Second-line fulvestrant

Two randomized trials that enrolled 400 and 451 patients whose disease had progressed after they received tamoxifen demonstrated that fulvestrant yielded results similar to those of anastrozole in terms of its impact on PFS.[42,43] The proper sequence of these therapies is not known.[44,45]

EFECT (NCT00065325) was a phase III, double-blind, randomized trial that compared fulvestrant given in a loading-dose regimen (500 mg day 0, 250 mg days 14 and 28, and 250 mg every 28 days thereafter) with exemestane (25 mg) in women who had developed progressive disease after previous nonsteroidal AI (anastrozole or letrozole) therapy.[46] The trial randomly assigned 351 women to receive fulvestrant and 342 women to receive exemestane.

EFECT (NCT00065325) was a phase III, double-blind, randomized trial that compared fulvestrant given in a loading-dose regimen (500 mg day 0, 250 mg days 14 and 28, and 250 mg every 28 days thereafter) with exemestane (25 mg) in women who had developed progressive disease after previous nonsteroidal AI (anastrozole or letrozole) therapy.[46] The trial randomly assigned 351 women to receive fulvestrant and 342 women to receive exemestane.

Median time to progression was 3.7 months in both groups (HR, 0.93; 95% CI, 0.819−1.133; P = .65).[46][Level of evidence B1]

EFECT (NCT00065325) was a phase III, double-blind, randomized trial that compared fulvestrant given in a loading-dose regimen (500 mg day 0, 250 mg days 14 and 28, and 250 mg every 28 days thereafter) with exemestane (25 mg) in women who had developed progressive disease after previous nonsteroidal AI (anastrozole or letrozole) therapy.[46] The trial randomly assigned 351 women to receive fulvestrant and 342 women to receive exemestane.

The frequency of adverse events was similar in both groups, and there was no difference in quality of life.

EFECT (NCT00065325) was a phase III, double-blind, randomized trial that compared fulvestrant given in a loading-dose regimen (500 mg day 0, 250 mg days 14 and 28, and 250 mg every 28 days thereafter) with exemestane (25 mg) in women who had developed progressive disease after previous nonsteroidal AI (anastrozole or letrozole) therapy.[46] The trial randomly assigned 351 women to receive fulvestrant and 342 women to receive exemestane.

OS results were not reported.

CONFIRM (NCT00099437) was a double-blind phase III trial that compared two doses of fulvestrant (500 mg vs. 250 mg, each given in a loading-dose schedule) in 736 women whose disease had progressed on previous endocrine therapy.[47]

CONFIRM (NCT00099437) was a double-blind phase III trial that compared two doses of fulvestrant (500 mg vs. 250 mg, each given in a loading-dose schedule) in 736 women whose disease had progressed on previous endocrine therapy.[47]

PFS was significantly better on the higher-dose arm (HR, 0.80; 95% CI, 0.68–0.94; P = .006).[47][Level of evidence B1]

CONFIRM (NCT00099437) was a double-blind phase III trial that compared two doses of fulvestrant (500 mg vs. 250 mg, each given in a loading-dose schedule) in 736 women whose disease had progressed on previous endocrine therapy.[47]

Adverse events and quality of life were similar on the two arms.