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临床试验/ACTRN12605000419662
ACTRN12605000419662终止3 期

IBCSG 26-02 / BIG 4-02: Premenopausal Endocrine Responsive Chemotherapy Trial A phase III trial evaluating the role of chemotherapy as adjuvant therapy for premenopausal women with endocrine responsive breast cancer who receive endocrine therapy.

Australia and New Zealand Breast Cancer Trials Group Ltd0 个研究点目标入组 1,750 人开始时间: 2005年9月16日最近更新:
适应症

试验速览

阶段
3 期
状态
终止
发起方
入组人数
1,750

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, completely resected, hormone receptor positive breast cancer confined to the breast and axillary nodes without metastases; axillary node dissection or a negative axillary sentinel node biopsy is required; 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; pregnant or lactating at randomisation, 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 after breast cancer diagnosis; tamoxifen or other SERM or HRT within 1 year prior to breast cancer diagnosis; prior neoadjuvant or adjuvant chemotherapy.

研究者

发起方
Australia and New Zealand Breast Cancer Trials Group Ltd

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