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

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ClinicalTrials.gov Identifier: NCT00504699
Recruitment Status : Terminated (The PI left the Institution.)
First Posted : July 20, 2007
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
kutluk oktay, New York Medical College

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

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Ovarian stimulation in vitro fertilization cryopreservation Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Study Start Date : January 2002
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : March 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Letrozole
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Breast cancer relapse free survival after ovarian stimulation [ Time Frame: after chemotherapy to end of follow up ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: July 20, 2007    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by kutluk oktay, 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
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs