Based on the findings of the VERITAC-2 trial, treatment with the selective PROTAC (proteolysis targeting chimera) estrogen receptor degrader vepdegestrant yielded statistically significant and clinically meaningful improvement in progression-free survival in patients with ESR1-mutant, estrogen...
“Inavolisib plus palbociclib and fulvestrant significantly improved overall survival compared with placebo plus palbociclib/fulvestrant…. This is the first time overall survival has been significantly improved by a PI3K pathway–targeted drug,” said Nicholas Turner, MD, PhD, FRCP,FMedSci, who...
Results from VERITAC-2 trial showed that the proteolysis-targeting chimera (PROTAC) vepdegestrant could extend progression-free survival for people with previously treated estrogen receptor (ER)-positive, HER2-negative advanced breast cancer with an ESR1 mutation. The research will be presented at...
New findings from the phase III INAVO120 trial showed that adding inavolisib to palbociclib and fulvestrant may help extend survival and delay the time until treatment with chemotherapy in previously treated patients with PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer. The...
In a phase IIa study reported in The Lancet Oncology, Escrivá-de-Romani et al evaluated whether the chemotherapy-free triplet of the HER2-targeted bispecific antibody zanidatamab plus palbociclib and fulvestrant showed activity in heavily pretreated patients with hormone receptor (HR)-positive,...
Arvinas, Inc. and Pfizer Inc. recently announced results from the randomized phase III VERITAC-2 clinical trial (ClinicalTrials.gov identifier NCT05654623) evaluating vepdegestrant monotherapy vs fulvestrant in adults with estrogen receptor–positive, HER2-negative advanced or metastatic breast...
Among the high-quality abstract presentations at the 2024 San Antonio Breast Cancer Symposium (SABCS), a few always stand out as particularly meritorious. Each year, The ASCO Post asks our Deputy Editor, breast cancer specialist Jame Abraham, MD, FACP, to give us his picks. Dr. Abraham is Chairman...
The investigational next-generation oral selective estrogen receptor degrader (SERD) imlunestrant improved progression-free survival both as monotherapy in patients with ESR1 mutations and in combination with the CDK4/6 inhibitor abemaciclib regardless of ESR1 mutational status in patients with...
Addition of the CDK4/6 inhibitor palbociclib to the current standard of care for first-line maintenance therapy after induction chemotherapy achieved statistically significant and clinically meaningful improvements in progression-free survival in patients with hormone receptor (HR)-positive,...
In a phase III trial (INAVO120) reported in The New England Journal of Medicine, Nicholas C. Turner, MD, PhD, of Royal Marsden Hospital and the Institute of Cancer Research, London, and colleagues found that the addition of inavolisib to palbociclib/fulvestrant improved progression-free survival...
The U.S. Food and Drug Administration (FDA) approved the PI3K inhibitor inavolisib (Itovebi) with the CDK4/6 inhibitor palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer, as...
On November 16, 2023, capivasertib (Truqap) was approved for use with fulvestrant for patients with hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations, following disease progression on at least one endocrine-based...
Suppression of the estrogen receptor has proven to be an effective treatment for hormone receptor–positive breast cancer, but standard endocrine therapies have liabilities that are not limited to their pharmacokinetics or toxicity profiles, which allow for ligand-independent estrogen receptor...
For breast cancer that is estrogen receptor–positive, CDK4/6 inhibitors, given with endocrine therapy, have become the standard of care, especially in metastatic disease. However, resistance to both endocrine therapies and CDK4/6 inhibitors is common, and new approaches are needed to counteract...
The National Comprehensive Cancer Network® published its first set of Clinical Practice Guidelines in Oncology (NCCN Guidelines®) in 1996, covering eight tumor types. Currently, guidelines are available for more than 60 tumor types, subtypes, and related topics. The NCCN’s 29th Annual Conference...
Patients with estrogen receptor–positive, HER2-negative metastatic breast cancer now have a new medication option that extends survival, according to an ASCO rapid guideline update.1 The update was designed to orient clinicians to outcomes from the CAPItello-291 trial, which led to the U.S. Food...
In the phase II PACE trial reported in the Journal of Clinical Oncology, Erica L. Mayer, MD, MPH, and colleagues found no improvement in progression-free survival with the addition of palbociclib to fulvestrant—but a numeric improvement with the further addition of avelumab—in patients with hormone ...
This is Part 3 of Targeting Endocrine Resistance in HR-Positive/HER2-Negative Metastatic Breast Cancer, a three-part video roundtable series. Scroll down to watch the other videos from this Roundtable. In this video, Drs. Kevin Kalinsky, Manali Bhave, and Ruth O’Regan discuss the treatment of...
Studies presented at the 2023 San Antonio Breast Cancer Symposium (SABCS) significantly moved the needle forward in our treatment of breast cancer. We are increasingly learning how to stratify risk, so we can optimize therapy and minimize our patients’ exposure to treatments that will not be...
The addition of inavolisib to first-line treatment with palbociclib plus fulvestrant more than doubled progression-free survival in patients with recurrent PIK3CA-mutated, hormone receptor–positive, HER2-negative advanced breast cancer, according to a late-breaking primary analysis of the phase III ...
The addition of inavolisib to first-line treatment with palbociclib plus fulvestrant more than doubled progression-free survival in patients with recurrent PIK3CA-mutated, hormone receptor–positive, HER2-negative advanced breast cancer, according to a late-breaking primary analysis of the phase III ...
Two studies led by researchers at The University of Texas MD Anderson Cancer Center demonstrated clinical benefit from novel targeted therapies, which may offer new treatment options for patients with metastatic hormone receptor–positive/HER2-negative breast cancer. The data were shared in oral...
On November 16, 2023, the U.S. Food and Drug Administration (FDA) approved capivasertib (Truqap) with fulvestrant for adult patients with hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations, as detected by an...
The past year has been an exciting time for breast oncologists and patients with all stages of breast cancer, with new agents approved and long-term results from pivotal trials showing improved survival for patients with metastatic disease. Let’s take a look at some of the highlights in early-stage ...
The MONARCH 3 study’s invited discussant, Meritxell Bellet Ezquerra, MD, PhD, a senior researcher at the Vall d’Hebron Institute of Oncology in Barcelona, commented: “The second interim analysis for overall survival in MONARCH 31 indicates a positive trend, which was also observed for the subgroup...
Virginia Kaklamani, MD, Professor of Medicine at the University of Texas (UT) Health Science Center San Antonio and leader of the Breast Cancer Program at UT Health San Antonio MD Anderson Cancer Center, was enthusiastic about the results of the phase III CAPItello-291 trial. “The phase III...
The combination of capivasertib, an AKT pathway inhibitor, plus fulvestrant, an estrogen receptor antagonist, significantly improved progression-free survival compared with fulvestrant alone in patients with hormone receptor–positive, HER2-negative advanced breast cancer, according to results of...
The combination of palbociclib and fulvestrant did not prolong progression-free survival compared to fulvestrant alone in patients with hormone receptor–positive/HER2-negative metastatic breast cancer who had disease progression on prior treatment with a CDK4/6 inhibitor and endocrine therapy,...
Elacestrant—an investigational oral selective estrogen receptor degrader (SERD)—achieved longer progression-free survival vs standard-of-care endocrine monotherapy as second- or third-line therapy in patients with estrogen receptor–positive, HER2-negative advanced or metastatic breast cancer in the ...
Researchers have uncovered elevated rates of hyperglycemia among patients who have breast cancer receiving treatment with alpelisib, according to a recent study published by Shen et al in Cancer. Background Alpelisib is designed to target the phosphoinositide 3-kinase (PI3K) protein, which is...
Testing for the emergence of ESR1 mutations should be routine at disease recurrence or progression for patients with estrogen receptor (ER)-positive, HER2-negative metastatic breast cancer whose disease is being managed with endocrine therapy, according to an ASCO guideline rapid recommendation...
The National Cancer Institute (NCI) has launched a new set of large, precision medicine–based clinical trials—known as the ComboMATCH initiative—that will examine the efficacy of novel drug combinations targeting specific tumor mutations in adult and pediatric patients with cancer. The new...
In the phase II MAINTAIN trial reported in the Journal of Clinical Oncology, Kevin Kalinsky, MD, MS, and colleagues found that a switch in endocrine therapy plus continued CDK4/6 inhibitor treatment with ribociclib was associated with improved progression-free survival in patients with hormone...
Adding the CDK4/6 inhibitor ribociclib to endocrine therapy resulted in a significant improvement in invasive disease–free survival for patients with hormone receptor–positive, HER2-negative early-stage breast cancer. Findings from the phase III NATALEE trial were presented by Dennis J. Slamon, MD, ...
In a single-institution cohort study reported in JAMA Network Open, Jason A. Mouabbi, MD, and colleagues found no difference in survival outcomes between patients with hormone receptor–positive metastatic breast cancer with low vs no HER2 expression who received targeted therapy and endocrine...
In hormone receptor–positive metastatic breast cancer, tumors eventually become resistant not only to endocrine blockade but to inhibitors of cyclin-dependent kinases 4 and 6 (CDK4/6). This obstacle to successful treatment is being tackled with novel hormone receptor–directed therapies, with the...
In hormone receptor–positive breast cancer, the ability to successfully target key mediators of endocrine resistance is changing the outlook of metastatic disease in this subtype, according to Aditya Bardia, MD, MPH, FASCO, Director of Breast Cancer Research and Associate Professor at Harvard...
In the phase II TBCRC041 trial reported in JAMA Oncology, Haddad et al found that the addition of fulvestrant to alisertib did not improve objective response rate in postmenopausal patients with HER2-negative, endocrine-resistant metastatic breast cancer. Study Details The multicenter trial,...
Among the high-quality abstract presentations at the San Antonio Breast Cancer Symposium (SABCS), a few always stand out as particularly meritorious. Each year, The ASCOPost asks our Associate Editor, breast cancer specialist Jame Abraham, MD, FACP, to give us his picks. Dr. Abraham is Chairman of ...
On January 27, 2023, elacestrant was approved by the U.S. Food and Drug Administration (FDA) for postmenopausal women or adult men with estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine ...
On January 27, the U.S. Food and Drug Administration (FDA) approved elacestrant (Orserdu) for postmenopausal women or adult men with estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine...
The combination of palbociclib and fulvestrant did not prolong progression-free survival compared to fulvestrant alone in patients with hormone receptor–positive/HER2-negative metastatic breast cancer who had disease progression on prior treatment with a CDK4/6 inhibitor and endocrine therapy,...
The oral selective estrogen receptor degrader (SERD) camizestrant improved progression-free survival, as compared with fulvestrant, in previously treated postmenopausal women with advanced breast cancer in the phase II SERENA-2 trial. These results were reported at the 2022 San Antonio Breast...
Virginia Kaklamani, MD, Professor of Medicine at the University of Texas (UT) Health Science Center San Antonio and leader of the Breast Cancer Program at UT Health San Antonio MD Anderson Cancer Center, was enthusiastic about the results of the phase III CAPItello-291 trial. “The phase III...
The combination of capivasertib, an AKT pathway inhibitor, plus fulvestrant, an estrogen receptor antagonist, significantly improved progression-free survival compared with fulvestrant alone in patients with hormone receptor–positive, HER2-negative advanced breast cancer, according to results of...
Elacestrant—an investigational oral selective estrogen receptor degrader (SERD)—achieved longer progression-free survival vs standard-of-care endocrine monotherapy as second- or third-line therapy in patients with estrogen receptor–positive, HER2-negative advanced or metastatic breast cancer in the ...
Elacestrant—an investigational oral selective estrogen receptor degrader (SERD)—achieved longer progression-free survival vs standard-of-care endocrine monotherapy as second- or third-line therapy in patients with estrogen receptor (ER)-positive, HER2-negative, advanced or metastatic breast cancer...
Molecular testing and genomic testing are now considered standard of care in breast cancer, guiding treatment decisions in early breast cancer and targeted therapies in the metastatic setting. “But tumors evolve,” Virginia Kaklamani, MD, DSc, reminded participants at the 2022 Lynn Sage Breast...
The MONARCH 3 study’s invited discussant, Meritxell Bellet Ezquerra, MD, PhD, a senior researcher at the Vall d’Hebron Institute of Oncology in Barcelona, commented: “The second interim analysis for overall survival in MONARCH 31 indicates a positive trend, which was also observed for the subgroup...
Endocrine therapy is the foundation of first-line therapy in most patients with hormone receptor–positive, HER2-negative metastatic breast cancer. Many of these patients respond to endocrine therapy but eventually become resistant to it through both intrinsic and acquired resistance mechanisms....