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: 14.1 Level: LLT Classification code 10006283 Term: Breast neoplasm malignant female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: VAGIFEM*15CPR VAG 25MCG
Pharmaceutical Form: Vaginal tablet
INN or Proposed INN: ESTRADIOL HYDRATE
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: µg
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
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 ( 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
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Targeted Quality of Life (sexual functioning) of patients during treatment. - Efficacy of Vagifem in terms of vulvovaginal epithelial maturation during treatment. - 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) | — |
Countries
Italy
Contacts
Public ContactUfficio studi clinici
Istituto Europeo Oncologia
Outcome results
None listed