Clinical trial · Interventional
Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infertility | — | UNRESOLVED | — |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Randomized ER Positive Participants (Letrozole)
- description
- Participants will receive 5 mg of letrozole with the first day of non-investigational gonadotropin (letrozole-gonadotropin) and stopped on the day of oocyte retrieval.
- interventionNames
- Drug: Letrozole
- type
- EXPERIMENTAL
- label
- Randomized ER Positive Participants (Tamoxifen)
- description
- Participants will receive 20 mg of tamoxifen with the first day of non-investigational gonadotropin (tamoxifen-gonadotropin) and stopped on the day of oocyte retrieval
- interventionNames
- Drug: Tamoxifen
- type
- NO_INTERVENTION
- label
- ER Negative (ER-) Participants
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLetourneau J, Juarez-Hernandez F, Wald K, Ribeiro S, Wang A, McCulloch CE, Mok-Lin E, Dolezal M, Chien AJ, Cedars MI, Rosen M. Concomitant tamoxifen or letrozole for optimal oocyte yield during fertility preservation for breast cancer: the TAmoxifen or Letrozole in Estrogen Sensitive tumors (TALES) randomized clinical trial. J Assist Reprod Genet. 2021 Sep;38(9):2455-2463. doi: 10.1007/s10815-021-02273-3. Epub 2021 Jul 26. PMID 34312774