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| Sponsored by: |
New York Medical College |
|---|---|
| Information provided by: | New York Medical College |
| ClinicalTrials.gov Identifier: | NCT00504699 |
Purpose
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
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Procedure: Ovarian stimulation in vitro fertilization cryopreservation |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2002 |
| Estimated Study Completion Date: | January 2012 |
| Arms | Assigned Interventions |
|---|---|
|
letrozole: Experimental
ovarian stimulation after breast cancer diagnosis and before breast cancer treatment
|
Procedure: Ovarian stimulation in vitro fertilization cryopreservation |
|
control: No Intervention
No ovarian stimulation before breast cancer treatment
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kutluk H Oktay, MD, FACOG | 2127464292 | kuo9001@med.cornell.edu |
| United States, New York | |
| Weill Medical College of Cornell University and New York Hospital | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Kutluk H Oktay, MD, FACOG | |
| Principal Investigator: | Kutluk H Oktay, MD, FACOG | Weill-Cornell Medical College |
More Information
| Study ID Numbers: | 0110005172 |
| Study First Received: | July 18, 2007 |
| Last Updated: | February 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00504699 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
breast cancer ovarian stimulation aromatase inhibitors |
letrozole fertility preservation recurrence |
|
Infertility Skin Diseases Breast Neoplasms Letrozole |
Aromatase Inhibitors Breast Diseases Recurrence |
|
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Therapeutic Uses |
Breast Neoplasms Enzyme Inhibitors Letrozole Aromatase Inhibitors Pharmacologic Actions Breast Diseases |
