Fulvestrant plus anastrozole or placebo versus exemestane alone after progression on non-steroidal aromatase inhibitors in postmenopausal patients with hormone-receptor-positive locally advanced or metastatic breast cancer (SoFEA): a composite, multicentre, phase 3 randomised trial

Johnston, Stephen; Kilburn, Lucy; Ellis, Paul; Dodwell, David; Cameron, David; Hayward, Larry; Im, Young‐Hyuck; Braybrooke, Jeremy; Brunt, Adrian Murray; Cheung, Kwok-Leung; Jyothirmayi, R.; Robinson, A.; Wardley, Andrew M; Wheatley, Duncan; Howell, Anthony; Coombes, Gill; Sergenson, Nicole; Sin, Hui-Jung; Folkerd, Elizabeth; Dowsett, Mitch; Bliss, Judith

doi:10.1016/s1470-2045(13)70322-x

Cited by 245 publications

(156 citation statements)

References 17 publications

Supporting

Mentioning

148

Contrasting

Unclassified

Order By: Relevance

“…In particular, in patients with hormone-sensitive tumors, endocrine therapy can provide survivals similar to those obtained with chemotherapy (although with fewer objective responses) and has to be considered as a first choice in the absence clinical evidence of aggressive disease (4)(5)(6)(7)(8). Nevertheless, prolonged exposure to endocrine therapy may result in acquired resistance and subsequent progression of disease.…”

Section: Introductionmentioning

confidence: 99%

Cell-Free DNA and Circulating Tumor Cells: Comprehensive Liquid Biopsy Analysis in Advanced Breast Cancer

Rossi

Rademaker

et al. 2018

Clinical Cancer Research

121

View full text Add to dashboard Cite

Purpose: Liquid biopsy provides a real-time assessment of metastatic breast cancer (MBC). We evaluated the utility of combining circulating tumor cells (CTC) and circulating tumor DNA (ctDNA) to predict prognosis in MBC.Experimental Design: We conducted a retrospective study of 91 patients with locally advanced breast cancer and MBC. CTCs were enumerated by CellSearch; the plasma-based assay was performed utilizing Guardant360 and the survival analysis using Kaplan-Meier curves.Results: Eighty-four patients had stage IV cancer, and 7 patients had no metastases. Eighty patients had CTC analysis: median number 2 (0-5,612). Blood samples [232 of 277 (84%)] had mutations. The average ctDNA fraction was 4.5% (0-88.2%) and number of alterations 3 (0-27); the most commonly mutated genes were TP53 (52%), PIK3CA (40%), and ERBB2 (20%). At the time of analysis, 36 patients (39.6%) were dead. The median follow-up for CTCs was 9 months; for ctDNA, it was 9.9 months. For CTCs and ctDNA, respectively, progression-free survival (PFS) was 4.2 and 5.2 months and overall survival (OS) was 18.7 and 21.5 months. There was a statistically significant difference in PFS and OS for baseline CTCs < 5 versus CTCs ! 5 (P ¼ 0.021 and P ¼ 0.0004, respectively); %ctDNA < 0.5 versus ! 0.5 (P ¼ 0.003 and P ¼ 0.012); number of alterations < 2 versus ! 2 (P ¼ 0.059 borderline and P ¼ 0.0015). A significant association by Fisher exact test was found between the number of alterations and the %ctDNA in the baseline sample (P < 0.0001).Conclusions: The study demonstrated that liquid biopsy is an effective prognostic tool. Clin Cancer Res; 24(3); 560-8. Ó2017 AACR.

show abstract

Section: Introductionmentioning

confidence: 99%

Cell-Free DNA and Circulating Tumor Cells: Comprehensive Liquid Biopsy Analysis in Advanced Breast Cancer

Rossi

Rademaker

et al. 2018

Clinical Cancer Research

121

View full text Add to dashboard Cite

show abstract

“…At the lower dose, no benefit was seen when fulvestrant was compared with ais. Furthermore, the combination of fulvestrant (250 mg monthly) with anastrozole did not show any advantage compared with fulvestrant (250 mg monthly) or an ai alone as second-line treatment, as seen in the phase iii sofea trial described in Table ii 39 .…”

Section: Fulvestrant As a Single Agent Or In Combination Withmentioning

confidence: 90%

Hormone Receptor–Positive, HER2-Negative Metastatic Breast Cancer: Redrawing the Lines

et al. 2018

View full text Add to dashboard Cite

Estrogen receptor modulators and estrogen deprivation have become standards of care for hormone receptorpositive metastatic breast cancer. However, after traditional first-line endocrine monotherapy treatment, the disease typically progresses despite the initial high rate of clinical benefit. Multiple studies have aimed at optimizing treatment strategies to improve upon clinical benefit beyond the traditional single-agent endocrine treatment. With the availability of new data and novel therapies, the clinical practice challenge becomes how best to define the optimal treatment sequence to maximize clinical benefit. In this review, we present treatment options clinically relevant to the management of hormone-positive, her2-negative metastatic breast cancer, and we propose a treatment algorithm based on the current literature.

show abstract

“…Combined analysis (Robertson et al 2003) indicated non-inferiority of fulvestrant in terms of the primary endpoint of time to progression (TTP). The SoFEA study compared fulvestrant (with or without anastrozole) with the steroidal AI 23:8 exemestane in patients with HR+ MBC and evidence of prior endocrine sensitivity in either the adjuvant or advanced setting (Johnston et al 2013). No difference in the primary endpoint of progression-free survival (PFS) was seen between the three arms.…”

Section: Fulvestrant Clinical Studiesmentioning

confidence: 99%

Endocrine resistance in hormone-responsive breast cancer: mechanisms and therapeutic strategies

Murphy¹,

Dickler²

2016

Endocrine-Related Cancer

105

View full text Add to dashboard Cite

The majority of breast cancers may be considered hormone responsive due to expression of hormone receptors (HR+). Although endocrine therapy is always considered for advanced HR+ breast cancer, the emergence of resistance is inevitable over time and is present from the start in a proportion of patients. In this review, we explore the mechanisms underlying de novo and acquired resistance to endocrine therapy. We comprehensively review newly approved and emerging therapies that have been developed to counteract specific mechanisms of resistance. We discuss the challenges pertinent to this therapeutic arena including the potential relief of negative regulatory feedback inhibition with compensatory pathway activation and the evolution of molecular changes in HR+ breast cancers during treatment. We discuss strategies to address these challenges in order to develop rational therapy approaches for patients with advanced HR+ breast cancer.

show abstract

Fulvestrant plus anastrozole or placebo versus exemestane alone after progression on non-steroidal aromatase inhibitors in postmenopausal patients with hormone-receptor-positive locally advanced or metastatic breast cancer (SoFEA): a composite, multicentre, phase 3 randomised trial

Abstract: After loss of response to NSAIs in postmenopausal women with hormone-receptor-positive advanced breast cancer, maximum double endocrine treatment with 250 mg fulvestrant combined with oestrogen deprivation is no better than either fulvestrant alone or exemestane.

Cited by 245 publications

References 17 publications

Cell-Free DNA and Circulating Tumor Cells: Comprehensive Liquid Biopsy Analysis in Advanced Breast Cancer

Cell-Free DNA and Circulating Tumor Cells: Comprehensive Liquid Biopsy Analysis in Advanced Breast Cancer

Hormone Receptor–Positive, HER2-Negative Metastatic Breast Cancer: Redrawing the Lines

Endocrine resistance in hormone-responsive breast cancer: mechanisms and therapeutic strategies

Contact Info

Product

Resources

About