What side effects are associated with this type of intervention?

Common treatments for breast cancer include tamoxifen, aromatase inhibitors, and local estrogen therapies like Vagifem® 10mcg for vaginal dryness. Tamoxifen can cause hot flashes, disturbed sleep, vaginal dryness, decreased sexual desire, and musculoskeletal symptoms. Aromatase inhibitors, such as anastrozole, are associated with loss of bone density, fractures, and cardiovascular risks. Local estrogen therapies like Vagifem® 10mcg may cause a brief rise in estrogen levels, but their impact on breast cancer outcomes is unclear. These treatments aim to manage symptoms while minimizing adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer, including selective estrogen receptor modulators (SERMs) such as tamoxifen, aromatase inhibitors like letrozole and anastrozole, and targeted therapies like trastuzumab. These treatments aim to reduce estrogen levels or block estrogen receptors to prevent cancer growth. Local estrogen therapies like Vagifem® 10mcg, used for vaginal dryness, are being studied for their safety in breast cancer survivors due to concerns about estrogen absorption and cancer recurrence.

What other types of research exist?

Promising alternatives to Vagifem® 10mcg for treating vaginal dryness in breast cancer patients include non-hormonal moisturizers and lubricants, such as Replens and Hyalo GYN. Additionally, DHEA (prasterone) vaginal inserts, which have a lower systemic absorption, may be considered. Emerging therapies like laser treatments (e.g., MonaLisa Touch) and selective estrogen receptor modulators (SERMs) like ospemifene, which have a different mechanism of action, are also potential options.

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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 who are currently on aromatase inhibitors for at least three months--either letrozole or anastrozole

Must not have

Inability to give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to understand and agree to the study's details.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Estradiol

FDA approved

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Hormonal therapies for breast cancer, such as aromatase inhibitors and selective estrogen receptor modulators (SERMs), work by reducing estrogen levels or blocking estrogen receptors, as estrogen can promote the growth of hormone receptor-positive breast cancer cells. Local estrogen therapies like Vagifem® 10mcg are used to treat vaginal dryness but are generally avoided in breast cancer patients due to concerns about systemic absorption and potential stimulation of breast cancer cells. Understanding these mechanisms helps breast cancer patients and their doctors balance effective cancer treatment with the management of menopausal symptoms.

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Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,944 Previous Clinical Trials

589,721 Total Patients Enrolled

203 Trials studying Breast Cancer

81,526 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

~2 spots leftby Jul 2025

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