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Vaginal Estrogen for Breast Cancer

N/A
Waitlist Available
Led By Shari Goldfarb, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of breast cancer, stages I-III with pathology confirmed at MSKCC
Women with symptomatic urogenital atrophy: vaginal dryness, irritation, pruritus, dyspareunia, urinary frequency and/or urinary incontinence
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing whether the Vagifem® 10mcg product is safe for women who have had breast cancer.

Who is the study for?
This trial is for postmenopausal women with a history of stages I-III breast cancer, currently on aromatase inhibitors and experiencing vaginal dryness or related symptoms. They must be at least 18, speak English, have had a gynecology exam within six months, completed primary treatment except endocrine therapy, and show no signs of active disease.Check my eligibility
What is being tested?
The study tests if Vagifem® (vaginal estrogen) is safe for women who've had breast cancer. It examines whether the estrogen from Vagifem®, meant to alleviate vaginal dryness, gets absorbed into the bloodstream and affects breast cancer outcomes.See study design
What are the potential side effects?
Potential side effects may include local reactions like irritation or itching in the vagina due to tablet insertion. Since it's unclear how much estrogen is absorbed systemically, there could be an unknown risk of influencing breast cancer recurrence.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had breast cancer stages I-III confirmed by MSKCC.
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I experience symptoms like vaginal dryness, irritation, or urinary issues.
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I am menopausal, either naturally, through surgery, or due to chemotherapy.
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I have been taking aromatase inhibitors for at least three months.
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I experience symptoms like vaginal dryness, irritation, or urinary issues.
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I am 18 years old or older.
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I am a woman who has finished all primary cancer treatments except hormone therapy and currently show no signs of the disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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 patient's Female Sexual Function Index (FSFI) scores and menopause quality of life questionnaire at baseline, week 12 and week 24.
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.

Trial Design

1Treatment groups
Experimental Treatment
Group I: vaginal 17β-estradiol, questionnaire , symptom checklistExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,931 Previous Clinical Trials
597,659 Total Patients Enrolled
202 Trials studying Breast Cancer
95,139 Patients Enrolled for Breast Cancer
Shari Goldfarb, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
8 Previous Clinical Trials
1,438 Total Patients Enrolled
7 Trials studying Breast Cancer
1,388 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the size of the patient population being evaluated in this research project?

"At present, no new patients are being recruited for this trial. The original posting date was September 1st 2009 and the last update occurred on October 18th 2022. Further research can be done to locate other clinical studies; as of now, 2610 trials involving breast cancer sufferers need participants while 50 studies investigating Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist have open spots available."

Answered by AI

Have there been any other surveys utilizing Vagifem® (vaginal 17β-estradiol) and a menopause symptom inventory?

"First trialled in the year 1996 at National Institutes of Health Clinical Center, Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist has been subject to 211 studies as of today. At present, 50 live studies are being conducted with numerous trials taking place in Basking Ridge, New jersey."

Answered by AI

What afflictions can be treated by administering Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist?

"Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist are often implemented to treat amenorrhea in the prior 6 months. Additionally, this combination of tests can be advantageous for addressing hypoestrogenism, vasomotor symptoms related to menopausal transitions, and breast issues."

Answered by AI

What is the current count of medical facilities implementing this trial?

"Seven medical sites are currently enrolling participants in this trial, including Memorial Sloan Kettering Cancer Center in Basking Ridge, Memorial Sloan Kettering Cancer Center@Phelps Memorial Hospital in Sleepy Hollow, and Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital in Rockville Centre. Additionally there is recruitment at four other locations."

Answered by AI

Are participants being enrolled in this experiment currently?

"At present, this study is not searching for patients. It was posted on September 1st 2009 and updated recently in October 18th 2022. If you're seeking other trials, 2610 clinical studies are currently enrolling breast cancer patients while 50 different research projects require participants to answer a Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist."

Answered by AI
~1 spots leftby Sep 2024