A5047768231- Advanced Breast Cancer Therapies
- HER2/EGFR in Cancer Research
- Cancer-related Molecular Pathways
- Lung Cancer Research Studies
- Cancer Treatment and Pharmacology
- Lung Cancer Treatments and Mutations
- Cancer Genomics and Diagnostics
- Breast Cancer Treatment Studies
- Neuroendocrine Tumor Research Advances
- Chronic Lymphocytic Leukemia Research
- Colorectal Cancer Treatments and Studies
- Opioid Use Disorder Treatment
- Pain Management and Opioid Use
- Cancer therapeutics and mechanisms
- Estrogen and related hormone effects
- Respiratory and Cough-Related Research
- BRCA gene mutations in cancer
- Male Breast Health Studies
- Stuttering Research and Treatment
- Phenothiazines and Benzothiazines Synthesis and Activities
- Bipolar Disorder and Treatment
- Single-cell and spatial transcriptomics
- Hepatocellular Carcinoma Treatment and Prognosis
- Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Pharmacological Effects and Assays
AstraZeneca (United States)
2021-2023
Pfizer (United States)
2012-2021
Vale (Canada)
2016-2020
Centre Eugène Marquis
2018
Osaka National Hospital
2017
Chiba Cancer Center
2017
National Hospital Organization
2017
Saitama Cancer Center
2017
Aichi Cancer Center
2017
Institute of Cancer Research
2016
Growth of hormone-receptor-positive breast cancer is dependent on cyclin-dependent kinases 4 and 6 (CDK4 CDK6), which promote progression from the G1 phase to S cell cycle. We assessed efficacy palbociclib (an inhibitor CDK4 CDK6) fulvestrant in advanced cancer.This 3 study involved 521 patients with hormone-receptor-positive, human epidermal growth factor receptor 2-negative that had relapsed or progressed during prior endocrine therapy. randomly assigned a 2:1 ratio receive placebo...
The cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor palbociclib, in combination with fulvestrant therapy, prolongs progression-free survival among patients hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. We report the results of a prespecified analysis overall survival. randomly assigned HER2-negative cancer who had progression or relapse during previous endocrine therapy to receive palbociclib plus placebo fulvestrant. analyzed...
ESR1 mutations are selected by prior aromatase inhibitor (AI) therapy in advanced breast cancer. We assessed the impact of on sensitivity to standard therapies two phase III randomized trials that represent development current for estrogen receptor-positive cancer.In a prospective-retrospective analysis, we available archived baseline plasma from SoFEA (Study Faslodex Versus Exemestane With or Without Arimidex) trial, which compared exemestane with fulvestrant-containing regimens patients...
CDK4/6 inhibition with endocrine therapy is now a standard of care for advanced estrogen receptor-positive breast cancer. Mechanisms inhibitor resistance have been described preclinically, limited evidence from clinical samples. We conducted paired baseline and end-of-treatment circulating tumor DNA sequencing 195 patients in the PALOMA-3 randomized phase III trial palbociclib plus fulvestrant versus placebo fulvestrant. show that clonal evolution occurs frequently during treatment,...
Abstract CDK4/6 inhibition substantially improves progression-free survival (PFS) for women with advanced estrogen receptor-positive breast cancer, although there are no predictive biomarkers. Early changes in circulating tumor DNA (ctDNA) level may provide early response prediction, but the impact of heterogeneity is unknown. Here we use plasma samples from patients randomized phase III PALOMA-3 study inhibitor palbociclib and fulvestrant cancer show that relative change PIK3CA ctDNA after...
A large-panel gene expression analysis was conducted to identify biomarkers associated with the effectiveness of adding palbociclib fulvestrant.The PALOMA-3 ( ClinicalTrials.gov identifier: NCT01942135) trial randomly assigned 521 endocrine-pretreated patients metastatic breast cancer receive plus fulvestrant or placebo fulvestrant. Primary first on 10 genes basis pathway biology and evidence from previous studies followed by a systematic panel-wide search among 2,534 cancer-related genes....
In the initial PALOMA-2 (NCT01740427) analysis with median follow-up of 23 months, palbociclib plus letrozole significantly prolonged progression-free survival (PFS) in women estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (ABC) [hazard ratio (HR) 0.58; P < 0.001]. Herein, we report results overall and by subgroups extended follow-up. this double-blind, phase 3 study, post-menopausal ER+/HER2− ABC who had not received prior...
Abstract Purpose: Cyclin-dependent kinase (CDK) 4/6 drives cell proliferation in estrogen receptor–positive (ER+) breast cancer. This single-arm phase II neoadjuvant trial (NeoPalAna) assessed the antiproliferative activity of CDK4/6 inhibitor palbociclib primary cancer as a prelude to adjuvant studies. Experimental Design: Eligible patients with clinical stage II/III ER+/HER2− received anastrozole 1 mg daily for 4 weeks (cycle 0; goserelin if premenopausal), followed by adding (125 on days...
Abstract Background. Palbociclib enhances endocrine therapy and improves clinical outcomes in hormone receptor (HR)-positive/human epidermal growth factor 2 (HER2)-negative metastatic breast cancer (MBC). Because this is a new target, it clinically important to understand palbociclib’s safety profile effectively manage toxicity optimize benefit. Materials Methods. Patients with endocrine-resistant, HR-positive/HER2-negative MBC (n = 521) were randomly assigned 2:1 receive fulvestrant (500 mg...
PURPOSE CDK4/6 inhibitors are used to treat estrogen receptor (ER)–positive metastatic breast cancer (BC) in combination with endocrine therapy. PALLET is a phase II randomized trial that evaluated the effects of palbociclib plus letrozole as neoadjuvant PATIENTS AND METHODS Postmenopausal women ER-positive primary BC and tumors greater than or equal 2.0 cm were randomly assigned 3:2:2:2 (2.5 mg/d) for 14 weeks (A); 2 weeks, then (B); (C); weeks. Palbociclib 125 mg/d was administered orally...
Palbociclib is an oral small-molecule inhibitor of cyclin-dependent kinases 4 and 6. In the randomized, open-label, phase II PALOMA-1/TRIO-18 trial, palbociclib in combination with letrozole improved progression-free survival (PFS) compared alone as first-line treatment estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative, advanced breast cancer (20.2 months versus 10.2 months; hazard ratio (HR) = 0.488, 95 % confidence interval (CI) 0.319–0.748; one-sided p...
In the PALOMA-3 study, palbociclib plus fulvestrant demonstrated improved progression-free survival compared with placebo in hormone receptor-positive, HER2- endocrine-resistant metastatic breast cancer (MBC). This analysis patient-reported outcomes (PROs) between two treatment groups.Patients were randomized 2 : 1 to receive 125 mg/day orally for 3 weeks followed by week off (n = 347) (500 mg i.m. per standard of care) or 174). PROs assessed on day cycles 1-4 and every other subsequent...
<h2>Abstract</h2><h3>Background</h3> Patient-reported outcomes are integral in benefit–risk assessments of new treatment regimens. The PALOMA-2 study provides the largest body evidence for patient-reported health-related quality life (QOL) patients with metastatic breast cancer (MBC) receiving first-line endocrine-based therapy (palbociclib plus letrozole and alone). <h3>Patients methods</h3> Treatment-naïve postmenopausal women estrogen receptor-positive (ER+)/human epidermal growth factor...
Abstract Background The efficacy and safety of palbociclib, a cyclin-dependent kinase 4/6 inhibitor, combined with fulvestrant goserelin was assessed in premenopausal women advanced breast cancer (ABC) who had progressed on prior endocrine therapy (ET). Patients Methods One hundred eight endocrine-refractory ≥18 years hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2−) ABC were among 521 randomized 2:1 (347:174) to (500 mg) ± either palbociclib (125...
To assess efficacy and safety of palbociclib plus fulvestrant in Asians with endocrine therapy-resistant metastatic breast cancer.The Palbociclib Ongoing Trials the Management Breast Cancer 3 (PALOMA-3) trial, a double-blind phase III study, included 521 patients hormone receptor-positive/human epidermal growth factor receptor 2-negative cancer disease progression on therapy. Patient-reported outcomes (PROs) were assessed study treatment at end treatment.This preplanned subgroup analysis...
Palbociclib plus endocrine therapy (ET) is the standard treatment of hormone receptor-positive and human epidermal growth factor receptor 2-negative, metastatic breast cancer (MBC). However, its efficacy has not been compared with that chemotherapy in a phase III trial.PEARL multicentre, randomised study which patients aromatase inhibitor (AI)-resistant MBC were included two consecutive cohorts. In cohort 1, 1 : to palbociclib exemestane or capecitabine. On discovering new evidence about...
Abstract Background There are no established molecular biomarkers for patients with breast cancer receiving combination endocrine and CDK4/6 inhibitor (CDK4/6i). We aimed to determine whether genomic markers in circulating tumor DNA (ctDNA) can identify at higher risk of early progression on fulvestrant therapy or without palbociclib, a CDK4/6i. Methods PALOMA-3 was phase III, multicenter, double-blind randomized controlled trial palbociclib plus (n = 347) vs placebo 174)...
Circulating tumor DNA (ctDNA) assays are increasingly used for clinical decision-making, but it is unknown how well different agree. We aimed to assess the agreement in ctDNA mutation calling between BEAMing (beads, emulsion, amplification, and magnetics) droplet digital PCR (ddPCR), 2 of most commonly techniques detecting mutations ctDNA.Baseline plasma samples from patients with advanced breast cancer enrolled phase 3 PALOMA-3 trial were assessed ESR1 PIK3CA both ddPCR. Concordance...
ESR1 mutation (ESR1m) is a frequent cause of acquired resistance to aromatase inhibitor (AI) plus cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i), which first-line therapy for hormone-receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). Camizestrant next-generation oral selective estrogen degrader (SERD) that in phase II study significantly improved progression-free survival (PFS) over fulvestrant (also SERD) ER+/HER2- ABC....