Using the EQ-5D Health Index during the course of treatment, this study compares patient-reported general health status during treatment with palbociclib (a cyclin-dependent kinase 4/6 inhibitor) plus fulvestrant (a complete estrogen receptor antagonist) compared with during treatment with fulvestrant alone.
Exploring the Relationship Between Progression-Free Survival and Overall Survival in Breast Cancer Patients Treated with Fulvestrant or Anastrozole
Progression-free survival (PFS) is often used as a surrogate for overall survival (OS) due to the challenges of measuring OS in relatively short-term trials, and is a practice that has been supported by previous analyses of breast cancer data. This analysis further examines the relationship between PFS and OS in advanced breast cancer.
Eribulin mesylate is an inhibitor of microtubule dynamics that may play a role in reducing the abnormality of the tumor microenvironment (ie, increasing oxygenation). As hypoxic conditions may contribute to drug resistance, it is hypothesized that eribulin may enhance the efficacy of other therapies. In this study, the effects of eribulin on 2 endocrine therapies were evaluated.
In a retrospective study of 45 breast cancer patients, the differential expression of estrogen receptor, progesterone receptor, human epidermal growth factor receptor 2, and Ki-67 is evaluated in primary and relapsed tumors. The conversion rate of these biomarkers and their prognostic relevance are assessed.
Exploratory Biomarkers in MONARCH 1: A Phase 2 Study of Abemaciclib Monotherapy in HR+/HER2– Metastatic Breast Cancer
In this study, patients with advanced hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2–) breast cancer that have disease progression following antiestrogen therapy are treated with abemaciclib (a selective inhibitor of cyclin-dependent kinases 4 and 6) as a monotherapy. Exploratory biomarkers identified during this study are presented.
Next-Generation Sequencing Reveals Molecular Subtypes Beyond Those Defined by Hormone Receptor Expression
Breast carcinomas can be classified into 4 subtypes based on their hormone receptor expression: basal, luminal A, luminal B, and human epidermal growth factor receptor 2 overexpressed. This study uses comprehensive genomic profiling to further stratify tumors by their predicted sensitivity to a variety of therapies.
Everolimus, an inhibitor of mammalian target of rapamycin, is approved for use in the United States and European Union in combination with exemestane (an aromatase inhibitor) for the treatment of postmenopausal women with advanced estrogen receptor–positive/human epidermal growth factor receptor 2–negative breast cancer. This retrospective study evaluates the patterns of care and complications associated with this treatment over a 5-year period (2009-2014).
Circulating Tumor Cell Counts May Have Prognostic Value in Determining First-Line Therapy in HR+/HER2– Metastatic Breast Cancer
In patients with hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2–) metastatic breast cancer, the decision to treat first with hormone therapy or chemotherapy can be made at the discretion of the attending oncologist, or by taking into account the number of circulating tumor cells. This phase 3 study compares the outcome of these 2 methods.
Preliminary Safety and Efficacy of TAK-228 plus Exemestane or Fulvestrant in ER+/HER2– Metastatic Breast Cancer
TAK-228 is an investigational, oral, highly selective, ATP-competitive inhibitor of TORC1/2. By mitigating feedback within the PI3K/AKT/mTOR pathway, TAK-228 may restore sensitivity to endocrine therapies in patients who have progressed on such agents in combination with everolimus. This phase 1b/2 study evaluates the safety, pharmacokinetics, and preliminary efficacy of TAK-228 in combination with exemestane or fulvestrant.
Fulvestrant (a complete estrogen receptor [ER] antagonist) represents an endocrine therapy for patients with ER-positive metastatic breast cancer who have disease progression after treatment with an antiestrogen. This study evaluates the clinical benefit rate of fulvestrant 500 mg monthly, defined as complete response, partial response, or stable disease lasting >24 weeks, in women with locally advanced breast cancer.
The objective of this study is to evaluate the efficacy and safety of everolimus (an inhibitor of mammalian target of rapamycin) in combination with letrozole (an aromatase inhibitor) in postmenopausal women with advanced estrogen receptor–positive (ER+)/human epidermal growth factor receptor 2–negative (HER2–) breast cancer.
PM01183 (lurbinectedin) is an investigational compound that blocks transactivated transcription and induces the formation of double-strand breaks in a range of cancer lines. This study is designed to evaluate whether the presence of BRCA1/2 mutations can act as a prognostic indicator of response to PM01183 in patients with metastatic breast cancer.
This study is designed to compare treatment with palbociclib (a cyclin-dependent kinase 4/6 inhibitor) in combination with letrozole (an aromatase inhibitor) versus placebo with letrozole in postmenopausal women with estrogen receptor–positive (ER+)/human epidermal growth factor receptor 2–negative (HER2–) advanced breast cancer. A secondary outcome measure of the study, the analysis of tumor tissue biomarkers, is presented here.
Fulvestrant is a complete estrogen receptor (ER) antagonist currently approved for the treatment of ER-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy. This phase 3 study compares first-line fulvestrant with anastrozole (an aromatase inhibitor) in postmenopausal women with ER-positive and/or progesterone receptor–positive advanced breast cancer.
The French SIGNAL and PHARE projects have collected data on more than 9800 patients with breast cancer since 2006. In evaluating the outcomes of sequential and concomitant administration of trastuzumab within this cohort, this study provides insight into the ideal administration protocol for patients with human epidermal growth factor receptor 2–positive (HER2+) breast cancer.
The 21-gene Recurrence Score® is the result of a commercial genomic test that evaluates the likelihood that breast cancer will recur, and the likely benefit from chemotherapy and/or radiation therapy. This study evaluates disparities in hormone receptor–positive (HR+) breast cancer outcome by age and 21-gene Recurrence Score®.
Previous studies have reported that an elevated neutrophil-to-lymphocyte ratio is associated with an increased risk of relapse and worse survival in women with breast cancer. Additional data about the prognostic role for this biomarker in patients with early breast cancer are presented here.
In this ongoing phase 2 study, postmenopausal women with hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2–) breast cancer are being treated with abemaciclib (a selective inhibitor of cyclin-dependent kinases 4 and 6), anastrozole (an aromatase inhibitor), or both simultaneously.
Results from an open-label, randomized phase 3 trial evaluating the effects of panitumumab plus best supportive care versus best supportive care alone in chemorefractory, wild-type KRAS exon 2 and wild-type RAS metastatic colorectal cancer.
Results from a phase 1b study of the cancer stem-cell pathway inhibitor BBI608 in combination with FOLFIRI ± bevacizumab in patients with advanced colorectal cancer.
NEO-102, an Anti-MUC5AC Monoclonal Antibody, in Chemotherapy-Refractory Metastatic Colorectal Cancer
Initial results from a phase 2 open-label study of NEO-102, a novel chimeric monoclonal antibody targeting a variant of MUC5AC, in patients with chemotherapy-refractory metastatic colorectal cancer.
Results from STEAM, an open-label, randomized, phase 2 study of sequential versus concurrent FOLFOXIRI plus bevacizumab as first-line treatment of patients with metastatic colorectal cancer.
Results from the phase 1b JAVELIN study of the anti–PD-L1 monoclonal antibody avelumab in patients with advanced gastric or gastroesophageal junction cancer, stratified based on the level of PD-L1 expression.
Results of an open-label phase 1/2 study evaluating the safety and efficacy of nivolumab monotherapy for patients with advanced gastroesophageal or gastric cancer.
Results of the phase 1b KEYNOTE-028 study of pembrolizumab in PD-L1+ advanced esophageal carcinoma.
Investigation of the role of the mTOR pathway on the stemness of a putative cancer stem- cell population in esophageal cancer.
Ramucirumab Plus Paclitaxel in Previously Treated Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Results from RAINBOW, a randomized phase 3 trial of the safety and efficacy of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastroesophageal junction adenocarcinoma.
An in vitro study to determine whether inactivation of the Notch and wnt-beta-catenin pathways is crucial for cancer stem-cell development and if such a therapeutic approach with a γ-secretase inhibitor would be effective in treating patients with gastric cancer.
Results from a phase 1b study of the anticancer stem-cell agent demcizumab plus gemcitabine with or without nab-paclitaxel in the first-line treatment of patients with pancreatic cancer.
Results from a phase 1b study of the cancer stem-cell pathway inhibitor BBI608 plus gemcitabine and nab-paclitaxel in treating patients with metastatic pancreatic ductal adenocarcinoma.
Results of a clinical trial to determine if transcatheter chemoembolization, radiofrequency ablation, and cryoablation can enhance the effect of the CTLA-4 inhibitor tremelimumab in treating patients with hepatocellular carcinoma or biliary tract carcinoma.
Safety and efficacy results of a phase 2 trial assessing outcomes of patients with resected pancreatic adenocarcinoma treated with gemcitabine plus cisplatin and stratified by tumor excision repair cross-complementing gene-1 (ERCC1).
Results of a phase 1b/2 study of the safety and efficacy of the cancer stem-cell inhibitor BBI608 plus paclitaxel in treating patients with advanced pancreatic cancer.