Source: Translational Research In Oncology From: globenewswire.com Translational Research In Oncology (TRIO) today announced completion of enrollment for Novartis phase III clinical trial of ribociclib with endocrine therapy in the adjuvant treatment of HR-positive, HER2-negative early breast cancer (EBC). The trial, referred to as NATALEE (New Adjuvant TriAl with LEE), has enrolled 5101 patients globally. Rapid enrollment of this randomized, …
Sanofi’s, AstraZeneca’s and Radius’ oral SERDs could establish clinical worth in ER+ breast cancer by showing similar efficacy to Faslodex, experts say
By: Manasi Vaidyacl From: clinicaltrialsarena.com Oral SERDs by AstraZeneca, Sanofi and Radius Health can demonstrate clinical value by being comparable, rather than superior to, AstraZeneca’s Faslodex (fulvestrant) or generic aromatase inhibitors in oestrogen receptor positive (ER+) HER2-negative breast cancer, said experts. Oral SERDs by AstraZeneca, Sanofi and Radius Health can demonstrate clinical value by being comparable, rather than superior to, …
Polyphor’s balixafortide activity in advanced Her2-negative HR+ metastatic breast cancer fortifies Phase III chances
Source: GlobalData Healthcare From: pharmaceutical-technology.com by Manasi Vaidya in New York Polyphor’s positive balixafortide activity with Eisai’s Halaven (eribulin), along with the mechanistic potential, buttress Phase III prospects in Her2-negative HR+ metastatic breast cancer, said experts. Prior Phase I efficacy with balixafortide in combination with the chemotherapy Halaven in Her2-negative HR+ metastatic breast cancer patients is significant given the advanced …
Puma Biotechnology Presents Final Overall Survival Analysis from the Phase III ExteNET Trial at the 2020 SABCS
From: businesswire.com Results show continued efficacy of neratinib in patients with HER2-positive early stage breast cancer Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that efficacy results of neratinib in HER2-positive early stage breast cancer (eBC) from the Phase III ExteNET trial were presented at the 2020 Virtual San Antonio Breast Cancer Symposium (SABCS) that is currently taking place. …
FDA OKs Pembrolizumab in Advanced TNBC
By: Ian Ingram From: medpagetoday.com Checkpoint inhibitor nabs accelerated approval for PD-L1 expressors The FDA on Friday granted accelerated approval to pembrolizumab (Keytruda) for treating triple-negative breast cancer (TNBC) patients with metastatic or locally recurrent unresectable disease. TNBC becomes the astonishing 18th cancer indication for pembrolizumab, which was first approved in 2014 for advanced or unresectable melanoma. Pembrolizumab, a PD-1-directed …
New Research Study Supports Clinical Utility of Circulating Tumor Cell Count for Metastatic Breast Cancer
First randomized clinical trial demonstrating that CTC count may help personalize treatment choices Menarini Silicon Biosystems, the pioneer of liquid biopsy technology, today announced the publication of a research study providing support for the reliability of using circulating tumor cell (CTC) count to guide frontline therapy choice for patients with estrogen receptor-positive (ER+), HER2-negative (HER2) metastatic breast cancer. Published in …
New study sheds light on the best drug choices for some patients with advanced breast cancer
By: Institute of Cancer Research From: medicalxpress.com Patients with metastatic breast cancer carrying a particular mutation fare better on one form of hormone therapy than another and can be identified using a blood test, according to a new study. In a combined analysis of two major Phase III clinical trials, called SoFEA and EFECT, researchers were able to show that …
Trial finds benefit of immunotherapy-chemotherapy combination in early-stage triple-negative breast cancer
By: Dana Farber Cancer Institute From: medicalxpress.com Adding an immunotherapy agent to a three-drug chemotherapy regimen can improve the likelihood that early-stage triple-negative breast cancer will recede to undetectable levels, data from a clinical trial led by Dana-Farber/Brigham and Women’s Cancer Center suggests. The results of the trial, dubbed the IMpassion031 study, will be presented at the 2020 Congress of …
Puma Biotechnology Announces Publication of Overall Survival Results from Phase III ExteNET Trial Evaluating Neratinib in HER2-Positive, Hormone Receptor-Positive, Early Stage Breast Cancer
Source: Business Wire cliFrom: galvnews.com Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that efficacy results of neratinib in HER2-positive, hormone receptor-positive (HR+), early stage breast cancer (eBC) from the Phase III ExteNET trial were published in Clinical Breast Cancer. The manuscript appears in the October 5, 2020 online issue accessible at https://www.clinical-breast-cancer.com/article/S1526-8209(20)30258-5/fulltext. ExteNET was a multicenter, randomized, double-blind, …
Evive Biotech Sees Positive Results in Phase III Trial for CIN in Breast Cancer Patients
By: Krystle Vermes Source: BioSpace From: pharmalive.com Evive Biotech announced today that its Phase III study investigating F-627 to treat chemotherapy-induced neutropenia (CIN) in breast cancer patients has met its primary and secondary endpoints. F-627, also known as efbemalenograstim alpha, works by increasing the production of white blood cells. A low concentration of these cells is a common side effect …