NCT00311636已完成3 期
Prevention of Chemotherapy-induced Menopause by Temporary Ovarian Suppression With Triptorelin Vs. Control in Young Breast Cancer Patients. A Randomized Phase III Multicenter Study [PROMISE]
Gruppo Italiano Mammella (GIM)36 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2003年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 36
- 主要终点
- Chemotherapy-induced early menopause as measured by follicle-stimulating hormone, 17 beta estradiol levels, and menstrual activity resumption at 1 year following the completion of chemotherapy
研究概览
简要总结
RATIONALE: Chemotherapy may cause early menopause in premenopausal women. Triptorelin may prevent this from happening.
PURPOSE: This randomized phase III trial is studying triptorelin to see how well it works in preventing early menopause in premenopausal women who are receiving chemotherapy for stage I, stage II, or stage III breast cancer that has been removed by surgery.
详细描述
OBJECTIVES:
Primary
- Evaluate the incidence of chemotherapy-induced early menopause in premenopausal women undergoing adjuvant chemotherapy in combination with vs without triptorelin for previously resected stage I-III breast cancer.
Secondary
- Compare the toxicity of adjuvant chemotherapy and triptorelin vs adjuvant chemotherapy alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed breast cancer resected at time of original diagnosis
- •Stage I-III disease
- •Candidate for 1 of the following adjuvant chemotherapy regimens:
- •FEC (fluorouracil, epirubicin hydrochloride, and cyclophosphamide) every 21 or 28 days
- •CMF (cyclophosphamide, methotrexate, and fluorouracil) every 28 days
- •A→CMF (doxorubicin hydrochloride followed by CMF)
- •EC→P (epirubicin hydrochloride and cyclophosphamide every 21 days followed by paclitaxel every 21 days)
- •FEC→P (FEC every 21 days followed by paclitaxel every 21 days)
- •EC→D (EC every 21 days followed by docetaxel every 21 days)
- •AC (doxorubicin hydrochloride and cyclophosphamide) every 21 days
- •AC→P (AC every 21 days followed by paclitaxel every 21 days)
- •E→CMF (epirubicin hydrochloride followed by CMF every 28 days)
- •No evidence of metastases or localized or distant recurrence
- •Investigation to exclude metastases required for any suspicious manifestation
- •Premenopausal, defined as the presence of active menstrual cycles or normal menses within six weeks before initiation of chemotherapy
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or adequately treated in situ carcinoma of the cervix
- •No history of noncompliance to medical regimens or patients who are considered potentially unreliable
- •Not pregnant or nursing
- •Negative pregnancy test
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior chemotherapy and/or radiotherapy for cancer or non-neoplastic disease
- •No other concurrent hormonal therapy except for tamoxifen
排除标准
- 未提供
结局指标
主要结局
Chemotherapy-induced early menopause as measured by follicle-stimulating hormone, 17 beta estradiol levels, and menstrual activity resumption at 1 year following the completion of chemotherapy
次要结局
- Toxicity as measured by Common Toxicity Criteria at each chemotherapy course
研究者
研究点 (36)
Loading locations...
相似试验
已完成
3 期
Goserelin in Preventing Early Menopause in Premenopausal Women Undergoing Chemotherapy for Stage I, Stage II, or Stage III Breast CancerMenopausal SymptomsInfertilityBreast CancerNCT00427245Anglo Celtic Cooperative Oncology Group400
已完成
2 期
LY353381 in Preventing Breast Cancer in Women With HyperplasiaBreast CancerNCT00005879University of Kansas Medical Center199
已完成
2 期
Tretinoin With or Without Fenretinide in Treating Patients With Dysplastic Nevus SyndromeMelanoma (Skin)NCT00003601Eastern Cooperative Oncology Group38
已完成
3 期
Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast CancerBreast CancerNCT00078832Queen Mary University of London3,864
撤回
2 期
Estrogen Therapy as Prevention in the Progression of Aneurysm (EPPA) TrialCerebral AneurysmTreatmentMenopauseNCT01895881Rush University Medical Center