The fase II study evaluates the safety and efficacy of treatment with low doses of topical vaginal estrogen in pre- and postmenopausal patients with breast cancer and urogenital symptoms related to adjuvant hormone therapy

• Conditions: Pre- and postmenopausal women who are receiving adjuvant endocrine treatment (LH-RH analogue plus Tamoxifene or Aromatase Inhibitor, Tamoxifene alone, Aromatase Inhibitor alone) for early breast cancer.; MedDRA version: 14.1Level: LLTClassification code 10006283Term: Breast neoplasm malignant femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-024603-26-IT
• Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-01
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 67

Inclusion Criteria

•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

Exclusion Criteria

•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;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to evaluate the safety and the efficacy of treatment with low doses of vaginal estrogens in pre and post menopausal patients with previous diagnosis of breast cancer and urogenital symptoms related to the adjuvant hormonal therapy;Secondary Objective: The evaluation of quality of life and the Efficacy of Vagifem in terms of vulvovaginal epithelial maturation during treatment;Primary end point(s): maintenance of serum estradiol levels in postmenopausal range.;Timepoint(s) of evaluation of this end point: at the baseline, at the 8th day of treatment and at the 28th day

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Targeted Quality of Life (sexual functioning) of patients during treatment.<br>- Efficacy of Vagifem in terms of vulvovaginal epithelial maturation during treatment.<br>- Estradiol serum levels during the study period and follow up.;Timepoint(s) of evaluation of this end point: At baseline, Day 28, 6th month, yearly (from year 1 to year 5)