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Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen

Primary Purpose

Atrophic Vaginitis, Breast Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophic Vaginitis focused on measuring vaginitis, Postmenopausal, 17-β estradiol, 09-110

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • History of breast cancer, stages I-III with pathology confirmed at MSKCC
  • Women who have completed all of their primary treatment (surgery, radiation therapy, adjuvant chemotherapy) with the exception of endocrine therapy and currently have no clinical evidence of disease.
  • Women who are currently on aromatase inhibitors for at least three months--either letrozole or anastrozole
  • Women with symptomatic urogenital atrophy: vaginal dryness, irritation, pruritus, dyspareunia, urinary frequency and/or urinary incontinence

  • Menopausal at study entry defined as:

    • Bilateral salpingo-oophorectomy independent of age
    • If natural menopause, age ≥ 50 with cessation of menses for at least 12 months
    • If menopause induced by chemotherapy, age ≥ 50 with no menstrual period at least 12 months after chemotherapy finished
  • At least 18 years of age
  • Able to participate in the informed consent process
  • Gynecology examination within six months
  • Able to read/speak English

Exclusion Criteria:

  • Inability to give informed consent
  • Vaginal bleeding of unknown etiology within 12 months of study entry
  • History of prior vaginal 17-β estradiol or other topical estrogen use within the past six months

Sites / Locations

  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Cancer Center @ Suffolk
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering at Mercy Medical Center
  • Memorial Sloan Kettering Cancer Center@Phelps Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

vaginal 17β-estradiol, questionnaire , symptom checklist

Arm Description

This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.

Outcomes

Primary Outcome Measures

To determine the change in estradiol and follicle stimulating hormone (FSH) from baseline to twelve weeks in postmenopausal women receiving adjuvant aromatase inhibitors during treatment with low dose vaginal 10 µg 17- β estradiol.

Secondary Outcome Measures

To compare the rise in estradiol in women on letrozole vs. anastrozole during treatment with low dose vaginal 10 µg 17- β estradiol to see if there are differences between aromatase inhibitors.
To describe patterns of estradiol and FSH levels over the twenty-four week study period.
To compare the patient's Female Sexual Function Index (FSFI) scores and menopause quality of life questionnaire at baseline, week 12 and week 24.

Full Information

First Posted
September 24, 2009
Last Updated
October 18, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00984399
Brief Title
Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen
Official Title
Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2009 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to see if Vagifem® 10mcg is safe for women who have had breast cancer. Vagifem is an estrogen product. It is a tiny tablet that is inserted into the vagina. It relieves vaginal dryness. Women who have had breast cancer are usually told not to take estrogen. This is because estrogen use can lead to a breast cancer recurrence or a new primary breast cancer. It is unclear if the estrogen in Vagifem is only absorbed in the vagina. It may be absorbed into the blood stream for a short time and may cause a brief rise in your estrogen level. However, there is no clear evidence that this would cause any bad effects in patients with breast cancer. How much, if any, of these topical estrogens are absorbed through the vagina is not known. We also do not know what the impact is of low dose estrogen absorption on breast cancer outcomes. Also, the absorption should decrease as the mucus membranes are restored after estrogen exposure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Vaginitis, Breast Cancer
Keywords
vaginitis, Postmenopausal, 17-β estradiol, 09-110

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vaginal 17β-estradiol, questionnaire , symptom checklist
Arm Type
Experimental
Arm Description
This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.
Intervention Type
Drug
Intervention Name(s)
Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist
Other Intervention Name(s)
The bloodwork will take less than one hour to perform and will be drawn +/- 72hrs from the date the, patient is due for bloodwork.Baseline bloodwork will be drawn within 14 days of study enrollment prior to the initiation of vaginal 25μg 17- β estradiol., Patients will be encouraged to come for their research bloodwork 12-24 hours after the insertion of the vaginal 25μg 17- β estradiol tablets., Patients will record in their diary the time of their last vaginal 10μg 17- β estradiol, tablet insertion. Since we do not know the clinical significance of transient, estradiol elevation in these patients, both the patients and the investigators, will be blinded to the results of these assays for the 24 weeks of study, therapy. We will administer the FSFI survey questionnaire and menopause symptom, checklist at baseline, week 12 and week 24.
Intervention Description
The goal is to have 30 patients on letrozole and 30 on anastrozole who are initiated on vaginal estrogen for symptoms of urogenital atrophy. All subjects will receive 10mcg vaginal 17-β estradiol tablets. Each subject will serve as her own control. We will monitor serum estradiol and follicle stimulating hormone (FSH) levels closely from 0-24 weeks. We will measure serum estradiol and FSH levels at baseline, and subsequently at weeks 2, 7, 12, 18 and 24 after commencing therapy with 10mcg vaginal 17-β estradiol.
Primary Outcome Measure Information:
Title
To determine the change in estradiol and follicle stimulating hormone (FSH) from baseline to twelve weeks in postmenopausal women receiving adjuvant aromatase inhibitors during treatment with low dose vaginal 10 µg 17- β estradiol.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To compare the rise in estradiol in women on letrozole vs. anastrozole during treatment with low dose vaginal 10 µg 17- β estradiol to see if there are differences between aromatase inhibitors.
Time Frame
2 years
Title
To describe patterns of estradiol and FSH levels over the twenty-four week study period.
Time Frame
24 weeks
Title
To compare the patient's Female Sexual Function Index (FSFI) scores and menopause quality of life questionnaire at baseline, week 12 and week 24.
Time Frame
Week 12 and week 24

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of breast cancer, stages I-III with pathology confirmed at MSKCC Women who have completed all of their primary treatment (surgery, radiation therapy, adjuvant chemotherapy) with the exception of endocrine therapy and currently have no clinical evidence of disease. Women who are currently on aromatase inhibitors for at least three months--either letrozole or anastrozole Women with symptomatic urogenital atrophy: vaginal dryness, irritation, pruritus, dyspareunia, urinary frequency and/or urinary incontinence Menopausal at study entry defined as: Bilateral salpingo-oophorectomy independent of age If natural menopause, age ≥ 50 with cessation of menses for at least 12 months If menopause induced by chemotherapy, age ≥ 50 with no menstrual period at least 12 months after chemotherapy finished At least 18 years of age Able to participate in the informed consent process Gynecology examination within six months Able to read/speak English Exclusion Criteria: Inability to give informed consent Vaginal bleeding of unknown etiology within 12 months of study entry History of prior vaginal 17-β estradiol or other topical estrogen use within the past six months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shari Goldfarb, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
Basking Ridge
State/Province
New Jersey
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center @ Suffolk
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering at Mercy Medical Center
City
Rockville Centre
State/Province
New York
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center@Phelps Memorial Hospital
City
Sleepy Hollow
State/Province
New York
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

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Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen

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