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

NCT ID: NCT00504699

Last Updated: 2018-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2018-03-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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letrozole

ovarian stimulation after breast cancer diagnosis and before breast cancer treatment

Group Type EXPERIMENTAL

Ovarian stimulation in vitro fertilization cryopreservation

Intervention Type PROCEDURE

Letrozole 5 mg/day during ovarian stimulation

control

No ovarian stimulation before breast cancer treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ovarian stimulation in vitro fertilization cryopreservation

Letrozole 5 mg/day during ovarian stimulation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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New York Medical College

OTHER

Sponsor Role lead

Responsible Party

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kutluk oktay

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kutluk H Oktay, MD, FACOG

Role: PRINCIPAL_INVESTIGATOR

IFP

Locations

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IFPn

Valhalla, New York, United States

Site Status

Countries

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United States

References

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Oktay K, Turan V, Bedoschi G, Pacheco FS, Moy F. Fertility Preservation Success Subsequent to Concurrent Aromatase Inhibitor Treatment and Ovarian Stimulation in Women With Breast Cancer. J Clin Oncol. 2015 Aug 1;33(22):2424-9. doi: 10.1200/JCO.2014.59.3723. Epub 2015 Jun 22.

Reference Type DERIVED
PMID: 26101247 (View on PubMed)

Reddy J, Turan V, Bedoschi G, Moy F, Oktay K. Triggering final oocyte maturation with gonadotropin-releasing hormone agonist (GnRHa) versus human chorionic gonadotropin (hCG) in breast cancer patients undergoing fertility preservation: an extended experience. J Assist Reprod Genet. 2014 Jul;31(7):927-32. doi: 10.1007/s10815-014-0248-6. Epub 2014 May 23.

Reference Type DERIVED
PMID: 24854484 (View on PubMed)

Azim AA, Costantini-Ferrando M, Oktay K. Safety of fertility preservation by ovarian stimulation with letrozole and gonadotropins in patients with breast cancer: a prospective controlled study. J Clin Oncol. 2008 Jun 1;26(16):2630-5. doi: 10.1200/JCO.2007.14.8700.

Reference Type DERIVED
PMID: 18509175 (View on PubMed)

Other Identifiers

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0110005172

Identifier Type: -

Identifier Source: org_study_id

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