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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00504699
• Other study ID #: 0110005172
• Status: Terminated
• Phase: N/A
• First received: July 18, 2007
• Last updated: March 27, 2018
• Start date: January 2002
• Est. completion date: March 1, 2018

Study information

• Verified date: March 2018
• Source: New York Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Ovarian stimulation in vitro fertilization cryopreservation
Letrozole 5 mg/day during ovarian stimulation

Locations

Country	Name	City	State
United States	IFPn	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast cancer relapse free survival after ovarian stimulation		after chemotherapy to end of follow up
Secondary	Estradiol level, number of embryos cryopreserved, clinical pregnancy rate, ovarian reserve after chemotherapy		during stimulation, after stimulation and 1-2 years after chemotherapy