FASLODEX SUMMARY
FASLODEX®
(fulvestrant)
INJECTION
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.
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NEWS HIGHLIGHTSMedia Articles Related to Faslodex (Fulvestrant)
Secretary Sebelius Statement On New Breast Cancer Recommendations
Source: Health News from Medical News Today [2009.11.19]
HHS Secretary Kathleen Sebelius issued the following statement today on new breast cancer screening recommendations from the U.S. Preventive Services Task Force: "There is no question that the U.S. Preventive Services Task Force Recommendations have caused a great deal of confusion and worry among women and their families across this country. I want to address that confusion head on. The U.S.
Breast Cancer Campaign: New Breast Cancer Research Funding For Belfast
Source: Health News from Medical News Today [2009.11.19]
Individualised radiotherapy treatment based on a person's genetic make up could soon become a reality, according to Breast Cancer Campaign. Professor Kevin Prise from Queen's University Belfast has been awarded a three year project grant by the charity to study how genes are involved in the effectiveness of radiotherapy treatment for breast cancer.
Some Physicians Say New Breast Cancer Screening Guidelines Unlikely To Alter Their Practices
Source: Health News from Medical News Today [2009.11.19]
One day after the release of new breast cancer screening guidelines, many physicians and some medical groups are saying that they do not plan to adopt the new recommendations -- which represent a drastic change -- the New York Times reports (Belluck, New York Times, 11/18). The guidelines, released by the U.S.
Radiation Breakthrough Gives Breast Cancer Patients Hope In Single Dose
Source: Breast Cancer News From Medical News Today [2009.11.19]
A radiation breakthrough to treat breast cancer patients in one day, as opposed to the current average of six weeks, has arrived at Cancer Treatment Centers of America(R) (CTCA) in Philadelphia. CTCA will become the first in the country to offer this treatment option using the Novac7 technology from Rome, Italy.
Breast Cancer Screening: New Fuel for an Old War of Words and Data
Source: MedPageToday.com - medical news plus CME for physicians [2009.11.19]
A controversy that has alternately simmered and boiled for more than 40 years reached a flash point this week when the U.S. Preventive Services Task Force published recommendations for breast cancer screening with mammography.
Published Studies Related to Faslodex (Fulvestrant)
Pharmacokinetic profile of the fulvestrant loading dose regimen in postmenopausal women with hormone receptor-positive advanced breast cancer. [2008.08]
PURPOSE: Fulvestrant is at least as effective as anastrozole in the treatment of postmenopausal women with advanced breast cancer whose disease has previously progressed or recurred on antiestrogen therapy. Pharmacokinetic data have shown that, at the approved dose (250 mg/month), it takes approximately 3-6 months for fulvestrant to reach steady-state levels. Theoretically, a more rapid attainment of steady state might reduce the number of early progressions. A pharmacokinetic model simulating plasma concentrations expected to be achieved with a fulvestrant loading dose (LD) regimen suggested that steady state might be achieved earlier with the LD. The aim of this study was to characterize the pharmacokinetics of the fulvestrant LD regimen. This pharmacokinetic substudy was conducted within a phase III trial, EFECT (Evaluation of Fulvestrant versus Exemestane Clinical Trial), comparing fulvestrant with exemestane in postmenopausal women with hormone-sensitive advanced breast cancer whose disease had progressed or recurred following nonsteroidal aromatase inhibitor treatment... CONCLUSION: Steady-state plasma levels were attained within the first month of treatment with fulvestrant LD, in line with the predictions of the pharmacokinetic model.
Double-blind, randomized placebo controlled trial of fulvestrant compared with exemestane after prior nonsteroidal aromatase inhibitor therapy in postmenopausal women with hormone receptor-positive, advanced breast cancer: results from EFECT. [2008.04.01]
PURPOSE: The third-generation nonsteroidal aromatase inhibitors (AIs) are increasingly used as adjuvant and first-line advanced therapy for postmenopausal, hormone receptor-positive (HR+) breast cancer. Because many patients subsequently experience progression or relapse, it is important to identify agents with efficacy after AI failure... CONCLUSION: Fulvestrant LD and exemestane are equally active and well-tolerated in a meaningful proportion of postmenopausal women with ABC who have experienced progression or recurrence during treatment with a nonsteroidal AI.
Double-Blind, Randomized Placebo Controlled Trial of Fulvestrant Compared With Exemestane After Prior Nonsteroidal Aromatase Inhibitor Therapy in Postmenopausal Women With Hormone Receptor-Positive, Advanced Breast Cancer: Results From EFECT. [2008.03.03]
CONCLUSION: Fulvestrant LD and exemestane are equally active and well-tolerated in a meaningful proportion of postmenopausal women with ABC who have experienced progression or recurrence during treatment with a nonsteroidal AI.
Fulvestrant: pharmacologic profile versus existing endocrine agents for the treatment of breast cancer. [2006.09]
CONCLUSIONS: Fulvestrant appears to have little effect on sex hormone endocrinology, bone metabolism, and lipid biochemistry and is unlikely to be subject to or the cause of CYP3A4-mediated drug-drug interactions. As such, fulvestrant represents a valuable new endocrine therapy for the treatment of ABC and broadens the options available to clinicians in the treatment of this disease.
Endocrine response after prior treatment with fulvestrant in postmenopausal women with advanced breast cancer: experience from a single centre. [2006.03]
The pure anti-oestrogen fulvestrant has now been licensed for use in advanced breast cancer which has progressed on an anti-oestrogen... It would thus appear that further endocrine response can be induced in a reasonable proportion of patients after failing fulvestrant.
Clinical Trials Related to Faslodex (Fulvestrant)
Fulvestrant (FASLODEX™) as a Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer [Completed]
The purpose of this study is to evaluate fulvestrant in the preliminary stage of breast
cancer treatment and assess the relationship between dose, exposure, degree of reduction in
tumor markers, and efficacy in postmenopausal women with estrogen receptor positive disease.
Comparison of Fulvestrant (FASLODEX™) 250 mg and 500mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy. [Active, not recruiting]
The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant
with the standard dose of 250 mg in postmenopausal women with estrogen receptor positive
advanced breast cancer who have failed on a previous endocrine treatment.
Faslodex and Herceptin, Alone and Combined [Recruiting]
The purpose of this study is to evaluate the the relative anti-tumor efficacy of combined Faslodex and Herceptin therapy as compared with that of Faslodex or Herceptin given alone for first-line treatment in patients with metastatic breast cancer.
The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer [Active, not recruiting]
The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Aromasin
(exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer.
Patients will be treated until disease progression or until the investigator has determined
that treatment is not in the best interest of the patient, whichever occurs first.
Arimidex/Faslodex/Iressa Study: A Trial Using Arimidex, Faslodex and Iressa in Women With Breast Cancer [Active, not recruiting]
The investigators want to know if combining Arimidex and Faslodex with Iressa will be an
effective treatment for breast cancer. They also want to know, using special tests on the
tumor, the changes that occur with the treatment so they can try to improve their treatment
for breast cancer in the future.
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