Background Surgical planning and local-regional treatment of breast cancer relies on accurate assessment of disease extent including the primary tumor size and the presence/absence of multiple tumor foci. As a staging modality for breast cancer, MRI has shown high sensitivity for detection of additional foci of diseases within the index breast. However, the impact of preoperative breast MRI on reducing re-excision rates and improving local control is less clear. Data from the COMICE trial in the UK suggested that routine use of pre-operative breast MRI did not alter rates of re-excision; however issues have been raised about the lack of quality standards for the MR imaging that may have resulted in the negative results of this trial. Retrospective data suggest that local recurrence is not impacted by use of breast MRI. In concert with data showing no improvement in clinical outcomes of breast cancer patients, concerns have been raised that routine use of preoperative breast MRI is associated with increased rates of mastectomy and delays to surgery. Therefore, the application of MRI for preoperative surgical staging remains controversial. In order to address this ongoing controversy, a joint effort has been launched by ACOSOG and ACRIN for a prospective clinical trial focused on evaluating the impact of preoperative breast MRI on clinically relevant patient outcomes. An important part of this collaboration is implementation of standards of how MRI findings should be clinically managed and used to direct localization methods and surgical planning, thereby creating guidelines for subsequent patient intervention. Trial design/eligibility criteria: A prospective multicenter trial will include women eligible for BCT by standard criteria and randomized between current standard of care, clinical examination and mammography (+/− ultrasound) and the same plus preoperative breast MRI. The study will focus on women at the highest risk of local recurrence: ER/PR/HER-2 negative (triple negative) and HER-2 amplified breast cancers. Specific aims: To compare the rates of local recurrence following breast conserving therapy in a cohort randomized to preoperative staging with mammography or mammography plus breast MRI. Additionally, a comparison of rates of re-operation, time to local recurrence, survival outcomes, contralateral breast cancer rates, rates of multicentric disease and other secondary aims will be performed. Costs and quality of life measures will also be investigated. Statistical methods: A stratified logrank test and Cox partial likelihood score test will be used to assess whether the distribution of LR times differs with respect to diagnostic work-up approach having adjusted for tumor stage. Cox modeling with the Cox partial likelihood score test will be used to examine the strength of association between these time to event distributions and such additional potential prognostic factors as menopausal status, chemotherapy, radiation therapy, ER, PR, number of positive lymph nodes, HER-2/neu expression, Nottingham grade, and Ki-67 expression. Target Accrual: 556 patients Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr OT2-05-06.
Background Functional MRI techniques may be utilized for characterizing breast tumors and measuring response to neoadjuvant chemotherapy (NAC). Dynamic contrast enhanced (DCE) MRI is the most common functional breast MRI technique. Fitting DCE MRI data to an appropriate pharmacokinetic model allows noninvasive, in vivo measurement of physiological parameters related to tissue perfusion, microvascular permeability, and extracellular/extravascular volume fraction. Diffusion weighted imaging (DWI) MRI is an alternative technique that measures the mobility of water molecules in vivo and is sensitive to tissue characteristics such as cell density, membrane permeability, and microstructure. DWI provides complementary information to DCE MRI about tumor biology and has shown promise for early prediction of response. The master ISPY2 multi-center study is a process targeting the rapid, focused clinical development of paired oncologic therapies and biomarkers. Its framework is an adaptive phase II clinical trial design in the neoadjuvant setting for women with locally advanced breast cancer. As a sub-study, ACRIN 6698 will combine both DCE and DWI MRI data to generate novel imaging biomarkers that correlate with treatment response. The two studies will provide a rich data set that can be used to elucidate molecular pathways and tumor responses to novel investigational drugs with standard chemotherapy. Trial design: ACRIN 6698 will perform advanced DCE and DWI MR imaging as part of the I-SPY TRIAL. The ISPY 2 adaptive therapy design will use different tumor biomarker assays to identify patients with high risk of recurrence. Patients will receive NAC doublet chemotherapy and trastuzumab (if Her2+). Patients will be randomized and stratified into different arms receiving investigational agents of different drug classes. ACRIN 6698 patients will receive four advanced MRI exams (both DCE and DWI) at baseline, early therapy, mid therapy and prior to surgery. Specific aims: The primary aim will determine if the % change in tumor apparent diffusion coefficient (ADC) measured on DWI from baseline to early treatment timepoint is predictive of pathologic complete response (pCR). The secondary aim will determine if the combined measurement of percentage change in tumor ADC on DWI, and percentage change in tumor volume and peak signal enhancement ratio (SER) on DCE MRI is predictive of pCR. Statistical methods: Receiver operating characteristic (ROC) curve and corresponding area under the ROC curves (AUC) for the individual marker, % change in tumor ADC, and % change in tumor volume and peak SER, will be estimated. Linear score of the 3 markers will be derived by fitting the multivariate logistic regression model, where the outcome is a binary variable for pCR and the predictors are the 3 measurements. The ROC curve for the derived linear score will be constructed and its AUC value will be estimated. Target accrual: ACRIN 6698 is open to ISPY 2 sites. The target accrual is 200 of ISPY 2's planned enrollment of 800 participants. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr OT2-03-06.
Background Imaging technologies monitoring and predicting breast cancer response to neoadjuvant chemotherapy (NAC) are of increasing interest. The utility of conventional imaging approaches varies and identifies the need for alternate functional imaging strategies. The use of model-based photon migration methods to quantitatively separate light absorption from scattering in multiply-scattering tissues is a type of near-infrared spectroscopy (NIRS) broadly referred to as diffuse optical spectroscopy (DOS) [Bevilacqua, et al. Applied Optics, 2000; Jakubowski, et al., J of Applied Optics, 2009]. DOSI is a promising experimental technology that allows patients undergoing NAC to be followed with a “no significant risk” device meeting Food and Drug Administration criteria for exempt status. The current design is a mobile device which offers increased accessibility and is relatively simple to perform and interpret, as compared to mammography, magnetic resonance imaging, and positron emission tomography. Due to its size and portability, DOSI is a low barrier-to-access technology, creating new opportunities for patients to receive personalized treatment and for physicians to gain new insight into response mechanisms. The long-term goal is to provide oncologists with a relatively simple, risk-free bedside tool that can be used to help inform medical decisions on chemotherapy regimen, duration, and timing of surgery, thereby maximizing therapeutic response and minimizing unnecessary toxicity. Trial design: In this phase I/II prospective single arm study, patients will receive SOC NAC at five (5) NCI Network for Translational Research in Optical Imaging (NTROI) clinical sites with identical DOSI instruments and procedures. Patients will receive four DOSI exams: at baseline before chemotherapy, at early therapy 5–10 days after NAC initiation, at mid therapy, and at post therapy prior to surgery. The protocol will evaluate a harmonized DOSI technology platform that has been standardized for NAC monitoring. Eligibility: Women who have been diagnosed with breast cancer, have had confirmation by pre-treatment biopsy, and are scheduled to receive NAC followed by surgery are eligible for this trial. Specific aims: The primary aim of this clinical trial is to determine whether the baseline to mid-therapy changes in the DOSI measurement of the quantitative tumor tissue optical index can predict final pathologic complete response in patients with breast cancer undergoing NAC. The secondary aims investigate the correlation between additional DOSI quantitative measurements of tumor biochemical composition obtained at other timepoints, the full range of pathologic response (i.e. complete, partial, and non-response), and any corresponding imaging measurements. Statistical methods: Logistic regression models will be used to study the relationships between pathological complete response and percent change in tissue optical index tumor to normal ratio at different imaging time points. Study size: A total of sixty (60) patients will be enrolled in this imaging study. Currently, one patient has accrued. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr OT2-05-02.
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