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Key Trials Showcase the Utility of Neratinib in HER2+ Breast Cancer

In Clinical Trials by Barbara Jacoby

By: Caroline Seymour From: onclive.com Given the number of prophylactic interventions that are now available, counseling patients with early-stage HER2-positive breast cancer on the benefit of extended adjuvant therapy with neratinib (Nerlynx) or considering its use in those with central nervous system metastases could be beneficial, said Michel Velez, MD. “We know that neratinib has value in the extended adjuvant …

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Phase III Shows Benefit With Olaparib in Platinum-Sensitive BRCA+ Relapsed Ovarian Cancer

In Clinical Trials by Barbara Jacoby

By: Danielle Ternyila From: targetedonc.com According to topline findings from the multicenter, open-label, phase III SOLO3 trial, the overall objective response rate (ORR) was 72% with single-agent olaparib (Lynparza) versus 51% with chemotherapy in patients with platinum-sensitive, relapsed, germline BRCA-mutant ovarian cancer who were previously treated with at least 2 chemotherapy regimens. Further, in patients with only 2 prior lines …

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AstraZeneca’s immunotherapy drug scores key Phase III lung cancer win

In Clinical Trials by Barbara Jacoby

By: Alaric DeArment From: medcitynews.com The company said the Phase III CASPIAN study of Imfinzi in first-line, extensive-stage small-cell lung cancer was successful, but did not disclose further details. Roche’s Tecentriq is already approved for that indication, which accounts for two-thirds of SCLC cases. The days of Roche having an immunotherapy monopoly on the largest population of small-cell lung cancer …

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Polyphor announces enrollment of first patient in FORTRESS Phase III clinical trial for balixafortide in combination with eribulin in patients with metastatic breast cancer

In Clinical Trials by Barbara Jacoby

From: biospace.com Balixafortide is the most advanced and only CXCR4 antagonist in development in a pivotal Oncology global registration trial. Polyphor today announced the enrollment of the first patient in its FORTRESS clinical trial, the pivotal Phase III study evaluating balixafortide (POL6326) in combination with eribulin for the treatment of patients with HER2 negative, locally recurrent or metastatic breast cancer …

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Final Results of the KRISTINE Trial in HER2-Positive Breast Cance

In Clinical Trials by Barbara Jacoby

By: Dave Levitan From: cancernetwork.com Treatment for HER2-positive breast cancer with trastuzumab emtansine (T-DM1) plus pertuzumab yielded a higher risk of event-free survival (EFS) events compared with trastuzumab, pertuzumab, and chemotherapy, according to a phase III trial. There was a similar risk of invasive disease–free survival (IDFS) events, though, suggesting that chemotherapy may be unnecessary in some patients. The standard …

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Phase III NALA Trial Results in Higher PFS With Neratinib Combo for HER2+ Breast Cancer

In Clinical Trials by Barbara Jacoby

By: Jason M. Broderick From: targetedonc.com Combining Neratinib (Nerlynx) with capecitabine (Xeloda) showed a 24% reduction in the risk of disease progression or death compared with lapatinib (Tykerb) plus capecitabine in patients with HER2-positive metastatic breast cancer who had previously received 2 lines of HER2-targeted therapy, according to the results of the phase III NALA trial presented at the 2019 …

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CDK4/6 Inhibitors Firmly Established in HR+ Breast Cancer, OS Data Awaited

In Clinical Trials by Barbara Jacoby

By: Gina Columbus From: onclive.com The improvement in progression-free survival (PFS) that has been observed with CDK4/6 inhibitors in patients with metastatic hormone receptor (HR)–positive, HER2-negative breast cancer has led to changes in clinical practice. However, physicians are still awaiting further overall survival (OS) findings that will solidify the use of these agents, said Daphne B. Stewart, MD. Thus far, …

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Continuous chemotherapy improves outcomes and quality of life in advanced breast cancer

In Clinical Trials by Barbara Jacoby

Source: European Society for Medical Oncology From: eurekalert.org Continuous chemotherapy shows greater benefit in patients with advanced breast cancer by both improving survival and maintaining quality of life compared to intermittent scheduling, according to analyses of the Stop&Go study presented at the ESMO Breast Cancer Congress 2019, 2-4 May, Berlin, Germany. (1,2,3) The phase III study randomised 420 patients with …

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TRIO Enrolls First Patient Into PHASE III NATALEE Clinical Trial

In Clinical Trials by Barbara Jacoby

From: ptcommunity.com Translational Research In Oncology (TRIO), in collaboration with Novartis and under the direction of Dennis Slamon, MD, PhD, TRIO Chairman/Executive Director and Director of Clinical Translational Research at the University of California, Los Angeles Jonsson Comprehensive Cancer Center, announces enrollment of the first patient into its newest clinical trial, NATALEE (New Adjuvant TriAl with LEE). NATALEE is a …

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Athenex Announces Completion of Target Enrollment in the Oraxol Phase III Study

In Clinical Trials by Barbara Jacoby

By: GlobeNewswire From: nasdaq.com Athenex, Inc. (NASDAQ:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that target enrollment of 360 patients in the Oraxol Phase III clinical trial in metastatic breast cancer has been achieved on schedule. Athenex also reaffirms that top line data from …