来曲唑与TP-来曲唑序贯方案治疗绝经后晚期乳腺癌

[目的]比较来曲唑与TP-来曲唑序贯联用两种方案治疗绝经后晚期乳腺癌的疗效和不良反应。[方法]47例晚期绝经后乳腺癌随机分为两组,A组23例接受来曲唑2.5mg,口服,每天1次,30天为1个周期;B组24例先接受TP方案(多西紫杉醇、顺铂)化疗2个疗程,继服来曲唑,方法同A组。[结果]两组有效率分别为39.1%和41.7%,临床获益率分别为69.6%和70.8%(P>0.05),在不同的受体状态、绝经情况、治疗阶段,两组疗效无差异(P>0.05),B组对内脏转移疗效高于A组(P<0.01);两组中位疾病进展时间(TTP)及中位缓解期分别为6.5个月vs.7.5个月和9.6个月vs.11.6个月(P>0.05)。两组主要不良反应为Ⅰ～Ⅱ级的消化道反应、骨髓抑制和乏力。[结论]单服来曲唑和TP-来曲唑序贯方案治疗绝经后晚期乳腺癌安全、疗效肯定,可作为一线方案。对伴内脏转移患者,首选TP-来曲唑序贯方案。     

来曲唑联合唑来磷酸治疗乳腺癌骨转移

目的:观察来曲唑联合唑来磷酸治疗乳腺癌骨转移的临床疗效及不良反应.方法:使用来曲唑联合唑来磷酸静脉注射治疗32例绝经后妇女乳腺癌骨转移伴有不同程度骨痛患者,观察其镇痛效果、骨转移灶的变化及不良反应.结果:32例患者接受治疗后,止痛的总有效率93.75%;骨转移灶有明显缩小,临床获益率90.62%;所有患者均未发现严重的不良反应.结论:来曲唑联合唑来磷酸对绝经后妇女乳腺癌骨转移骨痛的临床止痛疗效明显,对乳腺癌骨转移是一种有效的治疗方法.     

来曲唑联合唑来膦酸治疗绝经后乳腺癌骨转移疗效观察

目的:观察来曲唑联合唑来膦酸治疗绝经后乳腺癌骨转移的临床效果及不良反应.方法:42例绝经后乳腺癌骨转移患者给予来曲唑片口服 2.5mg/d,唑来膦酸4mg加入生理盐水100ml静滴,每4周1周期,两药连用3个周期后评价疗效.结果:治疗后止痛、体力状况的改善及骨转移病灶的有效率分别为85.71%、69.05%、45.24%,主要不良反应为发热.结论:来曲唑联合唑来膦酸治疗绝经后乳腺癌骨转移有较好的疗效,不良反应少,患者容易接受.     

来曲唑治疗绝经后晚期乳腺癌临床观察

目的观察来曲唑治疗绝经后晚期乳腺癌的疗效和不良反应。方法42例雌激素或孕激素受体阳性或不明的绝经后晚期乳腺癌患者口服来曲唑每日一次,每次2.5mg,28天一周期,至少2周期。结果42例患者中,可评价疗效者42例。完全缓解(CR)0例;部分缓解(PR)5例,占11.9%;稳定(SD)23例,占54.8%,其中SD≥6个月14例,占33.3%;临床获益CBR(CR PR SD≥6个月)19例,占45.2%;进展14例,占33.3%。肿瘤进展时间2月~58月,中位进展时间(TTP)10月。未出现严重不良反应。结论来曲唑治疗绝经后晚期乳腺癌疗效确切,不良反应轻微,耐受性好。     

阿仑膦酸钠预防来曲唑引起的绝经后早期乳腺癌患者骨量丢失的疗效

目的探讨阿仑膦酸钠预防来曲唑引起的绝经后早期乳腺癌患者骨量丢失的疗效。方法选择服用来曲唑的绝经后乳腺癌患者82例,随机分为2组。A组42例服用来曲唑,B组40例服用来曲唑的同时给予阿仑膦酸钠治疗。分别在服用来曲唑前及服药后6、12个月采用双能X线骨密度仪对82例绝经后乳腺癌患者进行骨密度(BMD)检测。结果 2组患者接受来曲唑治疗后6、12个月,BMD均出现下降;来曲唑治疗后12个月,A组较B组BMD下降更明显(P均<0.05)。结论来曲唑可加剧绝经后乳腺癌患者骨量丢失;应用阿仑膦酸钠可有效减轻患者的骨量丢失。     

来曲唑与氨鲁米特对照治疗绝经后晚期乳腺癌113例

目的对比来曲唑和氨鲁米特治疗妇女绝经后晚期乳腺癌患者的有效性和耐受性。方法采用开放、随机、多中心对照研究。患者随机分组接受口服来曲唑2.5mg.d~(-1)或氨鲁米特1g.d(-1)的对照治疗。结果来曲唑组(n=59)有效率23.73%(CR 2例,PR 12例,ITT 有效率21.88%),SD 20.31%(13例)。氨鲁米特组(n=54)有效率11.11%(CR 1例,PR 5例,ITT 有效率10.17%),SD 20.34%(12例),2组疗效无统计学差异(P>0.05)。来曲唑组和氨鲁米特组不良反应发生率分别为18.64%和42.11%,与治疗相关的不良反应发生率分别为13.56%和33.33%。比较2组总的和与治疗相关的不良反应发生率均以来曲唑组明显较低,P 值均为0.002。结论来曲唑对绝经后、ER/PR 阳性或不明的晚期乳腺癌患者有效率为23.73%,与氨鲁米特比较无统计学差异。但来曲唑不良反应较氨鲁米特明显低,可以代替氨鲁米特用于晚期绝经后受体阳性或不明乳癌患者的治疗。     

来曲唑对绝经后晚期乳腺癌的治疗效果评价

1998年 4月～ 2 0 0 0年 4月间 ,来曲唑国际乳腺癌协作组共收治绝经后局部晚期或转移性乳腺癌患者 90 7例。该项大样本来自 2 9个国家 2 0 1个中心的多中心双盲Ⅲ期临床试验观察对象。患者随机分成两组 ,接受来曲唑治疗者 45 3例(来曲唑组 ) ,每天 2 5ｍｇ。接受他莫昔芬治疗者 45 4例 (他莫昔芬组 ) ,每天 2 0ｍｇ。观察两组的主要指标为 :从治疗到进展的时间 (ＴＴＰ) ;次要指标为 :总有效率 (ＣＲ ＰＲ)和临床获益率 (ＣＲ ＰＲ ＳＤ)。目前 ,6 6 2例患者已结束治疗 ,中数随访时间为 18个月。两组各项基数均平衡。 2 0 0 %的患者曾…     

来曲唑与氨鲁米特对照治疗绝经后晚期乳腺癌113例

目的 对比来曲唑和氨鲁米特治疗妇女绝经后晚期乳腺癌患者的有效性和耐受性。 方法 采用开放、随机、多中心对照研究。患者随机分组接受口服来曲唑2．5mg．d-1或氨鲁米特1g．d-1的对照治疗。 结果 来曲唑组(n=59)有效率23．73％(CR 2例，PR 12例，ITT有效率21．88％)，SD 20．31％(13例)。氨鲁米特组(n=54)有效 率11．11％(CR 1例，PR 5例，ITT有效率10．17％)，SD 20．34％(12例)，2组疗效无统计学差异(P>0．05)。来曲唑组和氨鲁米特 组不良反应发生率分别为18．64％和42．11％，与治疗相关的不良反应发生率分别为13．56％和33．33％。比较2组总的和与治疗 相关的不良反应发生率均以来曲唑组明显较低，P值均为0．002。 结论 来曲唑对绝经后、ER／PR阳性或不明的晚期乳腺癌患者有效率为23．73％，与氨鲁米特比较无统计学差异。但来曲唑不良 反应较氨鲁米特明显低，可以代替氨鲁米特用于晚期绝经后受体阳性或不明乳癌患者的治疗。     

平消胶囊联合来曲唑治疗晚期绝经后乳腺癌临床观察

目的:观察平消胶囊联合来曲唑治疗晚期绝经后乳腺癌的疗效.方法:85例晚期绝经后乳腺癌患者采用随机对照方法分为实验组44例和对照组4l例.实验组口服来曲唑2.5毫克一日一次,平消胶囊6-8粒一日三次,对照组口服来曲唑2.5毫克一日一次.评价疗效、生活质量、疾病进展时间、生存期、不良反应情况.结果:实验组生活质量改善率高于对照组,两组差异有统计学意义(P＜0.05),实验组疾病进展时间较对照组明显延长,两组差异有统计学意义(P＜0.05).实验组临床获益率、中位生存期高于对照组,但差异无统计学意义(P＞0.05),二组不良反应均轻微.结论:平消胶囊联合来曲唑可提高晚期绝经后乳腺癌患者生活质量、延长疾病进展时间,耐受性好,值得临床推广.     

来曲唑治疗晚期乳腺癌的临床观察

目的:观察来曲唑(Letrozole)治疗晚期乳腺癌的疗效及不良反应。方法:63例晚期乳腺癌患者给予来曲唑(进口或国产)2.5 mg口服,每日1次。结果:63例患者中,可评价疗效者62例,可评价不良反应者63例。完全缓解(CR)0例;部分缓解(PR)9例,占14.5 %;稳定(SD)30例,占48.4 %,其中SD≥6个月10例,占16.1 %;临床获益(CR PR SD≥6个月)19例,占30.6 %;病情进展(PD)23例,占37.1 %。一线治疗9例,有效率44.4 %,临床获益率66.7 %。二线治疗19例,有效率10.5 %,临床获益率36.8 %。三线及以上治疗34例,有效率8.8 %,临床获益率26.5 %。骨、软组织和内脏转移有效率依次为13.3 %、12.8 %和11.9 %。治疗中1例因变态反应停药,其余无严重不良反应。结论:来曲唑治疗晚期乳腺癌有一定疗效,药物不良反应轻,患者易于耐受。     

平消胶囊联合来曲唑治疗晚期绝经后乳腺癌临床观察

目的：观察平消胶囊联合来曲唑治疗晚期绝经后乳腺癌的疗效。方法：85例晚期绝经后乳腺癌患者采用随机对照方法分为实验组44例和对照组41例。实验组口服来曲唑2.5毫克一日一次,平消胶囊6-8粒一日三次,对照组口服来曲唑2.5毫克一日一次。评价疗效、生活质量、疾病进展时间、生存期、不良反应情况。结果：实验组生活质量改善率高于对照组,两组差异有统计学意义（P〈0.05）,实验组疾病进展时间较对照组明显延长,两组差异有统计学意义（P〈0.05）。实验组临床获益率、中位生存期高于对照组,但差异无统计学意义（P〉0.05）,二组不良反应均轻微。结论：平消胶囊联合来曲唑可提高晚期绝经后乳腺癌患者生活质量、延长疾病进展时间,耐受性好,值得临床推广。     

绝经后晚期乳腺癌新辅助内分泌治疗的疗效观察

目的探讨新辅助内分泌治疗对于绝经后晚期乳腺癌治疗的可行性,比较三苯氧胺与来曲唑的疗效。方法 51例绝经后乳腺癌晚期患者随机分为2组,三苯氧胺组26例采用三苯氧胺治疗,来曲唑组25例采用来曲唑治疗,比较并且分析2组的临床效果和毒副反应。结果来曲唑组的总有效率为68.0%,明显高于三苯氧胺组的30.7%,差异有统计学意义（P〈0.05）。2组毒副反应均较轻。结论新辅助内分泌治疗对于绝经后晚期乳腺癌治疗安全有效,而且来曲唑治疗效果优于三苯氧胺。     

Efficacy of first-line letrozole versus tamoxifen as a function of age in postmenopausal women with advanced breast cancer

PURPOSE: To compare the efficacy, in regard to time to progression (TTP) and objective response rate (ORR), of letrozole (Femara; Novartis Pharma AG; Basel Switzerland), an oral aromatase inhibitor, with that of tamoxifen (Tamofen; Leiras OY; Turku, Finland) as first-line therapy in younger (<70 years) and older (>/=70 years) postmenopausal women with advanced breast cancer. MATERIALS AND METHODS: Nine hundred seven patients with advanced breast cancer were randomly assigned to receive 2.5 mg letrozole (n = 453) or 20 mg tamoxifen (n = 454) once daily in a double-blind, multicenter, international trial. Among the prospectively planned analyses were analyses of TTP and ORR by age (<70 and >/=70 years). The results of these prospectively planned analyses are reported here. RESULTS: Letrozole was as effective in older postmenopausal women (>/=70 years of age) as it was in younger postmenopausal women (<70 years of age). The overall ORR in the older subgroup was significantly higher in patients treated with letrozole (38%) than in patients treated with tamoxifen (18%). In the younger subgroup of postmenopausal patients, the ORRs were not significantly different (letrozole, 26%; tamoxifen, 22%). TTP was significantly longer for letrozole than for tamoxifen in both age groups (younger: letrozole median TTP, 8.8 months; tamoxifen, 6.0 months; older: letrozole median TTP, 12.2 months; tamoxifen, 5.8 months). Although age was independently prognostic of TTP, there was no significant effect of age on ORR in the presence of other factors. CONCLUSION: The data show that letrozole, 2.5 mg once daily, is as effective in older, postmenopausal women as it is in younger postmenopausal women with advanced breast cancer. In addition, letrozole was more effective than tamoxifen in both younger and older patients.     

Third-line hormonal treatment with exemestane in postmenopausal patients with advanced breast cancer progressing on letrozole or anastrozole. A phase II trial conducted by the Hellenic Group of Oncology (HELGO)

AIMS AND BACKGROUND: The understanding of hormonal therapies in postmenopausal women with metastatic breast cancer has advanced greatly in the past several decades. With the introduction of orally active, potent and selective third-generation aromatase inhibitors (anastrozole, letrozole and exemestane), approaches to the treatment of hormone-sensitive advanced breast cancer are undergoing reevaluation. For treatment of advanced or metastatic disease that has progressed on tamoxifen, all three agents are active. The purpose of the study was to assess the antitumor efficacy and tolerance of exemestane administered as third-line hormonal therapy to postmenopausal women with metastatic breast cancer refractory to letrozole and anastrozole. STUDY DESIGN: Sixty postmenopausal women with stage IV hormone receptor-positive carcinoma of the breast were enrolled in the study. All patients had received two prior hormonal manipulations and had measurable or assessable disease. All adverse events were monitored. RESULTS: Objective tumor response was achieved in 12 (20%) patients (95% CI, 9.6-30.4). The overall clinical benefit was 38.3% (95% CI, 21.2-49.3), and the median duration of objective tumor response was 20 months (range, 9-26). The median time to death was 17.4 months (95% CI, 16.14-18.66). CONCLUSIONS: Exemestane represents an active and well-tolerated treatment option in pretreated patients with advanced breast cancer who have received standard first- and second line hormonal therapies. By extending the sequence of hormonal therapy, disease progression and the need for chemotherapy may be significantly delayed.     

A phase II, randomized, blinded study of the farnesyltransferase inhibitor tipifarnib combined with letrozole in the treatment of advanced breast cancer after antiestrogen therapy

BACKGROUND: This study assessed the clinical efficacy of the farnesyltransferase inhibitor, tipifarnib, combined with letrozole in patients with advanced breast cancer and disease progression following antiestrogen therapy. PATIENTS AND METHODS: Postmenopausal women with estrogen-receptor-positive advanced breast cancer that had progressed after tamoxifen were given 2.5 mg letrozole once daily and were randomly assigned (2:1) to tipifarnib 300 mg (TL) or placebo (L) twice daily for 21 consecutive days in 28-day cycles. The primary endpoint was objective response rate. RESULTS: Of 120 patients treated with TL (n = 80) or L (n = 40), 113 were evaluable for response. Objective response rate was 30% (95% CI; 20-41%) for TL and 38% (95% CI; 23-55%) for L. There was no significant difference in response duration, time to disease progression or survival. Clinical benefit rates were 49% (TL) and 62% (L). Tipifarnib was generally well tolerated; a higher incidence of drug-related asymptomatic grade 3/4 neutropenia was observed for TL (18%) than for L (0%). Tipifarnib population pharmacokinetics were similar to previous studies, with no significant difference in trough letrozole concentrations between the TL and L groups. CONCLUSIONS: Adding tipifarnib to letrozole did not improve objective response rate in this population of patients with advanced breast cancer.     

Approval summary: letrozole in the treatment of postmenopausal women with advanced breast cancer.

Letrozole (Femara; Novartis Pharmaceuticals Corp., East Hanover, NJ) is a nonsteroidal inhibitor of aromatase enzyme complex. It inhibits the peripheral conversion of circulating androgens to estrogens. In postmenopausal women, letrozole decreases plasma concentrations of estradiol, estrone, and estrone sulfate by 75-95% from baseline with maximal suppression achieved within 2-3 days of treatment initiation. Suppression is dose related, with doses of >or=0.5 mg giving estrone and estrone sulfate values that were often below assay detection limits. At clinically used dosage, letrozole does not impair adrenal synthesis of glucocorticoids or aldosterone. In 1998, letrozole was approved by the United States Food and Drug Administration (FDA) for the treatment of advanced breast cancer in postmenopausal women, with hormone receptor positive or unknown breast cancer, who had failed one prior antiestrogen treatment (i.e., for "second-line" treatment). Approval was based on two randomized trials comparing tumor RRs of patients receiving 0.5 mg of letrozole, 2.5 mg of letrozole, and either megestrol acetate (MA) or aminoglutethimide. In the megestrol trial, 2.5 mg/day letrozole was superior to 0.5 mg of letrozole and MA (RRs 24, 13, and 16%, respectively), whereas in the aminoglutethimide trial, there was no significant difference in 2.5 mg of letrozole and 0.5 mg of letrozole RRs (20 and 17%). There was a trend toward RR superiority of 2.5 mg of letrozole over aminoglutethimide (P = 0.06). Letrozole (2.5 mg) was the dose chosen for comparison with tamoxifen in the first-line setting. In July 2000, a marketing application for first-line letrozole treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer was submitted to the FDA. A single double-blind, double dummy, randomized, and multicenter trial compared 2.5 mg of letrozole to 20 mg of tamoxifen (456 patients/arm). Letrozole was superior to tamoxifen with regard to time to progression (TTP) and objective response rate (RR). The median TTP for letrozole treatment was 9.9 months [95% confidence interval (CI) 9.1-12.2] versus 6.2 months (95% CI 5.8-8.5) for tamoxifen, P = 0.0001, hazard ratio 0.713, (95% CI 0.61-0.84). RR was 32% for letrozole versus 21% for tamoxifen (odds ratio 1.74, 95% CI 1.29-2.34, P = 0.0003). Preliminary survival data (survival data are still blinded) indicate that letrozole is unlikely to be worse than tamoxifen. Both treatments were similarly tolerated. On the basis of these results, the United States FDA approved letrozole tablets, 2.5 mg/day, for first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer. The manufacturer made a commitment to provide updated information on survival.     

Increase in response rate by prolonged treatment with neoadjuvant letrozole

Purpose The aim of this study was to investigate the potential benefits of prolonged treatment with neoadjuvant letrozole. Patients and Methods About 182 consecutive patients have been treated in Edinburgh with neoadjuvant letrozole for 3 months or longer and 63 patients have continued on letrozole beyond 3 months. Outcomes are reported. Results Of the 63 patients who continued on letrozole, 38 patients took letrozole for more than 1 year and 23 took letrozole for more than 24 months. The median reduction in clinical volume in the first 3 months in these 63 patients was 52%. Similar reductions in median clinical volume were seen between three to 6 months (50%), 6–12 months and 12–24 months (medians 37 and 33%, respectively). At 3 months 69.8% of the 182 patients had a partial or complete response. The response rate increased to 83.5% with prolonged letrozole treatment. Continuing letrozole beyond 3 months increased the number of women who initially required mastectomy or had locally advanced breast cancer who were subsequently suitable for breast conserving surgery from 60% (81/134) at 3 months to 72% (96/134). Thirty-three women remain on letrozole alone (man age at diagnosis 83 years) and at 3 years the median time to treatment failure has not been reached. Conclusion Continuing letrozole in responding patients beyond 3–4 months achieves further clinical reduction in tumour size. For elderly women with a short life expectancy letrozole alone may provide long-term disease control.     

Superiority of letrozole to tamoxifen in the first-line treatment of advanced breast cancer: evidence from metastatic subgroups and a test of functional ability

PURPOSE: The letrozole study 025 is a large (n = 907), international, double-blind, randomized, phase III trial in postmenopausal women with advanced breast cancer. This subanalysis compares the efficacies of letrozole and tamoxifen as first-line therapy in postmenopausual women with advanced breast cancer according to site of metastatic lesions and Karnofsky Performance Status (KPS). MATERIALS AND METHODS: Nine hundred seven patients with advanced breast cancer were randomly assigned to once-daily oral letrozole (2.5 mg; Femara; Novartis Pharma AG; Basel, Switzerland) or tamoxifen (20 mg; Tamofen; Leiras OY; Turku, Finland). Time to progression (TTP) was estimated using the Kaplan-Meier product-limit method. Treatments were compared by Cox proportional hazards regression models. RESULTS: Letrozole treatment significantly prolonged TTP in all subsets of patients: those with nonvisceral metastases, those with visceral metastases without liver involvement, and those with liver metastases. The reduction in risk of progression ranged from 25%, for patients with nonvisceral metastases, to 36%, for patients with liver metastases. The distributions of baseline KPS scores for both treatment groups were similar (57% had KPS scores >/=90). Time to worsening of 20 points or more in KPS score was significantly longer with letrozole than with tamoxifen, but modest numbers of patients experienced such deterioration (letrozole, 20%, tamoxifen, 22%, in patients without visceral metastases; 23%-24% in patients with liver metastases; and letrozole, 14%, tamoxifen, 30%, in patients with visceral metastases without liver involvement). CONCLUSION: These data demonstrate the consistent superiority of letrozole over tamoxifen and support the use of letrozole as a new standard of endocrine therapy in postmenopausal women with advanced breast cancer.     

Superior efficacy of letrozole versus tamoxifen as first-line therapy for postmenopausal women with advanced breast cancer: results of a phase III study of the International Letrozole Breast Cancer Group.

PURPOSE: To compare the efficacy and tolerability of tamoxifen with that of letrozole, an oral aromatase inhibitor, with tamoxifen as first-line therapy in postmenopausal women with advanced breast cancer. PATIENTS AND METHODS: Nine hundred seven patients were randomly assigned letrozole 2.5 mg once daily (453 patients) or tamoxifen 20 mg once daily (454 patients). Patients had estrogen receptor- and/or progesterone receptor-positive tumors, or both receptors were unknown. Recurrence during adjuvant antiestrogen therapy or within the following 12 months or prior endocrine therapy for advanced disease precluded enrollment. One prior chemotherapy regimen for metastatic disease was allowed. The primary end point was time to progression (TTP). Secondary end points included overall objective response rate (ORR), its duration, rate and duration of clinical benefit, time to treatment failure (TTF), overall survival, and tolerability. RESULTS: TTP was significantly longer for letrozole than for tamoxifen (median, 41 v 26 weeks). Treatment with letrozole reduced the risk of progression by 30% (hazards ratio, 0.70; 95% confidence interval, 0.60 to 0.82, P =.0001). TTP was significantly longer for letrozole irrespective of dominant site of disease, receptor status, or prior adjuvant antiestrogen therapy. Similarly, TTF was significantly longer for letrozole (median, 40 v 25 weeks). ORR was higher for letrozole (30% v 20%; P =.0006), as was the rate of clinical benefit (49% v 38%; P =.001). Survival data are currently immature and not reported here. Both treatments were well tolerated. CONCLUSION: Letrozole was significantly superior to tamoxifen in TTP, TTF, ORR, and clinical benefit rate. Our results support its use as first-line endocrine therapy in postmenopausal women with advanced breast cancer.     

A decade of letrozole: FACE

Third-generation nonsteroidal aromatase inhibitors (AIs), letrozole and anastrozole, are superior to tamoxifen as initial therapy for early breast cancer but have not been directly compared in a head-to-head adjuvant trial. Cumulative evidence suggests that AIs are not equivalent in terms of potency of estrogen suppression and that there may be differences in clinical efficacy. Thus, with no data from head-to-head comparisons of the AIs as adjuvant therapy yet available, the question of whether there are efficacy differences between the AIs remains. To help answer this question, the Femara versus Anastrozole Clinical Evaluation (FACE) is a phase IIIb open-label, randomized, multicenter trial designed to test whether letrozole or anastrozole has superior efficacy as adjuvant treatment of postmenopausal women with hormone receptor (HR)- and lymph node-positive breast cancer. Eligible patients (target accrual, N=4,000) are randomized to receive either letrozole 2.5 mg or anastrozole 1 mg daily for up to 5 years. The primary objective is to compare disease-free survival at 5 years. Secondary end points include safety, overall survival, time to distant metastases, and time to contralateral breast cancer. The FACE trial will determine whether or not letrozole offers a greater clinical benefit to postmenopausal women with HR+ early breast cancer at increased risk of early recurrence compared with anastrozole.