Effects of Vaginal Estrogen on Serum Estradiol During Aromatase Inhibitor Therapy in Breast Cancer Patients with Vulvovaginal Atrophy: a Prospective Trial

NCT06654570 | Completed Phase 2

• 1 other identifier: 2019-001234-34
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: This study aimed to analyze changes in serum estradiol (E2) levels during concurrent vaginal estradiol therapy and adjuvant letrozole in postmenopausal breast cancer (BC) patients with vulvovaginal atrophy (VVA). Secondary objectives included assessing the effects of therapy on vaginal atrophy, quality of life (QoL) and menopause-related symptoms. Methods: Postmenopausal patients undergoing adjuvant letrozole therapy and experiencing VVA symptoms were treated with vaginal estradiol for 12 weeks. Gynecologic examination and symptom screening were conducted at baseline and after 12 weeks. Serum E2 levels were analyzed at baseline, and at two, four, eight, and 12 weeks. E2 levels were measured using both a routine liquid chromatography-tandem mass spectrometry (LC-MS/MS) method and a highly sensitive (hsE2-MS) LC-MS/MS method.

Conditions

Breast Cancer

Keywords

breast cancer, adjuvant, letrozole, estradiol, vulvovaginal atrophy

Outcome Measures

Primary Outcomes (1)

• Serum estradiol level

  The primary objective was to analyze changes in serum E2 levels using two LC-MS/MS methods during concurrent adjuvant AI therapy and intravaginal estradiol treatment. ). Blood samples were collected at baseline, prior to the initiation of study treatment, and at two, four, eight, and 12 weeks thereafter, within 24 to 60 hours of vaginal tablet administration. Serum E2 levels were measured using both a routine LC-MS/MS method (Sciex Citrine™ Triple Quad™ LC-MS/MS system, E2-MS, HUSLAB, LLOQ 10 pmol/L) and a highly sensitive LC-MS/MS method (hsE2-MS, LLOQ 5 pmol/L, CV \< 20%, LOD 1 pmol/L). The hsE2-MS method allowed for the detection of very low serum E2 concentrations, even below the LLOQ, within the range of 1-5 pmol/L, providing a precise assessment of the effect of letrozole and vaginal estrogen on E2 levels.

  12 weeks

Study Arms (1)

Intravaginal estradiol during adjuvant letrozole

EXPERIMENTAL

Eligible patients were treated with Vagifem® (17β-estradiol hemihydrate) 10 μg vaginal tablets for 12 weeks. Patients were instructed to insert one vaginal tablet daily using the provided applicator for 14 consecutive days, followed by one tablet twice weekly (Monday and Thursday evenings).

Drug: Intravaginal estrogen during adjuvant letrozole

Interventions

Intravaginal estrogen during adjuvant letrozole DRUG

Postmenopausal patients undergoing adjuvant letrozole therapy and experiencing VVA symptoms were treated with vaginal estradiol for 12 weeks. Gynecologic examination and symptom screening were conducted at baseline and after 12 weeks. Serum E2 levels were analyzed at baseline, and at two, four, eight, and 12 weeks. E2 levels were measured using both a routine liquid chromatography-tandem mass spectrometry (LC-MS/MS) method and a highly sensitive (hsE2-MS) LC-MS/MS method.

Intravaginal estradiol during adjuvant letrozole

Eligibility Criteria

• Age: 51 Years+
• Gender Eligibility Details: Females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients were postmenopausal women (\> 50 years old) with early-stage hormone receptor-positive BC treated with adjuvant letrozole for at least six months and developed symptoms of AV during this period.

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

HUS Comprehensive Cancer Center

Helsinki, 00290, Finland

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Medical Director

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: April 8, 2020
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

FI (1)