In postmenopausal hormone receptor positive breast cancer, treatment with aromatase inhibitors is the most effective and well-studied therapy. Lack of adherence is common due to the side-effects
Conditions
Interventions
Trade Name: Blissel
Pharmaceutical Form: Vaginal gel
INN or Proposed INN: ESTRIOL
Current Sponsor code: ESTRIOL
Concentration unit: % pe
Sponsors
ITF Research Pharma S.L.U
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent prior to beginning specific protocol procedures. 2. Patients must have histological confirmation of breast adenocarcinoma with stage I-IIIA, documented at a local pathology department. 3. The breast tumors must be estrogen-receptor positive and/or progesterone receptor positive (?1% of stained tumor cells by IHC as determined by the local laboratory) with any HER2 status. 4. Postmenopausal status defined as: 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy. 5. Patient must be receiving the non-steroidal aromatase inhibitors anastrozole or letrozole as breast cancer treatment in the adjuvant setting for a minimum of 6 months. 6. Women suffering from moderate to severe vaginal dryness according to the FDA guidelines for drug development in postmenopausal women (Center for Drug Evaluation and Research, CDER Jan 2003). A moderate symptom will be considered if the symptom is present, bothersome and annoying, and a severe symptom will be considered if the symptom is present, bothersome and annoying, and interferes with the normal patient activity. 7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 8. Adequate bone marrow as defined by the following laboratory values: a. Absolute Neutrophil Count (ANC) ? 1.5 x 109/L. b. Platelets (plt) ? 100 x 109/L. c. Hemoglobin (Hgb) ? 10 g/dl. 9. Patient has adequate organ function as defined by the following laboratory values: d. Serum creatinine ? 1.5 x ULN. e. Bilirubin ? 1.5 × ULN. f. Alkaline phosphatase ? 2 × ULN. g. AST and ALT ? 2 × ULN. 10. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Stage IIIB-IV breast cancer or bilateral breast cancer. 2. Treatment with any other current anti-tumoral therapy (chemotherapy, anti-Her2?etc) besides the NSAI. Pamidronate or Alendronate are permitted. 3. Prior history of other malignancy within 5 years of study entry, aside from non-melanoma skin cancer or carcinoma-in-situ of the uterine cervix adequately treated. 4. Postmenopausal uterine bleeding. Vaginal bleeding of unknown etiology. 5. Patients with endometrial thickness equal to or greater than 4 mm measured by transvaginal ultrasound. 6. Patients who have received any type of vulvovaginal treatment in the 15 days prior to the start of the study. 7. Use of any hormone, natural (phytoestrogens) or herbal products for the treatment of menopausal symptoms within the last 6 months. 8. Current or previous history of thromboembolic disease or coagulopathies. 9. Severe cardiovascular or respiratory diseases in the previous 6 months. 10. Renal Impairment. 11. Hepatitis B and/or hepatitis C carriers (unless with normal hepatic function). 12. Known human immunodeficiency virus infection. 13. Known hypersensitivity to NSAI. 14. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study. 15. Previous investigational treatment for any condition or participation in any clinical trial within 4 weeks of inclusion date.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the levels of FSH after treatment with 0.005% estriol vaginal gel in hormone receptor-positive postmenopausal women with early stage breast cancer in treatment with NSAIs in the adjuvant setting and symptoms of vaginal atrophy; Secondary Objective: To evaluate the levels of estriol, estradiol, estrone, FSH and LH after treatment with 0.005% estriol vaginal gel in hormone receptor-positive postmenopausal women with early stage breast cancer in treatment with NSAIs in the adjuvant setting and symptoms of vaginal atrophy. To assess the safety and tolerability of 0.005% estriol vaginal gel in hormone receptor-positive postmenopausal women with early stage breast cancer in treatment with NSAIs in the adjuvant setting and symptoms of vaginal atrophy. To assess the efficacy of 0.005% estriol vaginal gel in the treatment of symptoms and signs of vaginal atrophy in hormone receptor-positive postmenopausal women with early stage breast cancer in treatment with NSAIs and symptoms of vaginal atrophy. To measure the impact of treatment with 0.005% estriol vaginal gel in sexual function of hormone receptor-positive postmenopausal women with early stage breast cancer in treatment with NSAIs and symptoms of vaginal atrophy ;Primary end point(s): Variation in serum levels of FSH from baseline to 12 weeks of treatment.;Timepoint(s) of evaluation of this end point: 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Variation in serum levels of FSH at different time points compared to baseline (weeks 1, 3 and 8). Variation in serum levels of LH and plasma levels of estriol, estradiol and estrone, at different time points compared to baseline (weeks 1, 3, 8 and 12). AEs according to the Medical Dictionary for Regulatory Activities (MedDRA) Changes in vaginal dryness and other symptoms and signs of vaginal atrophy; changes in vaginal maturation value and changes in vaginal pH at week 3 and week 12 vs baseline. Changes in sexual function measured by the Female Sexual Function Index (FSFI ) scale at week 3 and week 12 vs baseline. ;Timepoint(s) of evaluation of this end point: Weeks 1, 3, 8, 12 of treatment | — |
Countries
Spain, Sweden
Contacts
Public ContactGEICAM
GEICAM Spanish Breast Cancer Group
Outcome results
None listed