A phase III trial evaluating the role of continuous letrozole versus intermittent letrozole following 4 to 6 years of prior adjuvant endocrine therapy for postmenopausal women with hormone-receptor positive, node positive early stage breast cancer - Study of Letrozole Extension (SOLE)

International Breast Cancer Study Group (IBCSG)0 个研究点目标入组 4,800 人开始时间: 2008年11月11日最近更新: 2020年7月6日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 4,800

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: Female

入选标准

•Patients must be postmenopausal using any one of the following criteria. Because letrozole is not effective in pre- or perimenopausal patients, and may stimulate ovarian function, definitive confirmation of postmenopausal status is required:
•Patients of any age who have had a bilateral oophorectomy (including radiation castration AND amenorrheic for > 3 months)
•Patients 56 years old or older. If the patient has any evidence of ovarian function, biochemical evidence of definite postmenopausal status (defined as estradiol, LH, and FSH in the postmenopausal range) is required.
•Patients 55 years old or younger must have biochemical evidence of definite postmenopausal status (defined as estradiol, LH, and FSH in the postmenopausal range). Patients who have received prior LHRH analogue within the last year are eligible if they have definite evidence of postmenopausal status as defined above.
•Patients must be accessible for follow-up.
•At diagnosis, patients must have had operable, non-inflammatory breast cancer.
•Patients must be clinically disease-free at randomization.
•Patients must have had steroid hormone receptor positive tumors (ER and/or PgR), determined by immunohistochemistry, after primary surgery and before commencement of prior endocrine therapy.
•Following primary surgery, eligible patients must have had evidence of lymph node involvement either in the axillary or internal mammary nodes, but not supraclavicular nodes.
•There must have been no evidence of recurrent disease or distant metastatic disease at any time prior to randomization.
•Patients must have had proper local treatment including surgery with or 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 SERM(s), aromatase inhibitor(s), or a sequential combination of both. When calculating 4-6 years, neoadjuvant endocrine therapy should not be included.
•Patients must have stopped prior endocrine SERM/AI therapy, and must be randomized within 12 months (1 year) 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.
•Patients must have stopped hormone replacement therapy (HRT), bisphosphonates (except for treatment of bone loss), or any investigational agent at randomization. (Note: These agents are also not permitted during trial treatment.)
•Pathology material from the primary tumor must be available for submission for central review as part of the quality control measures for this protocol.
•Written Informed Consent (IC) and written consent to pathology material submission must be signed and dated by the patient and the
•investigator prior to randomization.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 3600
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1200

排除标准

•Patients who have had bilateral breast cancer.
•Patients who have had a bone fracture due to osteoporosis at any time during the 4-6 years of prior endocrine SERM/AI therapy.
•Patients who have had any 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.
•Patients who have had any other non-malignant systemic diseases (cardiovascular, renal, lung, etc.) that would prevent prolonged follow-up.
•Patients with psychiatric, addictive, or any disorder which compromises compliance with protocol requirements.

研究者

发起方

International Breast Cancer Study Group (IBCSG)

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A phase III trial evaluating the role of continuous letrozole versus intermittent letrozole following 4 to 6 years of prior adjuvant endocrine therapy for postmenopausal women with hormone-receptor positive, node positive early stage breast cancer. - SOLE Study of Letrozole ExtensioPostmenopausla women who are disease-free following 4-6 years of prior adjuvant endocrine therapy with selective estrogen receptor modulator(s) (SERM) and/or aromotase inhibitor(s) (AI) for endocrine-responsive, node-positive breast cancer.MedDRA version: 14.1Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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