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

ISTITUTO EUROPEO DI ONCOLOGIA0 sites67 target enrollmentMarch 1, 2012

Overview

Phase: Not Applicable
Intervention: Not specified
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.
Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA
Enrollment: 67
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

March 1, 2012

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•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;

•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;