Recruiting at 1 site Phase 3 Infertility

Infertility study: Tamoxifen vs Letrozole

Official title Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial

ClinicalTrials.gov ID: NCT03011684

What this study is testing

What is Tamoxifen?

This is an investigational oral medicine being studied to help preserve fertility in people with estrogen-receptor-positive breast cancer. It is designed to block estrogen receptors in the body to help stimulate the ovaries to release eggs.

Also referred to as Nolvadex, Soltamox.

Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Researchers want to find out whether letrozole or tamoxifen, each combined with hormones, gives a higher number of eggs that can be frozen for future use.
Who it's for
Women of child‑bearing age who have estrogen‑receptor‑positive breast cancer and want to keep the option of having children later.
What's involved
Participants will receive one of the two drug combinations for ovarian stimulation, then have a minor procedure to retrieve and freeze eggs. They will also have routine blood tests and monitoring visits.
Time commitment
The whole process takes about 2 weeks of daily medication, a few clinic visits for monitoring, and one retrieval appointment.
  • Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 50, women only

You may be able to join 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 likely 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...
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it is enrolling

  • San Francisco, California, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18 years to 50 years. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.