RECRUITING

Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial

Quick Facts

Study Start:2016-07-21
Study Completion:2025-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03011684

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * New breast cancer diagnosis
  2. * Has not yet begun chemotherapy
  3. * Desires to undergo ovarian stimulation and oocyte retrieval prior to cancer treatment
  4. * Age 18 years old or greater
  1. * Chemotherapy has already commenced or been completed
  2. * History of recurrent breast cancer (with a prior history of chemotherapy)
  3. * Stage IV breast cancer diagnosis (metastases remote from the breast)
  4. * Patient's oncologist advises against the trial - in which case they can choose to receive stimulation with letrozole+gonadotropin
  5. * Does not plan to undergo ovarian stimulation and oocyte retrieval prior to diagnosis
  6. * 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
  7. * Age less than 18 years old

Contacts and Locations

Study Contact

Rebecca Wong
CONTACT
415-353-4305
Rebecca.Wong@ucsf.edu

Principal Investigator

Mitchell Rosen, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California at San Francisco
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Mitchell Rosen, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-07-21
Study Completion Date2025-01-31

Study Record Updates

Study Start Date2016-07-21
Study Completion Date2025-01-31

Terms related to this study

Keywords Provided by Researchers

  • Fertility Preservation
  • Breast Cancer

Additional Relevant MeSH Terms

  • Infertility