I-SPY 2: Durvalumab plus Olaparib and Paclitaxel Triplet in High-Risk Breast Cancer “Graduates” to Phase 3 Study
In the I-SPY 2 clinical trial presented at the 2020 AACR annual meeting, the combination of durvalumab, olaparib, and paclitaxel, used as neoadjuvant therapy, improved the pathological complete responses of patients with high-risk HER2-negative stage II or III breast cancer, as well as in those with triple-negative breast cancer, compared with chemotherapy alone. These results signal that the triplet regimen has “graduated” for further study in a phase 3 clinical trial.
Adding CDK4/6 Inhibitor to Endocrine Therapy Improves Survival in Advanced Breast Cancer: New Standard of Care
Barcelona, Spain—Late-breaking data from 2 clinical trials presented at ESMO 2019 will likely change the treatment paradigm for pre- or postmenopausal women with hormone receptor (HR)-positive, HER2-negative breast cancer, regardless of menopausal status. The MONALEESA-3 study and the MONARCH-2 study showed an improved overall survival (OS) with the addition of the CDK4/6 inhibitor ribociclib (Kisqali) or abemaciclib (Verzenio) to endocrine therapy as first- or second-line therapy. The results were presented at the Presidential Session of the meeting.
Vincristine, Racial Disparities in Multiple Myeloma, and HER2 Metastatic Breast Cancer Are in the News
The past week in oncology-related news includes shortages of crucial pediatric cancer drug, results of a study of racial disparities in multiple myeloma, and new drug on the horizon for HER2 metastatic breast cancer.
Breast cancer research continues to extend survival across all subsets and settings of the disease, according to Sandra Cuellar, PharmD, BCOP, Director, PGY-2 Oncology and Clinical Oncology Pharmacist and Clinical Assistant Professor, University of Illinois Hospital and Health Sciences System, Chicago.
Talzenna (Talazoparib) New PARP Inhibitor Approved for the Treatment of HER2-Negative Advanced Breast Cancer with Germline BRCA Mutation
Two human genes, BRCA1 and BRCA2 (BRCA1/2), produce proteins that block the growth of cancer, such as breast or ovarian cancer. These proteins ensure the stability of each cell’s genetic material and help to repair damaged DNA. A mutation in either BRCA results in these proteins not functioning correctly. Specifically, DNA damage may not be repaired effectively, which can lead to cancer.
FDA Expands Indication for Kadcyla to Include the Adjuvant Treatment of HER2-Positive Early Breast Cancer
On May 3, 2019, the US Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (Kadcyla; Genentech) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Patients should be selected for treatment with this agent based on an FDA-approved companion diagnostic test (Ventana Medical System’s PATHWAY anti-HER-2/neu [4B5] Rabbit Monoclonal Primary Antibody assay or INFORM HER2 Dual ISH DNA Probe Cocktail assay).
On April 4, 2019, the US Food and Drug Administration (FDA) expanded the indication of palbociclib (Ibrance; Pfizer), a kinase inhibitor, in combination with specific endocrine therapies for men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This is the first hormonal-based therapy to be approved for men.
On March 27, 2019, the US Food and Drug Administration (FDA) issued an alert from its Office of Women’s Health announcing that, after more than 20 years of regulatory oversight, the agency is proposing amendments to the existing policy governing mammography services.
The large, randomized TAM-01 clinical trial demonstrated that 5 mg daily of tamoxifen for 3 years halved the risk for recurrence of breast intraepithelial neoplasia—atypical ductal hyperplasia, ductal carcinoma in situ (DCIS), and lobular carcinoma in situ—in women after surgery and reduced the risk for new contralateral breast cancer by 75% compared with placebo.
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Results 1 - 10 of 55
Results 1 - 10 of 55