By: Nichole Tucker From: targetedonc.com Treatment with the novel HER2-hICD vaccine, AST-301, will be assessed in patients with HER2-low breast cancer in the phase 2 Cornerstone-001 trial (NCT05163223) following the FDA’s clearance of an investigational new drug application.1 According to an announcement by Aston Sci. Inc., the launch of FDA clearance and the launch of the study comes after the …
Trial of Odetiglucan Plus Pembrolizumab for Metastatic Breast Cancer Starts Dosing
By: Nichole Tucker From: targetedonc.com Treatment with the combination of odetiglucan or Imprime PGG and pembrolizumab had begun in patients with metastatic hormone-refractory breast cancer who are enrolled in a phase 2 clinical trial. The first patients with metastatic hormone-refractory breast cancer in a phase 2 study have been dosed with the combination of odetiglucan (Imprime PGG) and pembrolizumab (Keytruda), …
IU School of Medicine launches new study to develop personalized therapies for triple-negative breast cancer patients
Source: IU School of Medicine From: medicine.iu.edu Indiana University School of Medicine researcher Bryan P. Schneider, MD, is leading a novel nationwide study to better understand how to treat patients with triple-negative breast cancer based on their own unique genetic data. PERSEVERE is a phase 2 clinical trial with the goal of studying personalized cancer treatment combinations when compared to …
Concurrent Chemoradiotherapy Better for Painful Bone Metastases in Breast Cancer
By: Colby Strong From: cancertherapyadvisor.com Concurrent chemoradiotherapy is tolerable and reduces pain better than radiotherapy alone for patients with breast cancer and painful bone metastases, according to research published in the Journal of Bone Oncology. The randomized, phase 2 study included 84 patients with breast cancer and painful bone metastases. The patients were randomly assigned to radiotherapy only (42 patients) …
Sermonix Pharmaceuticals Completes Enrollment of Phase 2 ELAINE 1 Randomized Clinical Trial Assessing Efficacy of Oral Lasofoxifene Versus Intramuscular Fulvestrant
Source: Sermonix Pharmaceuticals LLC From: globenewswire.com The study enrolled 100 patients who have ER+/HER2- breast cancer with an ESR1 mutation, with topline data expected in first half of 2022 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to treat ESR1-mutated metastatic breast and gynecological cancers, today announced that it has completed enrollment in its Phase 2 randomized …
CDK4/6 Inhibitors Continue to Build Traction in Early-Stage ER+/HER2- Breast Cancer
By: Caroline Seymour From: onclive.com Neoadjuvant and adjuvant treatment with CDK4/6 inhibitors has shown encouraging preliminary evidence in patients with estrogen receptor (ER)–positive, HER2-negative breast cancer, but confirmation of durable benefit is needed in the adjuvant setting before they are brought into routine clinical practice, explained Joyce A. O’Shaughnessy, MD, during a presentation at the 20th Annual International Congress on …
Talazoparib Is Active in gBRCA1/2 Mutation-Positive, HER2-Negative Early Breast Cancer
By: Walter Alexander From: cancertherapyadvisor.com Neoadjuvant talazoparib demonstrated activity and pathologic complete response (pCR) rates comparable to those observed with combination anthracycline and taxane-based chemotherapy regimens in a phase 2 trial of patients with germline BRCA1/2 (gBRCA1/2) mutation-positive, HER2-negative early breast cancer. The results were presented by Jennifer Keating Litton, MD, of The University of Texas MD Anderson Cancer Center …
CytoDyn’s Trial for Metastatic Triple-Negative Breast Cancer Demonstrates Safety with 350 mg, 525 mg and 700 mg Dosages; Officially Advances to Phase 2 from Phase 1b
Source: CytoDyn From: biospace.com CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today its clinical trial with leronlimab in combination with carboplatin for the treatment of metastatic triple-negative breast cancer (mTNBC) has advanced from Phase 1b to a Phase 2 trial. The positive …
TRIO Completes Enrolment for Phase 2 Giredestrant Early Breast Cancer Trial Ahead of Schedule
Source: Translational Research in Oncology From: finance.yahoo.com Translational Research in Oncology (TRIO), a global academic clinical research organization, announced today enrolment completion in coopERA Breast Cancer (WO42133/TRIO038), a Phase 2 randomized, multi-center, open-label clinical trial of giredestrant (GDC-9545) sponsored by F. Hoffmann-La Roche. This comes shortly after completion of the planned study interim analysis provided encouraging results and supported continuation …
FDA Approves Dose-Escalation Label Update for Neratinib in HER2+ Breast Cancer
By: Kristi Rosa From: onclive.com THe FDA has approved a labeling supplement to the US prescribing information for neratinib that includes the dose-escalated use of the agent in patients with HER2-positive breast cancer, as examined in the phase 2 CONTROL trial, and the new 133-count commercial Nerlynx SKU. The FDA has approved a labeling supplement to the US prescribing information …