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Neratinib Regimens Elicit CNS Responses in HER2+ Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Ellie Leick From: onclive.com A combined analysis of data from the NALA, NEfERT-T, and TBCRC 022 trials demonstrated potential with neratinib (Nerlynx) regimens for patients with HER2-positive breast cancer who have brain metastases, explained Nancy U. Lin, MD. In cohort 3a of the phase II TBCRC 022 trial, the combination of neratinib plus capecitabine (Xeloda) showed a composite CNS …

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New Compounds Kill Breast Cancer Cells and Block Tumor Growth

In In The News by Barbara Jacoby

From: scitechdaily.com Scientists have developed new drug compounds that thwart the pro-cancer activity of FOXM1, a transcription factor that regulates the activity of dozens of genes. The new compounds suppress tumor growth in human cells and in mouse models of several types of human breast cancer. The researchers report their findings in the journal NPJ Breast Cancer. FOXM1 is a …

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FDA approves new treatment, Enhertu, for patients with HER2-positive breast cancer

In Clinical Studies News by Barbara Jacoby

From: outbreaknewstoday.com The U.S. Food and Drug Administration granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. Enhertu is a human …

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Seattle Genetics Announces Submission of Tucatinib New Drug Application to the U.S. FDA for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer

In Clinical Studies News by Barbara Jacoby

Source: Business Wire From: apnews.com Seattle Genetics, Inc. (Nasdaq:SGEN) today announced it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tucatinib. This NDA requests FDA approval of tucatinib in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients …

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Margetuximab Update Elucidates Clinical Benefit in HER2+ Metastatic Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Jason M. Broderick From: onclive.com Margetuximab continued to show a clear progression-free survival (PFS) benefit and a trend toward an overall survival (OS) benefit versus trastuzumab (Herceptin) when either agent was combined with chemotherapy in patients with HER2-positive metastatic breast cancer who had received prior anti-HER2 therapies, according to updated findings from the phase III SOPHIA trial. Data from …

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Novel HER2-Targeted Agent May Improve Options in Recurrent Metastatic Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Rachel Narozniak, MA From: onclive.com In an effort to expand treatment options for patients with recurrent HER2-positive breast cancer, investigators are testing a novel antibody-drug conjugate (ADC): [fam-] trastuzumab deruxtecan (DS-8201a). The drug has achieved breakthrough therapy status. The phase III DESTINY-Breast02 study (NCT03523585) is recruiting 600 women with advanced disease who were previously treated with standard-of-care (SOC) ado-trastuzumab …

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Pivotal Data in HER2+ Breast Cancer Transform Paradigm

In Clinical Studies News by Barbara Jacoby

By: Ellie Leick From: onclive.com Research in HER2-positive breast cancer has led to a transition of traditional later-line therapies into earlier treatment settings to provide more options to patients with early-stage disease, explained Erika P. Hamilton, MD. “We have a lot of options for HER2-positive breast cancer now,” said Hamilton. “It’s very interesting that some of our options that we …

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Neratinib Plus Capecitabine Improves PFS in HER2-Positive Breast Cancer

In Clinical Studies News by Barbara Jacoby

From: oncnet.com Adam Brufsky, MD, PhD, University of Pittsburgh Comprehensive Breast Cancer Center, Pennsylvania, discusses results from the NALA study in which neratinib combined with capecitabine improved PFS in HER2-positive breast cancer.  Transcript: My name is Adam Brufsky. I’m a professor of medicine at the University of Pittsburgh. I’m co‑director of a comprehensive breast cancer center and associate chief of …

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Novel Approaches Push the Envelope in HER2+ Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Jessica Hergert From: onclive.com Developments in antibody-drug conjugates (ADCs), TKIs, and neoadjuvant interventions are improving outcomes for patients with early- and advanced-stage HER2-positive breast cancer, said Douglas K. Marks, MD, adding that investigational approaches could expand the treatment armamentarium even further. “For the treating oncologists, the options to offer patients who previously had a very poor prognosis are becoming …

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Dr. Bhave Discusses [Fam-] Trastuzumab Deruxtecan in HER2+ Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Manali Bhave, MD From: onclive.com Manali Bhave, MD, an assistant professor in the Department of Hematology and Medical Oncology at Winship Cancer Institute, Emory University School of Medicine, discusses the promise of [fam-] trastuzumab deruxtecan in HER2-positive breast cancer. [Fam-] trastuzumab deruxtecan is a promising antibody-drug conjugate under investigation. It has a novel payload, which is a topoisomerase inhibitor, …