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Triptorelin 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

2013年6月25日更新者：Gruppo Italiano Mammella (GIM)

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]

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.

研究概览

地位

完全的

条件

乳腺癌

干预/治疗

详细说明

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.

OUTLINE: This is a prospective, open-label, multicenter, randomized study. Patients are randomized to 1 of 2 treatment arms.

Arm I (adjuvant chemotherapy alone): Patients receive adjuvant chemotherapy alone.
Arm II (adjuvant chemotherapy and triptorelin): Patients receive adjuvant chemotherapy and triptorelin intramuscularly 1 week before and then every 4 weeks for the duration of chemotherapy. The last dose of triptorelin is given before the last course of chemotherapy.

Patients with hormone-sensitive tumors who resume ovarian function after stopping chemotherapy and triptorelin restart triptorelin until ovarian function is suppressed for 2 years.

Patients undergo menopausal status assessment, using follicle-stimulating hormone, luteinizing hormone, and estradiol as biochemical markers, at baseline and 3, 6, 9, and 12 months after the last course of chemotherapy.

After completion of study treatment, patients are followed at 3, 6, 9, and 12 months.

PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study.

研究类型

介入性

注册 (预期的)

280

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

意大利
- - Castelfranco - TV、意大利、31033
    - Ospedale Civile
  - Como、意大利、22100
    - Ospedale Sant Anna
  - Cuneo、意大利、12100
    - Ospedale Santa Croce
  - Florence、意大利、50011
    - Azienda Ospedaliera di Firenze
  - Genoa、意大利、16132
    - Istituto Nazionale per la Ricerca sul Cancro
  - Livorno、意大利、57100
    - Presidio Ospedaliero Di Livorno
  - Mantova、意大利、46100
    - Carlo Poma Hospital
  - Naples、意大利、80131
    - Federico II University Medical School
  - Naples、意大利、80131
    - Seconda Universita di Napoli
  - Naples、意大利、81131
    - Istituto G. Pascale
  - Perugia、意大利、06156
    - Ospedale Silvestrini
  - Pisa、意大利、56126
    - Ospedale Santa Chiara Pisa
  - Rome、意大利、00128
    - Istituto Regina Elena
  - Sassari、意大利、07100
    - Ospedale Civile ASL 1
  - Sora、意大利、03039
    - Ospedale SS Trinità
  - Treviglio、意大利、24047
    - Ospedale Treviglio Caravaggio
  - Trieste、意大利、34100
    - Ospedale Maggiore dell' Universita
  - Turin、意大利、10126
    - Università di Torino

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 45年 (成人)

接受健康志愿者

不

有资格学习的性别

女性

描述

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:

Female
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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：支持治疗
分配：随机化
屏蔽：无（打开标签）

研究衡量的是什么？

主要结果指标

结果测量
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

次要结果测量

结果测量
Toxicity as measured by Common Toxicity Criteria at each chemotherapy course

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Gruppo Italiano Mammella (GIM)

调查人员

学习椅：Lucia Del Mastro, MD、IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2003年9月1日

初级完成 (实际的)

2008年1月1日

研究完成 (实际的)

2008年4月1日

研究注册日期

首次提交

2006年4月5日

首先提交符合 QC 标准的