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Showing 101 - 150Phase III PADA-1 Trial Examines the Impact of ESR1 Mutations in Metastatic Breast Cancer
ESR1 mutations are known to confer resistance to endocrine therapy in the metastatic breast cancer setting. These mutations herald a poor prognosis, so their clearance early in the treatment course may greatly reduce the risk of recurrence, according to the early results of the prospective phase...
Expert Point of View: Komal Jhaveri, MD
“Surprisingly, the phase II PARSIFAL trial did not show a statistical superiority in progression-free survival for fulvestrant plus palbociclib over letrozole plus palbociclib in the first-line treatment of patients with endocrine-sensitive, metastatic breast cancer. The noninferiority hypothesis...
When Paired With Palbociclib, Fulvestrant and Letrozole Yield Comparable Results in PARSIFAL Trial
When paired with palbociclib in the first-line treatment of metastatic breast cancer, fulvestrant and letrozole performed comparably, with no statistical superiority in progression-free or overall survival shown for either endocrine agent, in the phase II PARSIFAL study presented during the ASCO20...
Double PIK3CA Mutations and Response Benefit in Breast Cancer
Patients who have breast cancers with double PIK3CA mutations seem to have a more robust response to PI3Kα inhibitors than those with a single PIK3CA mutation, based on an analysis of the phase III SANDPIPER trial, which tested taselisib plus fulvestrant, according to a presentation during the 2020 ...
Alpelisib Deemed Effective in Advanced Breast Cancer After Treatment With CDK4/6 Inhibitor
The phase II BYLieve trial indicates the effectiveness of the PIK3CA inhibitor alpelisib in patients with PIK3CA-positive, hormone receptor–positive/HER2-negative advanced breast cancer previously treated with a cyclin-dependent kinase (CDK) 4/6 inhibitor plus an aromatase inhibitor. These results...
Expert Point of View: Komal Jhaveri, MD, FACP
Komal Jhaveri, MD, FACP, Attending Physician at Memorial Sloan Kettering Cancer Center, Clinical Director of the Early Drug Development Service, and Assistant Professor of Medicine at Weill Cornell Medical College, served as the study’s invited discussant. Dr. Jhaveri noted that, in SOLAR-1, the...
Study Finds Alpelisib Effective After CDK4/6 Inhibition in Advanced Breast Cancer
The PIK3CA inhibitor alpelisib appears to be effective in patients with PIK3CA-positive, hormone receptor–positive/HER2-negative advanced breast cancer previously treated with a cyclin-dependent kinase (CDK) 4/6 inhibitor plus an aromatase inhibitor, according to the phase II BYLieve trial.1 More...
Studies Show Circulating Tumor Material May Predict Outcomes After Neoadjuvant Therapy for Breast Cancer
In early triple-negative breast cancer, the presence of circulating tumor DNA (ctDNA) and circulating tumor cells after neoadjuvant chemotherapy may enable risk stratification of patients for disease recurrence and may predict outcomes, according to a preplanned correlative analysis of the phase II ...
Abemaciclib/Fulvestrant/Trastuzumab for Patients With Previously Treated HR-Positive, HER2-Positive Advanced Breast Cancer
In the phase II monarcHER trial reported in The Lancet Oncology, Sara M. Tolaney, MD, and colleagues found that the combination of abemaciclib, fulvestrant, and trastuzumab prolonged progression-free survival vs trastuzumab plus standard-of-care chemotherapy in patients with previously treated...
Beyond CDK4/6 Inhibitors: What Subsequent Treatment Is Best?
Inhibitors of cyclin-dependent kinases 4 and 6 (CDK4/6) have changed the natural history of hormone receptor–positive metastatic breast cancer. While median progression-free survival on these drugs is approximately 27 months, the disease eventually progresses and clinicians must choose a subsequent ...
Brief Highlights From the 2019 San Antonio Breast Cancer Symposium
In addition to our regular coverage of the 2019 San Antonio Breast Cancer Symposium, the following reports from the meeting include studies you may have missed. We hope you find them of interest. Ribociclib/Letrozole as Neoadjuvant Therapy As neoadjuvant therapy in women with high-risk hormone...
Addition of Capivasertib to Fulvestrant in Advanced ER-Positive Breast Cancer After Relapse or Disease Progression With Aromatase Inhibitor Treatment
In the phase II FAKTION trial reported in The Lancet Oncology, Jones et al found that the addition of the AKT inhibitor capivasertib to endocrine therapy with fulvestrant prolonged progression-free survival in postmenopausal women with aromatase inhibitor–resistant, estrogen receptor (ER)-positive, ...
Real-World Use of Palbociclib and Abemaciclib Explored in Two Studies Based on Electronic Health Records Database
Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors are changing the landscape of the treatment of hormone receptor (HR)-positive/HER2-negative breast cancer. Three CDK4/6 inhibitors are approved by the U.S. Food and Drug Administration—ribociclib, palbociclib, and abemaciclib—as first- or...
FDA Pooled Analysis of CDK4/6 Inhibitor Treatment for Advanced Hormone Receptor–Positive, HER2-Negative Breast Cancer
In a U.S. Food and Drug Administration (FDA) pooled analysis reported in The Lancet Oncology, Jennifer J. Gao, MD, and colleagues found that the magnitude of progression-free survival benefit with the addition of a cyclin-dependent kinase (CDK) 4/6 inhibitor to endocrine therapy in women with...
Companion Diagnostic Approved for Alpelisib/Fulvestrant Therapy
On December 4, the U.S. Food and Drug Administration (FDA) approved FoundationOne CDx to be used as a companion diagnostic for alpelisib in combination with fulvestrant for the treatment of postmenopausal women as well as male patients with hormone receptor–positive, HER2-negative, PIK3CA-mutated,...
FDA Approves FoundationOne CDx as a Companion Diagnostic for Alpelisib/Fulvestrant Treatment in Breast Cancer
On December 4, the U.S. Food and Drug Administration (FDA) approved FoundationOne CDx to be used as a companion diagnostic for alpelisib in combination with fulvestrant for the treatment of postmenopausal female patients as well as male patients with hormone receptor (HR)-positive, HER2-negative,...
MONALEESA-3, MONARCH 2: CDK4/6 Inhibitors Plus Fulvestrant Benefit Survival in Advanced Breast Cancer
CDK4/6 inhibitors improve overall survival in advanced breast cancer, according to results of two important phase III trials reported at the ESMO Congress 2019. Dennis J. Slamon, MD, PhD, of the University of California, Los Angeles Women’s Cancer Research Program, presented the findings from the...
MONARCH 2: Interim Analysis of Overall Survival With Abemaciclib/Fulvestrant in Hormone Receptor–Positive, HER2-Negative Breast Cancer
As reported in JAMA Oncology by George W. Sledge, Jr, MD, and colleagues, an interim analysis of overall survival in the phase III MONARCH 2 trial has shown a significant advantage for abemaciclib plus fulvestrant vs fulvestrant alone in women with advanced hormone receptor–positive, HER2-negative...
Landmark Studies Show Clear Overall Survival Benefit for CDK4/6 Inhibitors in Advanced Breast Cancer
CDK4/6 inhibitors clearly improve overall survival in advanced breast cancer, as this prized endpoint was robustly demonstrated in two landmark phase III trials reported at the European Society for Medical Oncology (ESMO) Congress 2019. Dennis J. Slamon, MD, PhD, of the University of California,...
Meta-analysis of Chemotherapy and Hormonal Treatments for Postmenopausal Women With Metastatic Breast Cancer
In a systematic review and network meta-analysis reported in The Lancet Oncology, Giuliano et al found that progression-free survival in postmenopausal women with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer was improved with first- or second-line CDK4/6 inhibitors plus...
Alpelisib for PIK3CA-Mutated Advanced Breast Cancer
On May 24, 2019, alpelisib was approved for use in combination with fulvestrant for postmenopausal women, and men, with hormone receptor–positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer, as detected by a U.S. Food and Drug Administration (FDA)-approved test following...
Tumor Size and Grade Matter, and Ovarian Ablation by Chemotherapy May Explain Subgroup Anomaly in TAILORx
At the 2019 ASCO Annual Meeting, and simultaneously in The New England Journal of Medicine, we heard the third paper reporting results from TAILORx.1,2 The first, in 2015,3 indicated that women with node-negative breast cancers with Oncotype DX recurrence scores less than 11 did extremely well...
Alpelisib Plus Fulvestrant Approved for PIK3CA-Mutated Breast Cancer
On May 24, the U.S. Food and Drug Administration (FDA) approved the PIK3CA inhibitor alpelisib (Piqray) tablets to be used in combination with the FDA-approved endocrine therapy fulvestrant to treat postmenopausal women and men with hormone receptor–positive, HER2-negative, PIK3CA-mutated, advanced ...
Expert Point of View: Harold Burstein, MD, PhD, FASCO, and Jame Abraham, MD, FACP
Harold Burstein, MD, PhD, FASCO, Associate Professor of Medicine at Dana-Farber Cancer Institute, Boston, and Jame Abraham, MD, FACP, Director of the Breast Oncology Program at Taussig Cancer Institute and Co-Director of the Cleveland Clinic Comprehensive Breast Cancer Program, commented on what...
FDA Approves Alpelisib in Combination With Fulvestrant for PIK3CA-Mutated, Hormone Receptor–Positive Advanced Breast Cancer
On May 24, the U.S. Food and Drug Administration (FDA) approved alpelisib (Piqray) tablets to be used in combination with the FDA-approved endocrine therapy fulvestrant to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2...
Fulvestrant/Anastrozole in Metastatic Breast Cancer
As reported in The New England Journal of Medicine by Rita S. Mehta, MD, and colleagues, the final overall survival results of the phase III SWOG S0226 trial show that the addition of first-line fulvestrant to anastrozole was associated with improved overall survival in postmenopausal women with...
Postprogression Treatment of Estrogen Receptor–Positive Breast Cancer: Future Approaches
AT THE 2019 Miami Breast Cancer Conference, William J. Gradishar, MD, FASCO, presented a vision of the future in the treatment of advanced hormone receptor–positive breast cancer.1 The refinement of disease subsets, the development of agents targeting the PI3K/AKT/mTOR pathway, the use of novel...
Biomarkers Can Now Help Guide Treatment Selections in Breast Cancer
A growing list of biomarkers is beginning to drive targeted therapy in breast cancer, and clinicians can take advantage of these assays to make treatment selections, Debu Tripathy, MD, Professor of Medicine and Chair of Breast Medical Oncology at The University of Texas MD Anderson Cancer Center,...
Final Overall Survival Results With Fulvestrant Plus Anastrozole in Metastatic Breast Cancer
As reported in The New England Journal of Medicine by Mehta et al, the final overall survival results of the phase III SWOG S0226 trial show that the addition of first-line fulvestrant to anastrozole was associated with improved overall survival in postmenopausal women with hormone...
FDA Expands Palbociclib Indication in HR-Positive, HER2-Negative Breast Cancer to Include Male Patients
Today, the U.S. Food and Drug Administration (FDA) extended the indication of palbociclib (Ibrance) capsules in combination with specific endocrine therapies for hormone receptor (HR)–positive, HER2-negative advanced or metastatic breast cancer to include male patients. “Today, we are...
SABCS Presentations Offer New Data on Biomarkers and Novel Treatment Approaches in Early and Metastatic Breast Cancers
REPORTERS FOR The ASCO Post captured the following summaries of noteworthy studies presented at the 2018 San Antonio Breast Cancer Symposium. In HER2-Negative Metastatic Disease, CTCs Frequently HER2-Positive ALMOST HALF of all patients with HER2-negative metastatic breast cancer have circulating...
Challenge Moving Forward in Breast Cancer Treatment: To Show That New Approaches Change Outcomes
ADVANCES IN treating breast cancer over the past 20 years have brought us to the point where treatment can be confidently de-escalated for some patients, and immunotherapy and precision decision-making may change the way breast cancer is treated for others, William Gradishar MD, FASCO, told the...
Hope S. Rugo, MD, on Metastatic Breast Cancer: Treatment for Pretreated Hormone Receptor–Positive Disease
Hope S. Rugo, MD, of the University of California, San Francisco, discusses how treatment with a lower dose of palbociclib (100 mg vs 125 mg) in combination with fulvestrant or tamoxifen is associated with a lower rate of high-grade neutropenia (Abstract PD2-12).
SABCS 2018: SOLAR-1: Liquid Biopsies in Predicting Benefit of Alpelisib in PIK3CA-Mutant Breast Cancer
Liquid biopsy–based assessment of PIK3CA mutational status served as a better indicator of progression-free survival compared with analysis of tissue biopsy in patients with breast cancer enrolled in the phase III SOLAR-1 clinical trial, according to data presented by Juric et al at the 2018...
ESMO 2018: PALOMA-3: Palbociclib in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
Treatment with the cyclin-dependent kinase (CDK) 4/6 inhibitor palbociclib (Ibrance) achieved a clinically meaningful improvement in overall survival in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer that has relapsed or ...
Actively Recruiting Clinical Trials Focused on Targeted Therapy for HER2-Positive Breast Cancer
THE INFORMATION contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on targeted therapy in HER2-positive breast cancer. These trials are studying imaging as a predictor of treatment response, combination therapies, treatments for metastatic...
Ribociclib in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 18, 2018, the indication for ribociclib (Kisqali) ...
FDA Expands Ribociclib Indication in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
On July 18, 2018, the U.S. Food and Drug Administration (FDA) expanded the indication for ribociclib (Kisqali), in combination with an aromatase inhibitor for pre/perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based...
In Case You Missed It: Update on Breast Cancer Research
The ASCO Post presents these brief summaries of important studies in breast cancer, presented at the 2018 ASCO Annual Meeting. Ribociclib Plus Fulvestrant in Metastatic Breast Cancer The benefit of an inhibitor of cyclin-dependent kinase 4/6 (CDK4/6) added to fulvestrant has now been proven to...
FDA Expands Ribociclib Indication in Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer
Today, the U.S. Food and Drug Administration (FDA) expanded the indication for ribociclib (Kisqali) in combination with an aromatase inhibitor for premenopausal or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer as initial...
Study of PI3K Inhibitor Added to Fulvestrant in Advanced Breast Cancer Affirms Proof-of-Principle
IN PATIENTS with advanced breast cancer harboring a PIK3CA mutation, the addition of the PI3 kinase (PI3K) inhibitor taselisib to endocrine therapy with fulvestrant (Faslodex) significantly improved progression-free survival compared with fulvestrant alone, in the international phase III SANDPIPER...
Pooled Study Analysis Explores the Use of CDK4/6 Inhibitors in Metastatic Breast Cancer
RESEARCH TO DATE has not been able to identify a subgroup of patients with estrogen receptor–positive HER2-negative metastatic breast cancer who do not derive benefit from the addition of inhibitors of cyclin-dependent kinases 4/6 (CDK4/6) to endocrine therapy, according to a study by the U.S. Food ...
2018 ASCO: Phase III SANDPIPER Trial Evaluates Taselisib Plus Fulvestrant in Advanced Breast Cancer
In a phase III clinical trial, the investigational PI3K inhibitor taselisib combined with standard hormone therapy fulvestrant (Faslodex) halted the growth of advanced breast cancer growth by 2 months longer than hormone therapy alone. In addition, the novel combination decreased the chance of...
FDA Oncology Drug Approvals Granted Between June 2017 and May 16, 2018
Over the past year (June 2017–May 2018), the U.S. Food and Drug Administration (FDA) granted approval to a number of new oncology drug products, including several biosimilar products. Here we provide the labeling approved for these novel drugs and new indications. EPOETIN ALFA-EPBX (RETACRIT)...
Endocrine Therapy: An Important Treatment Limited by Major Challenges
“Endocrine therapy remains the most effective and least toxic treatment for breast cancer, but we have many problems to solve. And there will have to be many different solutions,” according to George W. Sledge, MD, FASCO, Professor of Medicine and Chief of the Division of Oncology at Stanford...
Addition of Everolimus to Fulvestrant in HR-Positive, HER2-Negative, Aromatase Inhibitor–Resistant Metastatic Breast Cancer
In the phase II PrE0102 trial reported in the Journal of Clinical Oncology by Kornblum et al, the addition of everolimus to fulvestrant (Faslodex) improved progression-free survival in postmenopausal women with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer resistant to...
How Will ctDNA Assays Aid in Managing Breast Cancer?
CIRCULATING TUMOR DNA (ctDNA) assays are now commercially available for use in lung cancer and melanoma, where they can identify the presence of specific mutations that drive treatment selection. In breast cancer, ctDNA remains more of a research tool, but this is poised to change. At the 2018...
AACR 2018: Acquired HER2 Mutations Confer Resistance to Hormone Therapy in ER-Positive Metastatic Breast Cancer
Mutations in HER2 were found to confer resistance to hormone therapy in some estrogen receptor (ER)-positive metastatic breast cancer cases, and resistance could be reversed by dual treatment with the hormone therapy fulvestrant (Faslodex) and the HER2 kinase inhibitor neratinib (Nerlynx),...
Fulvestrant Monotherapy for Postmenopausal Women With Advanced Breast Cancer
On August 28, 2017, fulvestrant (Faslodex) was approved at 500 mg as monotherapy for expanded use in postmenopausal women with hormone receptor–positive, HER2-negative advanced breast cancer who have not received previous endocrine therapy.1 Supporting Efficacy Data Approval was based on improved...
Ribociclib Doubles Progression-Free Survival in Premenopausal Breast Cancer
PREMENOPAUSAL WOMEN with hormone receptor–positive, HER2-negative advanced breast cancer benefited substantially from the addition of ribociclib (Kisqali) to first-line endocrine therapy plus medical ovarian suppression, according to results from the MONALEESA-7 study.1 At the 2017 San Antonio...
