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Fulvestrant (By injection)

What works?

Learn more about the effects of these drugs. The most reliable research is summed up for you in our featured article.

Fulvestrant injection is used to treat hormone-receptor (HR) positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women who have not been treated previously with other medicines. It is also used in combination with palbociclib or abemaciclib to treat HR positive, HER2-negative advanced or metastatic (cancer that has spread) breast cancer in… Read more
Brand names include
Faslodex
Drug classes About this
Antiestrogen

What works? Research summarized

Evidence reviews

Fulvestrant in the treatment of postmenopausal women with advanced hormone‐sensitive breast cancer

We reviewed the evidence concerning the effectiveness and safety of fulvestrant in prolonging time without further progression of cancer in women with advanced hormone‐sensitive breast cancer. We found nine studies testing whether or not fulvestrant is superior to other treatment options.

A meta-analysis of anastrozole in combination with fulvestrant in the first line treatment of hormone receptor positive advanced breast cancer

Fulvestrant is a highly active systemic therapy in patients with metastatic hormone receptor positive breast cancer. Preclinical work suggested potential synergy of fulvestrant in combination with aromatase inhibitor therapy and delayed development of endocrine resistance. The purpose of this meta-analysis is to evaluate the effectiveness of fulvestrant plus anastrozole, compared to anastrozole alone, as first line treatment of postmenopausal stage IV hormone receptor positive, HER2-negative breast cancer. The literature search was performed using PubMed, Google Scholar, Embase, ASCO, and ESMO to search for abstracts published during the last 10 years using relevant keywords. Two prospective randomized clinical trials were found to fulfill the search criteria for combination of anastrozole plus fulvestrant versus anastrozole alone. Meta-estimates were calculated by combining study estimates using the DerSimonian and Laird random effects model. The linear mixed-effects model was used to generate 95 % prediction intervals (PIs) for study-specific hazard and odds ratios. Pooled hazard ratio for progression-free survival is 0.88 (95 % CI 0.72-1.09, 95 % PI 0.65-1.21), overall survival 0.88 (95 % CI 0.72-1.08, 95 % PI 0.68-1.14) and pooled odds ratio for response rate is 1.13 (95 % CI 0.79-1.63, 95 % PI 0.78-1.65). A non-significant trend was observed with anastrozole plus fulvestrant being only marginally better than anastrozole alone in the endpoints of: progression-free survival, overall survival, and response rates. Based on these data, there is not solid evidence that the addition of fulvestrant at a dose of 250 mg monthly is better than anastrozole alone as first line therapy in women with postmenopausal hormone receptor positive breast cancer.

Comparative efficacy of everolimus plus exemestane versus fulvestrant for hormone-receptor-positive advanced breast cancer following progression/recurrence after endocrine therapy: a network meta-analysis

Postmenopausal women with advanced breast cancer recurring/progressing on or after initial (adjuvant or first-line) endocrine therapy may be treated multiple times with one of several endocrine or combinatorial targeted treatment options before initiating chemotherapy. In the absence of direct head-to-head comparisons of these treatment options, an indirect comparison can inform treatment choice. This network meta-analysis compared the efficacy of everolimus plus exemestane with that of fulvestrant 250 and 500 mg in the advanced breast cancer setting following adjuvant or first-line endocrine therapy. The reported hazard ratios (HRs) for progression-free survival (PFS) or time to progression from six studies that formed a network to compare everolimus plus exemestane (BOLERO-2 trial) with fulvestrant were analyzed by means of a Bayesian network meta-analysis. In the primary comparison (PFS analysis based on the local review of disease progression from BOLERO-2 with the data from the other studies), everolimus plus exemestane appeared to be more efficacious than both fulvestrant 250 mg (HR = 0.47; 95 % credible interval [CrI] 0.38-0.58) and 500 mg (HR = 0.59; 95 % CrI 0.45-0.77). Similar results were obtained in an alternate comparison based on central review of disease progression from BOLERO-2 with the data from the other studies (HR = 0.40; 95 % CrI 0.31-0.51 and HR = 0.50; 95 % CrI 0.37-0.67, respectively), and in a subgroup analysis of patients who had received prior aromatase inhibitor therapy (HR = 0.47; 95 % CrI 0.38-0.58 and HR = 0.55; 95 % CrI 0.40-0.76, respectively). These results suggest that everolimus plus exemestane may be more efficacious than fulvestrant in patients with advanced breast cancer who progress on or after adjuvant or first-line therapy with a nonsteroidal aromatase inhibitor.

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Summaries for consumers

Fulvestrant in the treatment of postmenopausal women with advanced hormone‐sensitive breast cancer

We reviewed the evidence concerning the effectiveness and safety of fulvestrant in prolonging time without further progression of cancer in women with advanced hormone‐sensitive breast cancer. We found nine studies testing whether or not fulvestrant is superior to other treatment options.

Palbociclib (Ibrance) for the treatment of advanced breast cancer: Overview

Palbociclib (trade name: Ibrance) has been approved in Germany since November 2016 for the treatment of advanced hormone-receptor-positive breast cancer in women. It is an option if a woman can't have any surgery, radiation therapy or chemotherapy that aims to cure the cancer.

Breast Cancer Treatment (PDQ®): Patient Version

Breast cancer treatment depends on several factors and can include combinations of surgery, chemotherapy, radiation, hormone, and targeted therapy. Learn more about how breast cancer is diagnosed and treated in this expert-reviewed summary.

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