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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by New York Medical College.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
kutluk oktay, New York Medical College
ClinicalTrials.gov Identifier:
NCT00504699
First received: July 18, 2007
Last updated: April 25, 2012
Last verified: April 2012
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by New York Medical College:

Primary Outcome Measures:
  • Breast cancer relapse free survival after ovarian stimulation [ Time Frame: after chemotherapy to end of follow up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2002
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: letrozole
ovarian stimulation after breast cancer diagnosis and before breast cancer treatment
Procedure: Ovarian stimulation in vitro fertilization cryopreservation
Letrozole 5 mg/day during ovarian stimulation
No Intervention: control
No ovarian stimulation before breast cancer treatment
Procedure: Ovarian stimulation in vitro fertilization cryopreservation
Letrozole 5 mg/day during ovarian stimulation

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504699

Locations
United States, New York
IFPn
Valhalla, New York, United States, 10595
Sponsors and Collaborators
New York Medical College
Investigators
Principal Investigator: Kutluk H Oktay, MD, FACOG IFP
  More Information

No publications provided by New York Medical College

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: kutluk oktay, PI, New York Medical College
ClinicalTrials.gov Identifier: NCT00504699     History of Changes
Other Study ID Numbers: 0110005172
Study First Received: July 18, 2007
Last Updated: April 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by New York Medical College:
breast cancer
ovarian stimulation
aromatase inhibitors
letrozole
fertility preservation
recurrence

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Aromatase Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014