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Tyme Technologies Begins Cancer Metabolism-Based Therapy Trial in Breast Cancer Patients

In Clinical Studies News by Barbara Jacoby

By: Staff Reporter From: precisiononcologynews.com Tyme Technologies said on Monday it has dosed the first patient in its Phase II OASIS trial of SM-88 in previously treated metastatic hormone receptor (HR)-positive HER2-negative breast cancer patients. The investigator-initiated study at Georgetown University will initially enroll 30 patients with metastatic HR-positive HER2-negative breast cancer who have previously received at least two lines …

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Carrick Therapeutics, Roche Partner for Breast Cancer Combination Trial

In Clinical Studies News by Barbara Jacoby

By: Staff Writer From: precisiononcologynews.com Carrick Therapeutics and Roche announced a clinical collaboration on Monday to study Carrick’s samuraciclib and Roche’s giredestrant in CDK4/6 inhibitor resistant HR-positive, HER2-negative metastatic breast cancer. The two firms will begin a Phase Ib/II study evaluating the combination treatment using Roche’s Morpheus platform, which helps accelerate development of combinations for certain cancers. Samuraciclib is a …

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First-Line Palbociclib/Letrozole Shows Real-World Survival Benefit in HR+ Metastatic Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Kristi Rosa From: onclive.com Palbociclib in combination with endocrine therapy resulted in improved survival outcomes in a real-world population of patients with hormone receptor–positive, HER2-negative, metastatic breast cancer vs letrozole alone in the first-line setting. Palbociclib (Ibrance) in combination with endocrine therapy resulted in improved survival outcomes in a real-world population of patients with hormone receptor (HR)–positive, HER2-negative, metastatic …

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CONTESSA Trial Yields Positive Results for Patients with HER2-Positive Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Sara Karlovitch From: targetedonc.com In an interview with Targeted Oncology, Joyce O’Shaughnessy, MD, chair of Breast Cancer Research and chair of Breast Cancer Prevention Research at Baylor-Sammons Cancer Center of Texas Oncology, discussed the CONTESSA study of tesetaxel with a reduced dose of capecitabine versus capecitabine alone in patients with HR-positive, HER2-negative breast cancer. New data suggests that a …

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Dr. Kalinsky on Initial Results of the RxPONDER Trial in HR+/HER2- Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Kevin Kalinsky, MD, MS From: onclive.com Kevin Kalinsky, MD, MS, director of the Glenn Family Breast Center and Breast Medical Oncology at Winship Cancer Institute, and acting associate professor in the Department of Hematology and Medical Oncology at Emory University School of Medicine, discusses the initial results of the phase 3 RxPONDER trial in patients with hormone receptor (HR)–positive, …

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Natera Announces Prospective Randomized Clinical Trial to Evaluate Palbociclib in Early Stage Breast Cancer Patients Who Test Positive with Signatera™

In Clinical Studies News by Barbara Jacoby

Source: Natera, Inc. From: prnewswire.com Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA, today announced that its Signatera molecular residual disease (MRD) test will be used in the DARE study, a multi-center clinical trial of palbociclib (IBRANCE®), a CDK4/6 inhibitor developed by Pfizer for the treatment of HR-positive, HER2-negative advanced breast cancer when given in combination with …

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Palbociclib/Fulvestrant Prolongs PFS in Endocrine-Sensitive, HR+/HER2– Metastatic Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Lisa Astor From: targetedonc.com Patients with endocrine-sensitive hormone receptor–positive, HER2-negative metastatic breast cancer, treated with Frontline fulvestrant in combination with palbociclib experienced improvement in progression-free survival at 1 year compared with fulvestrant and placebo alone, achieving the primary end point of the phase 2 FLIPPER trial. Patients with endocrine-sensitive hormone receptor (HR)–positive, HER2-negative metastatic breast cancer, treated with Frontline …

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National Medical Products Administration (NMPA) Approves Chipscreen Bioscience’s Chidamide (Epidaza) for Breast Cancer Indication

In Clinical Studies News by Barbara Jacoby

Source: Shenzhen Chipscreen Biosciences Co., Ltd. From: prnewswire.com On November 29, 2019, Shenzhen Chipscreen Biosciences Co., Ltd. (Chipscreen Biosciences, Stock Symbol: 688321.SH) announced that the company’s lead innovative product Epidaza® (Chidamide), an oral subtype-selective histone deacetylase (HDAC) inhibitor, previously approved for recurrent and refractory peripheral T cell lymphoma in China, has received approval for marketing application in its second indication …

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Overall Survival Benefit in HR+ Advanced Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Gina Columbus From: targetedonc.com Results from the phase III MONARCH 2 trial showed that the addition of the CDK4/6 inhibitor abemaciclib (Verzenio) to fulvestrant (Faslodex) improved overall survival by 9.4 months compared with fulvestrant and placebo in patients with hormone receptor (HR)–positive, HER2-negative advanced breast cancer who progressed on prior endocrine therapy, according to data presented at the 2019 …