A phase II study of low-dose vaginal estrogens in pre and postmenopausal breast cancer patients with urogenital atrophy

ISTITUTO EUROPEO DI ONCOLOGIA0 个研究点目标入组 67 人开始时间: 2012年3月1日最近更新: 2012年3月20日

适应症

试验速览

暂无简介。

•Patients mast have histologically proven primary breast cancer;
•Age 18-70 years;
•Immunohistochemical evaluation of ER, PgR, HER2, is mandatory;
•ER and/or PgR must be = 10%
•Postmenopausal level of serum estrogen (< 5 – 30 pg/ml );
•Patients must have had proper surgery for primary breast cancer;
•Patients should be treated with hormone therapy (Tamoxifene, letrozole, anastrozole, exemestane and/or LH-RH analogue);
•Urogenital symptoms (Vaginal dryness, Vaginal atrophy, Dyspareunia, Decreased libido, Urinary urgency/frequency ); patients must be refractory to local non-hormonal treatments for urogenital symptoms;
•No evidence of distant metastatic disease;
•ECOG performance status <2;
•No significant co-morbidities ( > grade 2);
•Signed informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 27

•Patients with previous or concomitant malignancy;
•Patients who exceed the postmenopausal estradiol serum level of 30 pg/ml at baseline;
•Uncontrolled undercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
•Patients who have received prior therapy for breast cancer;
•Patients who have received endometrial biopsy;

发起方