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Faslodex (Fulvestrant) - Summary



FASLODEX® (fulvestrant) Injection for intramuscular administration is an estrogen receptor antagonist without known agonist effects. The chemical name is 7-alpha-[9-(4,4,5,5,5-penta fluoropentylsulphinyl) nonyl]estra-1,3,5-(10)- triene-3,17-beta-diol.

FASLODEX is indicated for the treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.
See all Faslodex indications & dosage >>


Media Articles Related to Faslodex (Fulvestrant)

Identifying Potential Long-term Breast Cancer Survivors
Source: Medscape General Surgery Headlines [2016.07.22]
Which patients may be candidates for intensive breast cancer therapy? This new tool can help you decide.
Annals of Oncology

Uncovering a new principle in chemotherapy resistance in breast cancer
Source: Breast Cancer News From Medical News Today [2016.07.22]
A laboratory study has revealed an entirely unexpected process for acquiring drug resistance that bypasses the need to re-establish DNA damage repair in breast cancers that have mutant BRCA1 or...

IVF treatment not associated with increased risk of breast cancer
Source: Breast Cancer News From Medical News Today [2016.07.20]
Among women undergoing fertility treatment in the Netherlands between 1980 and 1995, the use of in vitro fertilization (IVF) compared with non-IVF treatment was not associated with increased risk...

A high-fat Mediterranean diet may protect against breast cancer, diabetes, and cardiovascular events
Source: Breast Cancer News From Medical News Today [2016.07.19]
According to researchers, a healthy diet can include "a lot of fat." A review of available evidence suggests that a Mediterranean diet with no restrictions on fat intake may reduce a person's risk...

No Breast Cancer Risk Seen With IVF (CME/CE)
Source: MedPage Today Endocrinology [2016.07.19]
(MedPage Today) -- Dutch study finds protective effect in some instances

more news >>

Published Studies Related to Faslodex (Fulvestrant)

Endocrine therapy with or without inhibition of epidermal growth factor receptor and human epidermal growth factor receptor 2: a randomized, double-blind, placebo-controlled phase III trial of fulvestrant with or without lapatinib for postmenopausal women with hormone receptor-positive advanced breast cancer-CALGB 40302 (Alliance). [2014]
metastatic breast cancer treated with fulvestrant... CONCLUSION: Adding lapatinib to fulvestrant does not improve PFS or OS in

Ganitumab with either exemestane or fulvestrant for postmenopausal women with advanced, hormone-receptor-positive breast cancer: a randomised, controlled, double-blind, phase 2 trial. [2013]
hormone-receptor-positive breast cancer... INTERPRETATION: Addition of ganitumab to endocrine treatment in women with

Fulvestrant 250 mg versus anastrozole for Chinese patients with advanced breast cancer: results of a multicentre, double-blind, randomised phase III trial. [2011.01]
BACKGROUND AND PURPOSE: Fulvestrant, an oestrogen receptor (ER) antagonist with no known agonist effects, has shown activity in postmenopausal patients with ER-positive advanced breast cancer recurring or progressing following prior endocrine therapy. This double-blind, double-dummy, randomised phase III study (NCT00327769) was designed to compare the efficacy and safety of fulvestrant versus anastrozole in advanced breast cancer of Chinese postmenopausal women whose disease has progressed following prior endocrine treatment... CONCLUSIONS: These data demonstrate that fulvestrant 250 mg and anastrozole were similarly effective and well tolerated in the treatment of postmenopausal Chinese women with advanced breast cancer whose disease had progressed or recurred on prior endocrine treatment.

Fulvestrant 250 mg versus anastrozole for Chinese patients with advanced breast cancer: results of a multicentre, double-blind, randomised phase III trial. [2011]
whose disease has progressed following prior endocrine treatment... CONCLUSIONS: These data demonstrate that fulvestrant 250 mg and anastrozole were

Three dose regimens of fulvestrant in postmenopausal Japanese women with advanced breast cancer: results from a double-blind, phase II comparative study (FINDER1). [2010.12]
BACKGROUND: FINDER1 compared efficacy, tolerability and pharmacokinetics (PK) of three fulvestrant dose regimens in postmenopausal Japanese women with estrogen receptor (ER)-positive locally advanced/metastatic breast cancer recurring or progressing after prior endocrine therapy... CONCLUSION: Fulvestrant AD, LD and HD had similar efficacy and tolerability profiles in postmenopausal Japanese women with ER-positive advanced breast cancer.

more studies >>

Clinical Trials Related to Faslodex (Fulvestrant)

Arimidex With or Without Faslodex In Postmenopausal Women With HR Positive Breast Cancer [Active, not recruiting]
Over the last 3 decades, a steady shift has occurred in the management of breast cancer. Because it was traditionally viewed as a local disease, many advocated the use of radical surgery to achieve maximum survival benefit. This view has been slowly replaced by a broader biologic view that recognizes the often systemic nature of breast cancer, even when it appears to be localized to the breast. Results from randomized clinical trials have demonstrated that less extensive surgery, or lumpectomy plus radiation therapy, are optimal for local management of early breast cancer. In addition to the less radical approach to surgical treatment of breast cancer, other randomized clinical trials have established the value of postoperative systemic therapy in improving overall survival by eradicating micrometastatic disease, the major cause of mortality from breast cancer. Despite the well-documented benefits of adjuvant systemic therapy, it is not effective in preventing death from breast cancer in all patients who are candidates for such treatment. The worth of such therapy can only be judged in retrospect upon disease relapse, a time when breast cancer is nearly always incurable. Currently, there are few reliable methods to predict the success or failure of a particular postoperative treatment modality, and better ways to predict and optimize outcome are needed. Combination endocrine therapy: Using endocrine agents with different mechanisms of action together has the potential advantage of more effectively blocking ER signaling, thus improving the efficacy of such agents against breast cancer. In the past, attempts to combine endocrine agents for ER-positive breast cancer have had mixed results, depending on the setting and the patient population studied. Endocrine agents without any agonist effect could potentially be used in combination with aromatase inhibitors, under the rationale that the combination would maximally blockade estrogen receptor signaling, thus potentially improving the antitumor effect. Fulvestrant (FASLODEX) is a pure estrogen antagonist with no known agonist effect; thus, it has the potential to provide additional benefit when combined with an aromatase inhibitor. This concept provides the rationale for using the combination of anastrazole and fulvestrant in this study.

Trial of ZD6474 and Faslodex in Non-Small Cell Lung Cancer [Withdrawn]
The purpose of this study is to evaluate the safety and tolerability of vandetanib and fulvestrant; to find the maximum tolerated dose of these two drugs; and to evaluate response rate and assess toxicity of this combination.

Study of Fulvestrant +/- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI [Recruiting]
Post-menopausal women with hormone-receptor positive (HR+) metastatic breast cancer resistant to aromatase inhibitor (AI) therapy will be randomized to receive Fulvestrant (Faslodex) with Everolimus or Fulvestrant (Faslodex) with a placebo (no active ingredients). Fulvestrant has demonstrated activity when used as first, second, or third line endocrine therapy, making it an attractive therapy for combination with other agents. In addition, it is commonly reserved for use following disease progression on AI therapy. Everolimus is an orally administered drug that blocks a signaling pathway called "mTOR". "mTOR" acts as a regulator for many processes in the body, including cell growth. Blocking this pathway may have an effect on cell growth. The combination of a novel class of agents (mTOR inhibitors) and an established standard treatment for metastatic HR+ breast cancer may potentially increase the clinical benefit by targeting multiple different biological pathways.

A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer. [Active, not recruiting]
The purpose of the study is to compare how treatment with Fulvestrant (FASLODEX) or Anastrozole (ARIMIDEX) effects disease progression for women with locally advanced or metastatic breast cancer who have not had prior hormonal treatment.

Anti-tumour Effects & Tolerability of Faslodex Alone or in Combination With Arimidex in Post Menopausal Women Prior to Surgery for Primary Breast Cancer [Completed]
To compare the anti-tumour effects as measured by changes in various biomarkers, of a combination of Faslodex and Arimidex with Faslodex alone and Arimidex alone in postmenopausal women patients with primary breast cancer who are awaiting curative-intent surgery.

more trials >>

Reports of Suspected Faslodex (Fulvestrant) Side Effects

Injection Site Pain (21)Fatigue (17)Back Pain (17)Dyspnoea (17)Pain (15)Nausea (15)Pain in Extremity (15)Arthralgia (15)Disease Progression (14)Hot Flush (13)more >>

Page last updated: 2016-07-22

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