- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03011684
Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial (TALES)
Study Overview
Detailed Description
Purpose:
Our primary objective is to determine whether concomitant administration of tamoxifen 20 mg oral with gonadotropins (tamoxifen-gonadotropin) versus a starting dose of letrozole 5 mg oral with gonadotropins (letrozole-gonadotropin) will result in a difference in mature oocyte yield during our routine ovarian stimulation protocol for fertility preservation for Estrogen-Receptor-Positive (ER+) breast cancer.
Specific Aims: Each of the following aims will include a primary comparison and secondary comparisons.
Primary aim: The primary aim will be to compare patients with ER+ breast cancer who are treated with letrozole-gonadotropin versus patients with ER+ breast cancer who are treated tamoxifen-gonadotropin with regard to ovarian stimulation outcomes.
Primary comparison:
1) To determine if the assigned stimulation regimen will result in a difference in mature (meiosis II) oocyte yield in patients with breast cancer who undergo ovarian stimulation for fertility preservation.
Secondary comparison:
- To compare estrogen, progesterone, and androgen levels during the ovarian stimulation cycle.
- To compare estrogen, letrozole, and tamoxifen levels in follicular fluid.
- To compare duration of stimulation (days) and total gonadotropin dose (international units of FSH).
- To assess embryo quality, if applicable, on day 3 and day 5 of embryo culture, a measure of the developmental competence of the oocytes.
Experimental comparison:
- To compare clinical pregnancy rates when cryopreserved tissue is eventually utilized among patients from the assigned stimulation regimens. This comparison is labeled experimental because of the remoteness of such an outcome from our present study.
Secondary Aim: We will repeat the above comparisons among patients with ER+ breast cancer who are treated with tamoxifen-gonadotropin versus a prospectively-obtained reference group of patients with Estrogen-Receptor-Negative (ER-) breast cancer who are treated gonadotropin alone. We will then again repeat the above comparisons among patients with ER+ breast cancer who are treated letrozole-gonadotropin versus patients with ER- breast cancer who are treated gonadotropin alone.
Experimental Design and Methods:
Study population:
The target population is reproductive-age women who have been recently diagnosed with ER+ breast cancer and choose to undergo oocyte or embryo cryopreservation prior to chemotherapy treatment. All eligible women will be asked to join the study at their initial University of California, San Francisco (UCSF) fertility preservation consult. Study participants will be recruited from the Reproductive Endocrinology Clinic at University of California, San Francisco Center for Reproductive Health. A consecutive sample with ER- disease will also be recruited at the same type of visit. They will be asked to take part in the gonadotropin only stimulation group, which will be used for a secondary aim.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Rebecca Wong
- Phone Number: 415-353-4305
- Email: Rebecca.Wong@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- Recruiting
- University of California at San Francisco
-
Principal Investigator:
- Mitchell Rosen, M.D.
-
Contact:
- Rebecca Wong
- Phone Number: 415-353-4305
- Email: Rebecca.Wong@ucsf.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- New breast cancer diagnosis
- Has not yet begun chemotherapy
- Desires to undergo ovarian stimulation and oocyte retrieval prior to cancer treatment
- Age 18 years old or greater
Exclusion Criteria:
- Chemotherapy has already commenced or been completed
- History of recurrent breast cancer (with a prior history of chemotherapy)
- Stage IV breast cancer diagnosis (metastases remote from the breast)
- Patient's oncologist advises against the trial - in which case they can choose to receive stimulation with letrozole+gonadotropin
- Does not plan to undergo ovarian stimulation and oocyte retrieval prior to diagnosis
- Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow-up, or interpretation of study results
- Age less than 18 years old
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ER Positive - Letrozole
|
For ER Positive Randomization
|
Experimental: ER Positive - Tamoxifen
|
For ER Positive Randomization
|
No Intervention: ER Negative
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mature Oocyte Yield
Time Frame: Up to 2 weeks
|
To determine if the assigned stimulation regimen will result in a difference in mature (meiosis II) oocyte yield in patients with breast cancer who undergo ovarian stimulation for fertility preservation.
An Effect Size of 3 mature oocytes, based on clinically significant difference of 2 embryos to transfer.
An average of 2 embryos are transferred per freeze-thaw cycle.
If ~75% of mature oocytes will become embryos that can be frozen, then 3 mature oocytes should yield ~2 embryos for transfer.
This effect size would effectively mean an additional event of embryos transferred.
|
Up to 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare change in estrogen levels during the ovarian stimulation cycle
Time Frame: Up to 2 weeks
|
Estrogen level data will be collected at baseline and after completion of the stimulation cycle
|
Up to 2 weeks
|
Compare change in progesterone levels during the ovarian stimulation cycle
Time Frame: Up to 2 weeks
|
Progesterone level data will be collected at baseline and after completion of the stimulation cycle
|
Up to 2 weeks
|
Compare change in androgen levels during the ovarian stimulation cycle
Time Frame: Up to 2 weeks
|
Androgen level data will be collected at baseline and after completion of the stimulation cycle
|
Up to 2 weeks
|
Compare change in estrogen in follicular fluid
Time Frame: Up to 2 weeks
|
Estrogen levels in follicular fluid will be collected at baseline and after completion of the stimulation cycle
|
Up to 2 weeks
|
Compare change in letrozole in follicular fluid
Time Frame: Up to 2 weeks
|
Letrozole levels in follicular fluid will be collected at baseline and after completion of the stimulation cycle
|
Up to 2 weeks
|
Compare change in tamoxifen in follicular fluid
Time Frame: Up to 2 weeks
|
Tamoxifen levels in follicular fluid will be collected at baseline and after completion of the stimulation cycle
|
Up to 2 weeks
|
Compare duration of stimulation (days) and total gonadotropin dose
Time Frame: Up to 2 weeks
|
Up to 2 weeks
|
|
Number if competent oocytes on day 3 of embryo culture
Time Frame: Up to 2 weeks
|
To assess embryo quality, if applicable, on day 3 of embryo culture, a measure of the developmental competence of the oocytes.
|
Up to 2 weeks
|
Number if competent oocytes on day 5 of embryo culture
Time Frame: Up to 2 weeks
|
To assess embryo quality, if applicable, on day 5 of embryo culture, a measure of the developmental competence of the oocytes.
|
Up to 2 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mitchell Rosen, MD, University of California, San Francisco
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Infertility
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Bone Density Conservation Agents
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Letrozole
- Tamoxifen
Other Study ID Numbers
- TALES Trial
- NCI-2017-01809 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))
- 16751 (Other Identifier: University of California, San Francisco)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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