What this study is
Latrogenic infertility as a result of cancer treatment has a profound effect on long-term quality of life in survivors of reproductive-age cancers. Oocyte cryopreservation prior to cancer treatment has been associated with improved quality of life, with a potential ability to reduce long-term decision-related regret in cancer survivors. Though letrozole plus gonadotropin and and tamoxifen plus gonadotropin are currently routinely used worldwide in ovarian stimulation cycles for fertility preservation in patients with estrogen-receptor-positive breast cancer, it is not clear which of the two might lead to improved oocyte yield. Improved knowledge about the efficacy of these medications, with regard to oocyte yield, has the potential to significantly improve quality of life in reproductive-age breast cancer survivors.
What's being tested
- Tamoxifen
Intervention · DRUG
- Letrozole
Intervention · DRUG
Both interventions
Given orally
Study details
- Sponsor
- University of California, San Francisco
- Conditions
- Infertility
- Enrolling
- 309 people
- Starts
- 2016-07-21
- Est. completion
- 2028-03-31
- Design
- Open-label, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 50 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of California at San Francisco
San Francisco, California, United States
- Rebecca Wong · Contact415-353-4305Rebecca.Wong@ucsf.edu
- Mitchell Rosen, M.D. · Principal investigator
Recruiting
Study team
Sponsor
University of California, San Francisco
Study ID TALES Trial
Principal investigator
Mitchell Rosen, MD
University of California, San Francisco
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.