FDA expands approved use of metastatic breast cancer treatment to include male patients

The FDA is extending the indication of Ibrance (palbociclib) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients.
Source: Food and Drug Administration - Category: American Health Source Type: news

Related Links:

We reported nodal and breast downstaging rates with NET, and compared axillary response rates following NET and neoadjuvant chemotherapy (NAC).MethodsConsecutive stage I –III breast cancer patients treated with NET and surgery from January 2009 to December 2019 were identified from a prospectively maintained database. Nodal pCR rates were compared between biopsy-proven node-positive patients treated with NET, and HR+/HER2- patients treated with NAC from November 2 013 to July 2019.Results127 cancers treated with NET and 338 with NAC were included. NET recipients were older, more likely to have lobular and lower-grade...
Source: Annals of Surgical Oncology - Category: Cancer & Oncology Source Type: research
In this study, we found that ZBTB1 is down-regulated in breast cancer and this down-regulation is associated with poor outcome of breast cancer patients. ZBTB1 suppresses breast cancer cell proliferation and tumor growth. The majority of breast cancers are estrogen receptor (ER) positive and selective estrogen receptor modulators such as tamoxifen have been widely used in the treatment of these patients. Unfortunately, many patients develop resistance to endocrine therapy. Tamoxifen-resistant cancer cells often exhibit higher HER2 expression and an increase of glycolysis. Our data revealed that ZBTB1 plays a critical role ...
Source: Journal of Biological Chemistry - Category: Chemistry Authors: Tags: Molecular Bases of Disease Source Type: research
TUESDAY, Oct. 6, 2020 -- For patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−), high-risk early breast cancer (EBC), the addition of abemaciclib to endocrine therapy (ET) increases the...
Source: Drugs.com - Pharma News - Category: Pharmaceuticals Source Type: news
TUESDAY, Oct. 6, 2020 -- For patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2 −), high-risk early breast cancer (EBC), the addition of abemaciclib to endocrine therapy (ET) increases the...
Source: Drugs.com - Pharma News - Category: Pharmaceuticals Source Type: news
rauch H Abstract PURPOSE: Patients with estrogen and/or progesterone receptor-positive, early breast cancer benefit from hormonal treatment, yet high global death burdens due to high prevalence and long-term recurrence risk call for biomarkers to guide additional treatment approaches. EXPERIMENTAL DESIGN: From a prospective, observational study of postmenopausal early breast cancer patients treated with tamoxifen or aromatase inhibitors gene expression analyses of 612 tumors was performed using the NanoString® Breast Cancer 360 panel to interrogate 23 breast cancer pathways. Candidate signatures associate...
Source: Clinical Cancer Research - Category: Cancer & Oncology Authors: Tags: Clin Cancer Res Source Type: research
Background: Hormone positive, HER-2 negative metastatic breast cancer (HR+/HER2- MBC) had always been challenging to treat. With the addition of Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors to the treatment armamentarium, these patients have not only shown improvement in progression free survival (PFS) and response rates (RR) but also overall survival (OS) has improved in both the lines compared with endocrine therapy (ET) alone. Since 2017, in India, the combination of CDK4/6 inhibitors with ET is standard therapy in HR+/HER2- MBC.
Source: European Journal of Cancer - Category: Cancer & Oncology Authors: Tags: POSTERS B: Advanced Disease Source Type: research
Background: In PALOMA-3, endocrine therapy (ET)-sensitive (ie, documented clinical benefit from prior ET or 2 y adjuvant ET before recurrence) pts with HR+/HER2 – ABC and disease progression on prior ET derived overall survival (OS) benefit from palbociclib (PAL) + fulvestrant (FUL) vs placebo (PBO)+FUL. In pts who received prior chemotherapy (CT) for ABC, median (m)OS was similar between treatment arms, suggesting that prior CT impacts the benefit of PAL +FUL. This post hoc analysis reports OS and progression-free survival (PFS) in the ITT and ET-sensitive populations from PALOMA-3 with/without prior CT for ABC and ...
Source: European Journal of Cancer - Category: Cancer & Oncology Authors: Tags: PROFFERED PAPER SESSION: Proffered Paper Session Source Type: research
Background: Early breast cancer (EBC) is not a single disease but consists of several clinically relevant molecular subtypes. Within hormone receptor positive (HR+), HER2 negative (HER2 −) disease, different luminal subtypes (A vs. B) impact on outcome and response to endocrine therapy. Gene expression signatures predicting risk of recurrence are already part of clinical management. Gene profiles correlated with important tumor pathways such as metastasis and progression, immune response or proliferation also correlate with clinical outcome and therapy response.
Source: European Journal of Cancer - Category: Cancer & Oncology Authors: Tags: POSTERS A: Basic Science and Translational Research Source Type: research
Background: The cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) represented the standard I-II lines of hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2 −) metastatic breast cancer (MBC). Data regarding toxicity safety profiles when combining CDK4/6i with palliative radiotherapy (RT) are still lacking. RT use with palliative and ablative intents is currently increasing due to promising results in the oligometastatic setting. We aim to investigate acute adverse events (AEs) before, at the start, two, and six weeks after RT completion.
Source: European Journal of Cancer - Category: Cancer & Oncology Authors: Tags: POSTERS A: Advanced Disease Source Type: research
Background: Cyclin-dependent kinases (CDK) 4/6 inhibitors have recently reshaped the therapeutic scenario for hormone receptor (HR)-positive/HER2-negative metastatic breast cancer (MBC). Elevated serum lactate dehydrogenase (LDH) levels correlate with poor prognosis in various malignancies, including MBC. However, no data are available on LDH prognostic value in patients treated with CDK4/6 inhibitors. Henceforth, we explored whether plasmatic LDH could represent a prognostic biomarker in patients treated with endocrine therapy (ET) and the CDK4/6 inhibitor palbociclib.
Source: European Journal of Cancer - Category: Cancer & Oncology Authors: Tags: POSTERS A: Advanced Disease Source Type: research
More News: American Health | Breast Cancer | Cancer | Cancer & Oncology | Endocrine Therapy | Food and Drug Administration (FDA) | HER2 | Hormones