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

Sponsor:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00984399

Purpose

The purpose of this study is to see if Vagifem® 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.

Condition	Intervention
Atrophic Vaginitis Breast Cancer	Drug: Vagifem® (vaginal 17β-estradiol)

Study Type:	Interventional
Study Design:	Treatment, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study
Official Title:	Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Estradiol dipropionate BaseLine Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

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 25 µg 17- β estradiol. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the rise in estradiol in women on letrozole vs. anastrozole during treatment with low dose vaginal 25 µg 17- β estradiol to see if there are differences between aromatase inhibitors. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To describe patterns of estradiol and FSH levels over the twenty-four week study period. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To compare the patient's Female Sexual Function Index (FSFI) scores at baseline, week 12 and week 24. [ Time Frame: Week 12 and week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	September 2009
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
vaginal 17β-estradiol: Experimental 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.	Drug: Vagifem® (vaginal 17β-estradiol) The goal is to have 25 patients on letrozole and 25 on anastrozole who are initiated on vaginal estrogen for symptoms of urogenital atrophy. All subjects will receive 25mcg 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 25mcg vaginal 17-β estradiol.

Arms

Assigned Interventions

vaginal 17β-estradiol: Experimental

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.

Drug: Vagifem® (vaginal 17β-estradiol)

The goal is to have 25 patients on letrozole and 25 on anastrozole who are initiated on vaginal estrogen for symptoms of urogenital atrophy. All subjects will receive 25mcg 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 25mcg vaginal 17-β estradiol.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984399

Contacts

Contact: Mercedes Castiel, MD	212-639-5060
Contact: Maura Dickler, MD	646-888-4560

Locations

United States, New Jersey
Memoral Sloan Kettering Cancer Center	Recruiting
Basking Ridge, New Jersey, United States
Contact: Mercedes Castiel, MD
United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Mercedes Castiel, MD
Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital	Recruiting
Sleepy Hollow, New York, United States
Contact: Mercedes Castiel, MD
Memorial Sloan-Kettering at Mercy Medical Center	Recruiting
Rockville Centre, New York, United States
Contact: Mercedes Castiel, MD
Memorial Sloan-Kettering Cancer Center @ Suffolk	Recruiting
Commack, New York, United States, 11725
Contact: Mercedes Castiel, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Mercedes Castiel, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Mercedes Castiel, M.D. )
Study ID Numbers:	09-110
Study First Received:	September 24, 2009
Last Updated:	January 29, 2010
ClinicalTrials.gov Identifier:	NCT00984399 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

vaginitis
Postmenopausal
17-β estradiol
09-110

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Molecular Mechanisms of Pharmacological Action
Contraceptive Agents
Vaginitis
Estradiol valerate
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Vaginal Diseases
Estradiol 17 beta-cypionate
Reproductive Control Agents
Hormones
Genital Diseases, Female
Neoplasms by Site

Estradiol 3-benzoate
Therapeutic Uses
Polyestradiol phosphate
Aromatase Inhibitors
Breast Diseases
Estrogens
Skin Diseases
Breast Neoplasms
Enzyme Inhibitors
Estradiol
Pharmacologic Actions
Neoplasms
Atrophy

ClinicalTrials.gov processed this record on February 08, 2010