RightFit
RecruitingPhase 3

Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 50 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares tamoxifen and letrozole, each used with hormone shots, to see which helps collect more eggs for freezing before cancer treatment. It is for adults with newly diagnosed breast cancer who have not started chemotherapy and want to save eggs for a possible future pregnancy.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are age 18 or older.
  • Have a new breast cancer diagnosis.
  • Have not started chemotherapy, a drug treatment for cancer.
  • Want to take medicines to help the ovaries make eggs and have the eggs collected before cancer treatment.

Who can't join

  • Have already started or finished chemotherapy.
  • Have breast cancer that has come back and had chemotherapy before.
  • Have stage IV breast cancer, meaning it has spread to distant parts of the body.
  • Your cancer doctor advises against joining. You may still choose letrozole with hormone shots.
  • Do not plan to have eggs grown and collected before diagnosis. This timing is stated differently in the inclusion rules.
  • Have another serious illness or mental health condition that could affect safety, consent, following study rules, follow-up visits, or study results.
  • Are younger than 18.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

CA