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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00984399
First received: September 24, 2009
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Atrophic Vaginitis
Breast Cancer
Drug: Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist

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

Resource links provided by NLM:


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 10 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 10 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 and menopause quality of life questionnaire at baseline, week 12 and week 24. [ Time Frame: Week 12 and week 24 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2009
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vaginal 17β-estradiol, questionnaire , symptom checklist
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) questionnaire & menopause symptom checklist
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.
Other Names:
  • 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New Jersey
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
United States, New York
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan-Kettering at Mercy Medical Center
Rockville Centre, New York, United States
Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital
Sleepy Hollow, New York, United States
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Mercedes Castiel, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00984399     History of Changes
Other Study ID Numbers: 09-110
Study First Received: September 24, 2009
Last Updated: June 17, 2014
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:
Atrophic Vaginitis
Vaginitis
Breast Neoplasms
Breast Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Skin Diseases
Vaginal Diseases
Aromatase Inhibitors
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Estrogens
Polyestradiol phosphate
Contraceptive Agents
Contraceptive Agents, Female
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014