Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment ovarian stimulation in vitro fertilization cryopreservation
Sponsor New York Medical College
Start date January 2002
End date December 2012
Trial size 100 participants
Trial identifier NCT00504699, 0110005172

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ovarian stimulation after breast cancer diagnosis and before breast cancer treatment
ovarian stimulation in vitro fertilization cryopreservation
Letrozole 5 mg/day during ovarian stimulation
(No Intervention)
No ovarian stimulation before breast cancer treatment
ovarian stimulation in vitro fertilization cryopreservation
Letrozole 5 mg/day during ovarian stimulation

Primary Outcomes

Measure
Breast cancer relapse free survival after ovarian stimulation
time frame: after chemotherapy to end of follow up

Secondary Outcomes

Measure
Estradiol level, number of embryos cryopreserved, clinical pregnancy rate, ovarian reserve after chemotherapy
time frame: during stimulation, after stimulation and 1-2 years after chemotherapy

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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

Additional Information

Official title Safety of Ovarian Stimulation With Letrozole and Gonadotropins in Breast Cancer Patients Undergoing Embryo or Oocyte Cryopreservation: A Prospective Controlled Follow up Study
Principal investigator Kutluk H Oktay, MD, FACOG
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by New York Medical College.