal contrast enhancement was associated with proximity to the tumor and was predictive for relapse-free survival in patients with breast cancer receiving neoadjuvant chemotherapy. Here, to evaluate the association of stromal contrast enhancement to therapy, we applied an advanced tissue mapping technique to evaluate stromal enhancement patterns within 71 patients enrolled in the I-SPY 1 neoadjuvant breast cancer trial...
January 2018: Journal of Medical Imaging
Damian Manzone, Tristan Loria, Luc Tremblay
The authors investigated how visual information from the nondominant and dominant eyes are utilized to control ongoing dominant hand movements. Across 2 experiments, participants performed upper-limb pointing movements to a stationary target or an imperceptibly shifted target under monocular-dominant, monocular-nondominant, and binocular viewing conditions. Under monocular-dominant viewing conditions, participants exhibited better endpoint precision and accuracy. On target jump trials, participants spent more time after peak limb velocity and significantly altered their trajectories toward the new target location only when visual information from the dominant eye was available...
September 26, 2017: Journal of Motor Behavior
Denise M Wolf, Christina Yau, Ashish Sanil, Annuska Glas, Emanuel Petricoin, Julia Wulfkuhle, Tesa M Severson, Sabine Linn, Lamorna Brown-Swigart, Gillian Hirst, Meredith Buxton, Angela DeMichele, Nola Hylton, Fraser Symmans, Doug Yee, Melissa Paoloni, Laura Esserman, Don Berry, Hope Rugo, Olufunmilayo Olopade, Laura van 't Veer
Veliparib combined with carboplatin (VC) was an experimental regimen evaluated in the biomarker-rich neoadjuvant I-SPY 2 trial for breast cancer. VC showed improved efficacy in the triple negative signature. However, not all triple negative patients achieved pathologic complete response and some HR+HER2- patients responded. Pre-specified analysis of five DNA repair deficiency biomarkers (BRCA1/2 germline mutation; PARPi-7, BRCA1 ness, and CIN70 expression signatures; and PARP1 protein) was performed on 116 HER2- patients (VC: 72 and concurrent controls: 44)...
2017: NPJ Breast Cancer
Sonya Das, Andrew W Lo
BACKGROUND: In this case study, we profile the I-SPY 2 TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And molecular anaLysis 2), a unique breast cancer clinical trial led by researchers at 20 leading cancer centers across the US, and examine its potential to serve as a model of drug development for other disease areas. This multicenter collaboration launched in 2010 to reengineer the drug development process to be more efficient and patient-centered...
November 2017: Contemporary Clinical Trials
Tesa M Severson, Denise M Wolf, Christina Yau, Justine Peeters, Diederik Wehkam, Philip C Schouten, Suet-Feung Chin, Ian J Majewski, Magali Michaut, Astrid Bosma, Bernard Pereira, Tycho Bismeijer, Lodewyk Wessels, Carlos Caldas, René Bernards, Iris M Simon, Annuska M Glas, Sabine Linn, Laura van 't Veer
BACKGROUND: Patients with BRCA1-like tumors correlate with improved response to DNA double-strand break-inducing therapy. A gene expression-based classifier was developed to distinguish between BRCA1-like and non-BRCA1-like tumors. We hypothesized that these tumors may also be more sensitive to PARP inhibitors than standard treatments. METHODS: A diagnostic gene expression signature (BRCA1ness) was developed using a centroid model with 128 triple-negative breast cancer samples from the EU FP7 RATHER project...
August 25, 2017: Breast Cancer Research: BCR
Mindi F Messmer, Erin E Wilhelm, Ira Shoulson
No abstract text is available yet for this article.
September 1, 2017: JAMA Neurology
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...
August 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...
September 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
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