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Presentation from the 2017 San Antonio Breast Cancer Symposium by Douglas Yee, MD Masonic Cancer Center, University of Minnesota

Pathological complete response (pCR) is a strong predictor of event-free survival (EFS) and distant recurrence- free survival (DRFS) in the setting of a multiple agent platform trial that includes:

  • Standards for eligibility: high risk for early recurrence (MP low risk, HR+Her2- excluded), exclusion of metastatic disease
  • All chemotherapy given before pCR determination
  • Standards for pathology assessment and multidisciplinary identification (surgeons, radiologists, pathologists)
  • Long term follow-up of patients over time (correlation of early, intermediate, and late endpoints)

pCR is equally predictive across all tumor subsets, and as an endpoint enables rapid evaluation of novel therapy

New Data Analyses Presented at San Antonio Breast Cancer Symposium Spotlight Predictive Response to Pembrolizumab and MK-2206, and Demonstrate Improved Predictive Performance of Breast MRI

SAN FRANCISCO, C.A., December 7, 2017 – Investigators with the I-SPY TRIALs for Breast Cancer, sponsored and managed by Quantum Leap Healthcare Collaborative, presented analyses today at the 2017 San Antonio Breast Cancer Symposium (SABCS) detailing four promising new or improved pathways for predicting response to therapeutic agents in the neoadjuvant setting. Three of the analyses provide new insights into biomarkers associated with the triple negative breast cancer subset, and a fourth concludes that combining measurement of functional tumor vo...

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Data Presented at San Antonio Breast Cancer Symposium Show Significant and Clinically Impactful Relationship Between pCR and Event-Free Survival in High-Risk Breast Cancer

SAN FRANCISCO, C.A., December 7, 2017 – Quantum Leap Healthcare Collaborative, sponsor and manager of the I-SPY TRIALs for Breast Cancer, today announced results from the long-term I-SPY 2 efficacy investigation, which has demonstrated achievement of pathological complete response (pCR) to be a very strong surrogate endpoint for improved event-free survival (EFS) and distant disease-free survival (DDFS) in high-risk breast cancer. Data was presented in an oral presentation at the annual meeting of the San Antonio Breast Cancer Symposium by Douglas Yee, M.D., Unive...

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SAN CARLOS, Calif., Aug. 21, 2017 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a leader in non-invasive genetic testing, today announced the launch of SignateraTM, a circulating tumor DNA (ctDNA) technology that analyzes and tracks mutations specific to an individual's tumor, for research use only (RUO) by oncology researchers and biopharmaceutical companies.

Already in clinical validation with multiple world-leading cancer institutes, SignateraTM offers a novel personalized approach to cancer detection in plasma. The technology analyzes whole-exome sequencing data from a patient's tumor sample in order to custom design individual-specific assays, targeting 16 or more mutations known to be present in the tumor tissue ("tumor signatures")....

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Data to Be Presented at 2017 ASCO Annual Meeting Include Findings in Patients with Locally Advanced Triple-Negative (TNBC) and Hormone Receptor-Positive/HER2-Negative (HR+/HER2-) Breast Cancers

KENILWORTH, N.J. & SAN FRANCISCO, June 5, 2017 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, and QuantumLeap Healthcare Collaborative, today announced results from the Phase 2 I-SPY 2 TRIAL investigating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with standard therapy [paclitaxel followed by doxorubicin and cyclophosphamide (AC)] as a neoadjuvant (pre-operative) treatment for patients with locally advanced triple-negative breast cancer (TNBC) or hormone receptor-positive/HER2-nega...

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Triple Negative Breast Cancer Day — recognized annually on March 3 — is a global awareness and grassroots fundraising campaign initiated by the Triple Negative Breast Cancer Foundation.

In conjunction with Triple Negative Breast Cancer Day, HemOnc Today presents five updates in the treatment of triple-negative breast cancer, as well as on disparities associated with its incidence, that may impact your practice.

The combination of mifepristone and eribulin appeared active in women with recurrent, glucocorticoid receptor–positive triple-negative breast cancer, Sharon Wilks, MD, FACP, told HemOnc Today at the San Antonio Breast Cancer Symposium. Watch here.

Mitochondrial DNA testing may identify genetic ancestry that is di...

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The triple-negative breast cancer (TNBC) pipeline is transforming, experts say, with the potential additions of immunotherapy and PARP inhibitors. These agents are being explored both as monotherapy and in combination regimens with standard chemotherapy options.

At the 2016 San Antonio Breast Cancer Symposium, treatment with pembrolizumab (Keytruda) continued to show a consistent durable benefit with an additional year of follow-up for heavily pretreated patients with recurrent PD-L1–positive TNBC, according to findings from the phase Ib KEYNOTE-012 trial.

At a median follow-up of 10.7 months, the median progression-free survival (PFS) was 1.9 months (95% CI, 1.6-5.5), and the 12-month PFS rate was 17.8%. The median overall surviva...

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Over the last decade, the cost of sequencing an individual’s genome has plunged from about $10 million to about $1,000. Simultaneously, in an effort to shore up aging blockbuster and me-too models of drug development, the pharmaceutical industry has rebalanced its pipeline to focus on unmet medical needs. The era of genomic (aka precision or “personalized”) medicine has truly arrived.

Sequencing the genome has given rise to other “omic” technologies, such as proteomics (the large-scale study of proteins), pharmacogenomics (how genes affect a person’s response to drugs), and metabolomics (the metabolic responses to pathophysiological stimuli or genetic variation), which also have become more affordable....

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2016 will go down as a year that taught us to question our assumptions. The election of Donald Trump, an outcome almost no one predicted, left many with a sense of uncertainty about what 2017 will bring in the biomedical and health-care space. To bring clarity to these unsure times, FasterCures has compiled a list of issues critical to the future of medical innovation that we’ll be tracking over the coming year. While some issues will be closely linked with the people and policies of the new presidential administration, we think all will be important to continuing the progress toward faster cures and treatments.

1. FDA: What is the roadmap going forward?2017 could be an exceptionally important year at the Food and Drug Administrati...

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The 2016 San Antonio Breast Cancer Symposium may be wrapping up, but the coverage is not over. Here are new research findings from day 5 to keep on your radar.

Liquid biopsy might not be a reliable surrogate for tumor biopsy in metastatic breast cancer

Liquid biopsy is a minimally invasive technique that holds immense potential for making treatment decisions in oncology, but the results of abstract P6-07-03 suggest a note of caution. The small study reports that circulating tumor DNA (ctDNA) in plasma, or a liquid biopsy, does not accurately reflect tumor DNA for metastatic breast cancer patients.

The researchers obtained blood samples and tumor samples from 7 patients with multiple advanced breast cancer lesions. Then they extracted and...

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