EUCTR2007-001370-88-GR进行中（未招募）1 期
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 4,884 人开始时间: 2010年10月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,884
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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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
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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)EUCTR2007-001370-88-GBInternational Breast Cancer Study Group (IBCSG)4,800