Fertility preservation for breast cancer patients using tamoxifen or letrozole
Official title: Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial
Run by University of California, San Francisco · NCT03011684 · Data updated 2026-11-12
This study is testing whether tamoxifen or letrozole works better with fertility drugs to help women with breast cancer save their eggs before treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 309 (estimated) |
| Sponsor | University of California, San Francisco Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (San Francisco, California) |
| Status | Recruiting |
| Started | July 21, 2016 |
| Main results expected | March 31, 2028 |
| Study ends | March 31, 2028 |
| Registry record updated | June 4, 2026 |
| Trial ID | NCT03011684 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 and older with a new diagnosis of estrogen-receptor-positive breast cancer who have not yet started chemotherapy and wish to undergo ovarian stimulation.
✕Probably not a fit
Patients who have already begun chemotherapy, have a history of recurrent breast cancer, or have stage IV breast cancer are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial aims to compare the effectiveness of tamoxifen and letrozole in conjunction with gonadotropins for ovarian stimulation in women with estrogen-receptor-positive breast cancer who wish to preserve their fertility before undergoing cancer treatment. The primary objective is to determine which regimen results in a higher yield of mature oocytes during the stimulation process. Secondary aims include evaluating hormone levels and embryo quality during the ovarian stimulation cycle. The study is designed to improve the quality of life for reproductive-age cancer survivors by enhancing fertility preservation options.
Why it matters
Potential benefit: If successful, this study could significantly improve fertility preservation outcomes for women diagnosed with breast cancer.
How similar studies have gone: Other studies have shown promising results with similar approaches to fertility preservation in breast cancer patients, indicating that this method is not entirely novel but still holds significant potential.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University of California at San Francisco
San Francisco, California, United States Recruiting
Study contacts
- Principal investigator: Mitchell Rosen, MD — University of California, San Francisco
- Study coordinator: Rebecca Wong
- Email: Rebecca.Wong@ucsf.edu
- Phone: 415-353-4305
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.