Postmenopausal women with hormone-receptor positive, node positive early breast cancer will have treatment with continuous letrozole compared with treatment with intermittent letrozole after 4 to 6 years of prior adjuvant endocrine treatment to see which is better at preventing the return of cancer.

ovartis Pharma AG0 个研究点目标入组 4,800 人开始时间: 2008年5月12日最近更新: 2020年1月13日

适应症

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•Patients must be postmenopausal. Have had operable, non-inflammatory breast cancer at diagnosis. Must be clinically disease-free at randomisation. Have had ER and/or PgR positive tumours after primary surgery and before commencement of prior endocrine therapy. Following primary surgery, patients must have had evidence of lymph node involvement either in the axillary or internal mammary nodes, but not supraclavicular nodes. Must have had proper local treatment including surgery with/without radiotherapy for primary breast cancer with no known clinical residual loco-regional disease. Patients must have clinically adequate hepatic function. Patients must have completed 4 to 6 years of prior adjuvant endocrine therapy with selective estrogen receptor modulators (SERM(s)), aromatase inhibitors(AI(s)), or a sequential combination of both (neoadjuvant endocrine therapy should not be included). Patients must have stopped prior endocrine SERM/AI therapy, and must be randomised within 12 months of the last dose of prior endocrine SERM/AI therapy. Patients may have received any type of prior adjuvant therapy, including but not limited to neoadjuvant chemotherapy, neoadjuvant endocrine therapy, adjuvant chemotherapy, trastuzumab, ovarian ablation, GnRH analogues, lapatinib. Pathology material from the primary tumour must be available for submission for central review. Written Informed Consent, and written consent to pathology material submission. Must be accessible for follow-up.

•Evidence of recurrent disease or distant metastatic disease at any time prior to randomisation. Patients who have had bilateral breast cancer. Bone fracture due to osteoporosis at any time during the 4-6 years of prior SERM/AI therapy. Previous or concomitant malignancy EXCEPT adequately treated: basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, contra- or ipsilateral in situ breast carcinoma. Other non-malignant systemic diseases (cardiovascular, renal, lung, etc.) that would prevent prolonged follow-up. Psychiatric, addictive, or any disorder which compromises compliance with protocol rquirements. Concurrent hormone replacement therapy, bisphosphonates (except for treatment of bone loss), or any investigational agent at randomisation.

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