Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial

ConditionInfertility
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tamoxifen

    Drug

    Given orally

  • Letrozole

    Drug

    Given orally

Treatment groups

309 Participants
are divided into 3 treatment groups
Group A: Randomized ER Positive Participants (Letrozole)Experimental treatment 1 intervention
Group B: Randomized ER Positive Participants (Tamoxifen)Experimental treatment 1 intervention
Group C: ER Negative (ER-) ParticipantsNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Mature Oocyte Yield

To determine if the assigned stimulation regimen will result in a difference in mature (meiosis II) oocyte yield in patients with breast cancer who undergo ovarian stimulation for fertility preservation. An Effect Size of 3 mature oocytes, based on clinically significant difference of 2 embryos to transfer. An average of 2 embryos are transferred per freeze-thaw cycle. If \~75% of mature oocytes will become embryos that can be frozen, then 3 mature oocytes should yield \~2 embryos for transfer. This effect size would effectively mean an additional event of embryos transferred.

Time frame
Up to 2 weeks

Secondary outcomes

1

Compare change in estrogen levels during the ovarian stimulation cycle

Estrogen level data will be collected at baseline and after completion of the stimulation cycle

Time frame
Up to 2 weeks
2

Compare change in progesterone levels during the ovarian stimulation cycle

Progesterone level data will be collected at baseline and after completion of the stimulation cycle

Time frame
Up to 2 weeks
3

Compare change in androgen levels during the ovarian stimulation cycle

Androgen level data will be collected at baseline and after completion of the stimulation cycle

Time frame
Up to 2 weeks
4

Compare change in estrogen in follicular fluid

Estrogen levels in follicular fluid will be collected at baseline and after completion of the stimulation cycle

Time frame
Up to 2 weeks

Other outcomes

Sponsors and contacts

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