ACTRN12605000416695进行中（未招募）2 期
IBCSG 24-02 / BIG 2-02: Suppression of Ovarian Function Trial. A phase III trial evaluating the role of ovarian function suppression and the role of Exemestane as adjuvant therapies for premenopausal women with endocrine responsive breast cancer.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,066
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- Female
入选标准
- •Pre-menopausal women with histologically proven, hormone receptor positive, completely resected breast cancer which is confined to the breast and axillary nodes without metastases; axillary node dissection or a negative axillary sentinel node biopsy; geographically accessible for follow up; written informed consent provided.
排除标准
- •Post-menopausal women; distant metastatic disease; locally advanced inoperable breast cancer; supraclavicular node involvement; enlarged internal mammary nodes; bilateral invasive breast cancer; positive final margins; clinically detectable residual axillary disease; history of prior ipsilateral or contralateral invasive breast cancer; previous or concomitant malignancy; other non-malignant systemic diseases that would prevent prolonged follow-up; bilateral oophorectomy or ovarian irradiation or are planning oophorectomy within 5 years of entry; pregnant or lactating at randomization; desire a pregnancy within 5 years or plan to use additional hormone therapy during next 5 years (including hormonal contraception); neoadjuvant or adjuvant endocrine therapy for more than 6 months after breast cancer diagnosis; tamoxifen or other SERM or HRT within 1 year prior to breast cancer diagnosis; patients who have received GnRH analogues as part of their breast cancer treatment prior to randomisation.
研究者
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