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


N/A
18 Years
45 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Breast cancer relapse free survival after ovarian stimulation

Outcome Time Frame:

after chemotherapy to end of follow up

Safety Issue:

Yes

Principal Investigator

Kutluk H Oktay, MD, FACOG

Investigator Role:

Principal Investigator

Investigator Affiliation:

IFP

Authority:

United States: Institutional Review Board

Study ID:

0110005172

NCT ID:

NCT00504699

Start Date:

January 2002

Completion Date:

January 2013

Related Keywords:

  • Breast Cancer
  • breast cancer
  • ovarian stimulation
  • aromatase inhibitors
  • letrozole
  • fertility preservation
  • recurrence
  • Breast Neoplasms

Name

Location

IFPnValhalla, New York  10595