Clinical trial to evaluate the safety of a vaginal gel containing 0.005% of estriol, in hormone receptor-positive women in menopause with early stage breast cancer in treatment with aromatase inhibitor

Phase 1

Conditions: 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
vaginal dryness and vaginal atrophy. The study will explore the safety of 0.005% estriol vaginal gel in the oncological context, to demostrate that the gel is a safe option to treat the vaginal atrophy caused by AIs, without a significant decline in gonadotropin or increase in systemic estrogen levels
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2014-004517-84-ES

Lead Sponsor: ITF Research Pharma S.L.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 61

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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