Breast CancerNCT00504699
Safety of Ovarian Stimulation With Letrozole and Gonadotropins in Breast Cancer Patients
A study testing Ovarian stimulation in vitro fertilization cryopreservation in people with Breast Cancer, run by New York Medical College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ovarian stimulation in vitro fertilization cryopreservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to 1 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-45 years
- Biopsy proven breast cancer
- No prior chemotherapy or oophorectomy
- Regular menstrual cycles
- Normal basal FSH and estradiol
Who cannot join
- Stage 4 breast cancer
Trial locations and contacts
1 site in 1 country.
About this 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
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
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Ovarian stimulation in vitro fertilization cryopreservation
- Keywords
- breast cancer, ovarian stimulation, aromatase inhibitors, letrozole, fertility preservation, recurrence
- Medical subject headings
- Breast Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovarian stimulation in vitro fertilization cryopreservationProcedure or surgery
Letrozole 5 mg/day during ovarian stimulation
| Study group | Role | What they receive |
|---|---|---|
| letrozole | Experimental | ovarian stimulation after breast cancer diagnosis and before breast cancer treatment Receives: Procedure: Ovarian stimulation in vitro fertilization cryopreservation |
| control | No intervention | No ovarian stimulation before breast cancer treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast cancer relapse free survival after ovarian stimulation
Measured: after chemotherapy to end of follow up
Secondary outcomes (1)
Estradiol level, number of embryos cryopreserved, clinical pregnancy rate, ovarian reserve after chemotherapy
Measured: during stimulation, after stimulation and 1-2 years after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startJan 2002
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Why it stopped: The PI left the Institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kutluk oktay, New York Medical College
- Investigators
- Kutluk H Oktay, MD, FACOG, Principal investigator, IFP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504699
- Sponsor's protocol ID
- 0110005172
- Status last verified
- Mar 2018
- First submitted
- 18 Jul 2007
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26101247Reddy 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.
PubMed 24854484Azim 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.
PubMed 18509175
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00504699
- Acronym / sponsor ID
- 0110005172
- Conditions
- Breast Cancer
- Keywords
- breast cancer, ovarian stimulation, aromatase inhibitors, letrozole, fertility preservation, recurrence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The PI left the Institution.
- Enrolment
- 120 participants (actual)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 20 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| letrozole | Experimental | Procedure: Ovarian stimulation in vitro fertilization cryopreservationovarian stimulation after breast cancer diagnosis and before breast cancer treatment |
| control | No intervention | –No ovarian stimulation before breast cancer treatment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-45 years
- Biopsy proven breast cancer
- No prior chemotherapy or oophorectomy
- Regular menstrual cycles
- Normal basal FSH and estradiol
Key exclusion criteria (1 listed)
- Stage 4 breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ovarian stimulation in vitro fertilization cryopreservationLetrozole 5 mg/day during ovarian stimulation | Procedure or surgery | letrozole |
Primary outcome
Breast cancer relapse free survival after ovarian stimulation
Time frame: after chemotherapy to end of follow up
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: The PI left the Institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Derived from this study: PubMed 26101247Oktay 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.
- Derived from this study: PubMed 24854484Reddy 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.
- Derived from this study: PubMed 18509175Azim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kutluk H Oktay, MD, FACOG principal investigator
IFP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ovarian stimulation in vitro fertilization cryopreservation in people with Breast Cancer, run by New York Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The PI left the Institution.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast cancer relapse free survival after ovarian stimulation (time frame: after chemotherapy to end of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00504699, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.