Search Results
Your search for Fulvestrant for metastatic breast cancer matches 231 pages
Showing 151 - 200FDA Approvals in November 2017: Novel Drugs, New Indications
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) approved a number of novel drugs and new indications in November 2017. Several of them are listed here. Fulvestrant/Abemaciclib Combination in Breast Cancer ON NOVEMBER 15 , the FDA approved fulvestrant (Faslodex) in combination with abemaciclib...
Abemaciclib in Hormone Receptor–Positive, HER2-Negative Breast Cancer
On September 28, 2017, the cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor abemaciclib (Verzenio) was approved for use in combination with fulvestrant (Faslodex) for women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer with disease progression following...
FDA Approves Fulvestrant in Combination With Abemaciclib in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
Today, the U.S. Food and Drug Administration (FDA) approved a new indication for fulvestrant (Faslodex), expanding the drug's approved use to include combined therapy with abemaciclib (Verzenio), a cyclin-dependent kinase (CDK) 4/6 inhibitor, for the treatment of hormone receptor–positive,...
More Data From ESMO 2017
In GEICAM 2006-10, the addition of fulvestrant at 250 mg/d to anastrozole did not improve 5-year disease-free survival over anastrozole alone (91.0% vs 90.8%). “Immune induction” with chemotherapy or radiotherapy appeared to enhance response to nivolumab in women with metastatic triple-negative...
International Trials Reveal New Findings in the Management of Breast and Ovarian Cancers
The European Society for Medical Oncology (ESMO) 2017 Congress, held in Madrid, featured important news including at least seven practice-changing or potentially practice-changing trials, which are covered in recent issues of The ASCO Post. Here we present additional highlights of studies in breast ...
Expert Point of View: Nadia Harbeck, MD, PhD, and Sibylle Loibl, MD
NADIA HARBECK, MD, PhD, of the Breast Center at the University of Munich, Germany, said the findings of LORELEI are among a growing list of indications that “the future is bright for endocrine-based therapy.” Although the results were hypothesis-generating and not yet practice-changing, she...
Expert Point of View: Nicholas Turner, MD
NICHOLAS TURNER, MD, of The Royal Marsden and the Institute of Cancer Research in the UK, called the findings of MONARCH 3 “practice-changing.” The cyclin-dependent kinase 4/6 (CDK4/6) inhibitors have answered the need for agents that target the biology of estrogen receptor–positive breast cancer, ...
Abemaciclib Plus Endocrine Therapy Extends Progression-Free Survival in First-Line Therapy for Advanced Breast Cancer
THE VALUE OF cyclin-dependent kinase 4/6 (CDK4/6) inhibitors in advanced breast cancer became ever more certain with the announcement of interim data from MONARCH 3, which evaluated abemaciclib in combination with endocrine therapy as first-line therapy for hormone receptor–positive/HER2-negative...
Clinical Trials Actively Recruiting Patients With Breast Cancer
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on patients with breast cancer. These studies highlight neoadjuvant combination therapy, cell vaccines, novel imaging techniques, radiotherapy, and more. All of the studies are...
FDA Approves New CDK4/6 Inhibitor for Certain Advanced or Metastatic Breast Cancers
The U.S. Food and Drug Administration today approved abemaciclib (Verzenio) to treat adult patients who have hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after endocrine therapy. Abemaciclib is...
First-in-Human Study of Tamoxifen Metabolite Z-Endoxifen in Endocrine-Refractory Metastatic Breast Cancer
A first-in-human phase I study of the oral tamoxifen metabolite Z-endoxifen showed high drug exposure, acceptable toxicity, and antitumor activity in endocrine-refractory estrogen receptor–positive metastatic breast cancer. The findings were reported in the Journal of Clinical Oncology by...
FDA Approves Fulvestrant as Monotherapy for Expanded Use in Breast Cancer
On August 28, the U.S. Food and Drug Administration (FDA) approved fulvestrant (Faslodex) at 500 mg as monotherapy for expanded use in women with hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer who have gone through menopause...
A New Triumvirate in Estrogen Receptor–Positive Metastatic Breast Cancer
THE BODY OF EVIDENCE supporting the use of cell-cycle inhibitors in combination with endocrine therapy for estrogen receptor–positive metastatic breast cancer now has another agent in the spotlight. The phase III MONARCH 2 trial—reported at the 2017 ASCO Annual Meeting and by Sledge et al in the...
Fulvestrant Receives EC Approval as First-Line Therapy for Advanced Breast Cancer
On July 26, the European Commission (EC) approved fulvestrant (Falsodex) for the treatment of estrogen receptor–positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy. The EC approval is based on pivotal data from the...
Priority Review Granted for Abemaciclib in the Treatment of Advanced Breast Cancer
On July 10, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for abemaciclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, and gave the NDA a Priority Review designation. The NDA includes Eli Lilly and Company’s submission of abemaciclib for two indications: ...
Expert Point of View: Richard S. Finn, MD and Ingrid A. Mayer, MD
Richard S. Finn, MD, of the David Geffen School of Medicine at UCLA, Los Angeles, commented on MONARCH 2 and the field of cyclin-dependent kinase 4/6 (CDK4/6) inhibition in general in an interview with The ASCO Post. “MONARCH 2 is confirmatory for the role of CDK4/6 inhibition in estrogen...
Abemaciclib Plus Fulvestrant Delays Breast Cancer Progression in MONARCH 2
In the treatment of metastatic estrogen receptor–positive breast cancer, a highly significant 45% reduction in progression was achieved with abemaciclib, combined with fulvestrant (Faslodex), in the global phase III MONARCH 2 trial, reported at the 2017 ASCO Annual Meeting by George W. Sledge, MD,...
Adding Abemaciclib to Fulvestrant in Hormone Receptor–Positive, HER2-Negative Breast Cancer
In the phase III MONARCH 2 trial reported at the recent ASCO Annual Meeting and in the Journal of Clinical Oncology by Sledge et al, the addition of the selective cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor abemaciclib to fulvestrant (Faslodex) improved progression-free survival in hormone...
Palbociclib Combined With Aromatase Inhibitor in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
On March 31, 2017, palbociclib (Ibrance) was granted regular approval for treatment of hormone receptor–positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women.1,2 Palbociclib received...
Abemaciclib Active in Metastatic Breast Cancer
In the single-arm phase II MONARCH 1 trial, the investigational cyclin-dependent kinase 4/6 (CDK4/6) inhibitor abemaciclib achieved an objective response in about 20% of heavily pretreated patients with metastatic hormone receptor–positive, HER2-negative breast cancer and a disease control rate of...
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): 2017 Guidelines
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): 2017 Guidelines In 1996, the National Comprehensive Cancer Network® (NCCN®) published its first set of Clinical Practice Guidelines in Oncology®, covering 8 tumor types. Guidelines are now published for more than 60 tumor types and...
First-in-Human Experience With Abemaciclib
The investigational cyclin D–dependent kinase (CDK) 4/6 inhibitor abemaciclib was recently evaluated in several solid tumor types in a phase I multicenter trial.1 Given primarily as a single agent and with continuous dosing, abemaciclib showed encouraging early signals of clinical activity not only ...
Introduction: CDK4/6 Inhibitors: Moving Beyond the Breast Cancer Setting
The novel mechanism of action of drugs that inhibit the cyclin D–dependent kinases CDK4 and CDK6 has prompted effective new treatment strategies. Although the bulk of the data supporting the use of selective CDK4/6 inhibitors is currently in breast cancer, patients with other tumor types are...
Palbociclib Receives FDA Approval and Expanded Indication for First-Line Metastatic Breast Cancer
On March 31, the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for a first-in-class cyclin-dependent kinase (CDK) 4/6 inhibitor, palbociclib (Ibrance), based on the results from the confirmatory phase III trial PALOMA-2. The FDA action converts the...
Phase III Trial Shows Improved Progression-Free Survival With Fulvestrant vs Anastrozole in Advanced Breast Cancer
In the international phase III FALCON trial, reported in The Lancet, John F.R. Robertson, MD, of the University of Nottingham, United Kingdom, and colleagues found that progression-free survival was improved with intramuscular fulvestrant (Faslodex) vs oral anastrozole in endocrine therapy–naive...
FALCON Trial Informs the Evolving Role of Fulvestrant in Advanced Hormone Receptor–Positive Breast Cancer
Endocrine therapy for breast cancer has evolved over the years. Initial endocrine therapies consisted of ablative procedures (oophorectomy, adrenalectomy, and hypophysectomy). With the availability of pharmaceutical estrogens, progestins, and androgens, ablative procedure utilization begin to...
Results From MONALEESA-2: Are All CDK4/6 Inhibitors Equal?
Hormone receptor–positive breast cancer is the most common subtype of breast cancer, and while endocrine therapy has long been a mainstay of therapy for these patients, treatment resistance ultimately develops. Therefore, better therapeutic approaches are needed. There are some data to suggest...
Selected Abstracts From the 2016 San Antonio Breast Cancer Symposium
Each year, The ASCO Post asks Jame Abraham, MD, Director of the Breast Oncology Program at Taussig Cancer Institute and Co-Director of the Cleveland Clinic Comprehensive Breast Cancer Program, to give his picks for the most important research presented at the San Antonio Breast Cancer Symposium....
Oncology Drug Approvals in 2016
In 2016, the Office of Hematology and Oncology Products of the U.S. Food and Drug Administration (FDA) approved a number of new molecular entities, indications, and tests. The most notable were drug approvals in disease areas such as non–small cell lung cancer, myeloma, head and neck cancer, and...
Buparlisib Phase III Findings: Glass Half Empty or Half Full?
The pan-phosphoinositide 3-kinase (PI3K) inhibitor buparlisib combined with fulvestrant (Faslodex) prolonged progression-free survival compared with placebo and fulvestrant in postmenopausal women with hormone receptor–positive, HER2-negative advanced breast cancer previously treated with an...
Genomic Landscape of Metastatic Breast Cancer Differs From That of Primary Breast Cancer
Researchers working on whole-exome and transciptome sequencing of endocrine-resistant estrogen receptor–positive metastatic breast cancer have shown that the mutational landscape differs from that of estrogen receptor–positive primary breast cancer, and these differences have the potential to...
Expert Point of View: Virginia Kaklamani, MD
How can the results of this trial be applied to clinical practice? Press conference moderator, Virginia Kaklamani, MD, of the University of Texas Health Science Center in San Antonio, said: “The landscape has changed. Now we treat postmenopausal hormone receptor–positive, HER2-negative metastatic...
Fulvestrant Plus Everolimus: New Second-Line Option for Postmenopausal Metastatic Breast Cancer
The addition of everolimus (Afinitor) to fulvestrant (Faslodex) doubled progression-free survival in postmenopausal women with hormone receptor–positive, HER2-negative metastatic breast cancer resistant to aromatase inhibitor therapy compared with fulvestrant plus placebo, according to the...
Confirmation or Transformation? The Case of Palbociclib in Hormone Receptor–Positive Metastatic Breast Cancer
Women with hormone receptor–positive metastatic breast cancer are witnessing an unprecedented time of success in the battle against their disease. Just in the past 12 months, a number of prospective, randomized, phase III studies were reported, with positive results indicating the value of...
Phase III Trial Shows Improved Progression-Free Survival With Fulvestrant vs Anastrozole in Hormone Receptor–Positive Advanced Breast Cancer
In the international phase III FALCON trial reported in The Lancet, Robertson et al found that progression-free survival was improved with intramuscular fulvestrant (Faslodex) vs oral anastrozole in endocrine therapy–naive women with hormone receptor–positive locally advanced or...
SABCS 2016: BELLE-3 Trial of Buparlisib Plus Endocrine Therapy Meets Primary Endpoint of Progression-Free Survival in Breast Cancer Patients
The investigational PI3K inhibitor buparlisib, in combination with endocrine therapy, improved outcomes for patients with hormone receptor–positive advanced breast cancer that had progressed after treatment with everolimus (Afinitor) plus exemestane, according to data from the phase III...
SABCS 2016: Adding Everolimus to Fulvestrant Improved Outcomes for Postmenopausal Patients With Hormone Receptor–Positive Breast Cancer
Progression-free survival was more than doubled for patients with metastatic hormone receptor–positive, HER2-negative breast cancer resistant to aromatase inhibitor therapy by adding everolimus (Afinitor) to treatment with the endocrine therapeutic fulvestrant (Faslodex), according to data...
Clinical Strategies for Improving Endocrine Therapy in Metastatic Breast Cancer
Most women with hormone receptor–positive breast cancer receive endocrine therapy as part of their treatment, but “the reality is that patients who receive antihormone therapy in the metastatic disease setting ultimately develop disease progression, ” William J. Gradishar, MD, stated at the 18th...
Fulvestrant Superior to Anastrozole as Initial Therapy in Advanced Breast Cancer
Fulvestrant (Faslodex) was superior to anastrozole as initial treatment of hormone receptor–positive, endocrine therapy–naive, advanced breast cancer, significantly reducing the risk of disease progression or death, according to the results of the phase III FALCON study presented at the 2016...
Clinical Trials Actively Recruiting Patients With Metastatic Breast Cancer
Pilot Study Title: Pilot Study of 18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole-Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain Study Type: Pilot/interventional/parallel assignment Study Sponsor ...
Expert Point of View: Stephen R.D. Johnston, MD
“These results apply to about two-thirds of women with advanced breast cancer, ie, those with hormone receptor–positive metastatic breast cancer,” noted the formal discussant of this paper, Stephen R.D. Johnston, MD, of the Royal Marsden Hospital, London. “At present with first-line endocrine...
Combination of Ribociclib and Letrozole Improved Progression-Free Survival in Hormone Receptor–Positive Advanced Breast Cancer
The combination of the selective CDK4/6 inhibitor ribociclib plus letrozole significantly improved progression-free survival in hormone receptor–positive advanced breast cancer. When ribociclib was added to letrozole, progression-free survival improved by 44% compared with letrozole alone,...
ESMO 2016: Fulvestrant Improves Progression-Free Survival in Advanced Breast Cancer
Fulvestrant (Faslodex) significantly increases progression-free survival in women with hormone receptor–positive advanced breast cancer, particularly those with less aggressive lower-volume disease, Ellis et al reported at the 2016 European Society for Medical Oncology (ESMO) Congress in ...
ASCO Guideline on Endocrine Therapy for Metastatic Breast Cancer: Reaffirming Principles for Making Treatment Decisions
The role of endocrine therapy for hormone receptor–positive metastatic breast cancer is well established, and clinicians are strongly encouraged to consider one of several therapeutic options for the majority of patients who present with metastatic disease. The recent ASCO guideline on this topic, ...
ASCO Guideline on Endocrine Therapy for Hormone Receptor–Positive Metastatic Breast Cancer
As reported by Hope S. Rugo, MD, of the University of California San Francisco Comprehensive Cancer Center, and colleagues in the Journal of Clinical Oncology, ASCO has released a clinical practice guideline on endocrine therapy for hormone receptor–positive metastatic breast cancer.1 The...
Quick Takes on Promising New Approaches to Treating Breast Cancer
At the 2016 ASCO Annual Meeting, researchers reported encouraging results for several new drugs and treatment strategies for breast cancer. The ASCO Post brings you brief summaries of a select few. Abemaciclib Trial The cyclin-dependent kinase 4/6 (CDK4/6) inhibitor abemaciclib produced responses...
PALOMA-3 Trial in HER2-Negative Metastatic Breast Cancer: Challenge of Moving Beyond Estrogen Receptor Positivity
Hormone receptor–positive breast cancer represents the largest therapeutic subgroup of the disease. The development of endocrine therapies has shaped the treatment paradigm for both advanced- and early-stage disease for decades.1 Still, despite their significant impact, advanced breast cancer...
Prolonged Progression-Free Survival With Addition of Palbociclib to Fulvestrant in HER2-Negative Metastatic Breast Cancer
As reported in The Lancet Oncology by Massimo Cristofanilli, MD, of the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, and colleagues, the final results of the phase III PALOMA-3 trial showed that the addition of the CDK4/CDK6 inhibitor palbociclib (Ibrance) to fulvestrant...
Lisa A. Carey, MD, and Nicholas C. Turner, MD, PhD, on PALOMA-2 and -3 Study Findings in Advanced Breast Cancer
Lisa A. Carey, MD, of the University of North Carolina, and Nicholas C. Turner, MD, PhD, of The Royal Marsden Hospital and Institute of Cancer Research, discuss the efficacy of palbociclib plus fulvestrant in patients with ESR1 mutations in circulating tumor DNA, and palbociclib and letrozole for...
ASCO Guideline on Endocrine Therapy for Hormone Receptor–Positive Metastatic Breast Cancer
As reported by Hope S. Rugo, MD, of the University of California San Francisco Comprehensive Cancer Center, and colleagues in the Journal of Clinical Oncology, ASCO has released a clinical practice guideline on endocrine therapy for hormone receptor–positive metastatic breast cancer. The...
