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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00504699
Enrollment
120
Registered
2007-07-20
Start date
2002-01-31
Completion date
2018-03-01
Last updated
2018-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, ovarian stimulation, aromatase inhibitors, letrozole, fertility preservation, recurrence

Brief 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

Detailed 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.

Interventions

PROCEDUREOvarian stimulation in vitro fertilization cryopreservation

Letrozole 5 mg/day during ovarian stimulation

Sponsors

New York Medical College
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Breast cancer relapse free survival after ovarian stimulationafter chemotherapy to end of follow up

Secondary

MeasureTime frame
Estradiol level, number of embryos cryopreserved, clinical pregnancy rate, ovarian reserve after chemotherapyduring stimulation, after stimulation and 1-2 years after chemotherapy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026