The past year has seen an unprecedented number of practice-changing advances across all three major breast cancer subtypes. For patients with early-stage triple-negative breast cancer, neoadjuvant chemotherapy plus pembrolizumab firmly entered the standard of care based on improvements in...
In the past year, the U.S. Food and Drug Administration (FDA) approved four treatment options for patients with breast cancer, which are summarized herein.
T-DXd for HER2-Low Breast Cancer
On August 5, 2022, the FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu; T-DXd) for adult patients with ...
Longer-term follow-up of the global phase III monarchE trial showed an increasing benefit for adding abemaciclib to endocrine therapy in the adjuvant treatment of early high-risk hormone receptor–positive, HER2-negative breast cancer, regardless of Ki67 index. The latest findings were reported at a ...
Use of the first investigational oral selective estrogen receptor degrader (SERD) elacestrant significantly reduced the risk of death or disease progression and lengthened progression-free survival compared with standard-of-care endocrine therapy with fulvestrant or an aromatase inhibitor in...
New drugs for HER2-positive breast cancer are able to overcome some of the obstacles that have made brain metastases challenging to treat, according to Mark Pegram, MD, the Susy Yuan-Huey Hung Professor of Oncology at Stanford University School of Medicine in California, who described the promising ...
The OlympiA trial of adjuvant olaparib in patients with HER2-negative, high-risk early-stage breast cancer and BRCA1 and BRCA2 mutations has now demonstrated a significant overall survival benefit, reducing the risk of death over placebo by 32% and yielding an absolute improvement of 3.8% at 3...
Patients with advanced HER2-negative metastatic breast cancer and high tumor mutational burden achieved responses—often durable—from treatment with the immunotherapy doublet of nivolumab and ipilimumab, according to results of the phase II NIMBUS trial reported at the 2021 San Antonio Breast Cancer ...
Switching from an aromatase inhibitor to fulvestrant upon early identification of the ESR1 mutation in plasma—before disease progression—doubled progression-free survival in the phase III PADA-1 trial, presented at the 2021 San Antonio Breast Cancer Symposium.1
“PADA-1 is the first trial to...
Preliminary results of the basket BEGONIA trial showed that the antibody-drug conjugate datopotamab deruxtecan (Dato-DXd), paired with the immune checkpoint inhibitor durvalumab, has strong activity in advanced or metastatic triple-negative breast cancer among patients not biomarker-selected for...
As reported in The New England Journal of Medicine by Peter Schmid, MD, PhD, of Barts Cancer Institute, Queen Mary University of London, and colleagues, a preplanned interim analysis of the phase III KEYNOTE-522 trial has shown improved event-free survival with the addition of pembrolizumab to...
Datopotamab deruxtecan, an antibody-drug conjugate directed against trophoblast cell surface antigen-2 (Trop-2), is showing promise as a treatment for relapsed or refractory advanced triple-negative breast cancer, according to early findings from the phase I TROPION-PanTumor01 trial presented...
The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) doubled progression-free survival compared with chemotherapy alone in patients with “HER2-low” metastatic breast cancer—ie, patients with low levels of HER2 expression. The agent also extended overall survival for patients with low ...
In the single-center phase II TUXEDO-1 trial of patients with advanced HER2-positive breast cancer, fam-trastuzumab-deruxtecan-nxki (T-DXd) showed efficacy in patients with active brain metastases, yielding intracranial responses in 73.3% of the population and a median progression-free survival of...
As reported in The New England Journal of Medicine by Javier Cortés, MD, PhD, of the International Breast Cancer Center, Barcelona, and colleagues, the phase III DESTINY-Breast03 trial has shown significantly prolonged progression-free survival with fam-trastuzumab deruxtecan-nxki (T-DXd) vs...
The final overall survival analysis of the phase III PALOMA-2 trial has shown no significant benefit for palbociclib given with letrozole, vs letrozole and placebo, as a first-line treatment in hormone receptor–positive, HER2-negative metastatic breast cancer.1 The results were reported at the 2022 ...
For advanced breast cancer that is hormone receptor–positive and HER2-negative, sacituzumab govitecan-hziy significantly reduced the risk of disease progression by 34% over physician’s choice of treatment, based on the results of the phase III TROPiCS-02 trial.1 The heavily pretreated patients in...
In an updated analysis of the phase III MONALEESA-3 trial, which included postmenopausal patients with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer, first-line treatment with ribociclib plus fulvestrant added nearly 16 months of overall survival time vs fulvestrant...
Further analyses of the MONALEESA metastatic breast cancer trials have shown that the benefit of ribociclib plus endocrine therapy in the first-line setting extends to most intrinsic molecular subtypes and is consistent across multiple subgroups. The studies were presented at the 2021 San Antonio...