Safety of Ovarian Stimulation With Letrozole and Gonadotropins in Breast Cancer Patients

Study Overview
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Brief Summary
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Breast cancer patients are commonly treated with drugs that eggs present in the ovary and may reduce their chance for getting pregnant. Their fertility can be preserved by stimulating their ovaries, collecting multiple eggs, fertilize them in the lab and freeze them. Ovarian stimulation increase their estrogen levels in blood.this may stimulate their cancer and increase chance for recurrence. If a medicine that prevent estrogen rise is used (letrozole), this may increase the safety of stimulation. In this study we compared ovarian stimulation in breast cancer patients using letrozole with those who did not undergo stimulation and showed that there is no increase risk for recurrence after a median follow up of 2 years

Detailed Description
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215 women with breast cancer were evaluated for fertility preservation before chemotherapy. Of those, 79 elected to undergo controlled ovarian stimulation (COH) with letrozole and gonadotropins for embryo or oocyte cryopreservation. The 136 patients who declined served as controls.There were no significant differences between the study and control groups regarding age at diagnosis, breast cancer prognostic parameters (tumor size, grade, number of positive lymph nodes, estrogen receptor status, her2-neu overexpression and vascular space invasion), and chemotherapy regimens. There was no difference between the two groups in the projected 10 year relapse, breast cancer specific mortality or overall mortality. There were 3 recurrences or contralateral breast cancers (2 distant, 1 locoregional) in the letrozole group, and 11 in the control group (9 distant, 1 locoregional, 1 contralateral breast). Comparison; breast cancer patients that underwent ovarian stimulation with letrozole+gonadotropins and those who declined ovarian stimulation.

Official Title
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Safety of Ovarian Stimulation With Letrozole and Gonadotropins in Breast Cancer Patients Undergoing Embryo or Oocyte Cryopreservation: A Prospective Controlled Follow up Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Ovarian stimulation in vitro fertilization cryopreservation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-45 years Biopsy proven breast cancer No prior chemotherapy or oophorectomy Regular menstrual cycles Normal basal FSH and estradiol Exclusion Criteria: Stage 4 breast cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: letrozole<br>ovarian stimulation after breast cancer diagnosis and before breast cancer treatment | Procedure: Ovarian stimulation in vitro fertilization cryopreservation<br>* Letrozole 5 mg/day during ovarian stimulation<br>|
| No Intervention: control<br>No ovarian stimulation before breast cancer treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast cancer relapse free survival after ovarian stimulation |  | after chemotherapy to end of follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estradiol level, number of embryos cryopreserved, clinical pregnancy rate, ovarian reserve after chemotherapy |  | during stimulation, after stimulation and 1-2 years after chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, ovarian stimulation, aromatase inhibitors, letrozole, fertility preservation, recurrence