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Study of Fertility Preservation Using Tamoxifen, Follitropin Beta, Cetrorelix and Choriogonadotropin Alfa in Women with Breast Cancer Before Chemotherapy

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on preserving fertility in women with breast cancer who need to undergo chemotherapy. The research aims to evaluate a method of preserving fertility through ovarian stimulation before starting cancer treatment. The study combines two medications: Tamoxifen (taken as tablets) and follitropin beta (given as an injection under the skin).

During the study, participants will receive additional medications including cetrorelix and choriogonadotropin alfa, which help control the timing of egg development and maturation. These medications are administered through injections under the skin. The ovarian stimulation process is performed to collect and preserve eggs or embryos before starting chemotherapy treatment.

The treatment involves taking medications for approximately 12 days to stimulate the ovaries to produce multiple eggs. Once the eggs have matured, they are collected and frozen for future use. This process allows women to preserve their fertility options before starting their cancer treatment. The study will monitor the number of eggs or embryos obtained and track pregnancy outcomes in the future.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your fertility potential will be evaluated through blood tests measuring AMH hormone (must be ≥1 ng/mL)

    An ultrasound examination will count your antral follicles (must be ≥5)

    HIV testing will be performed to confirm negative status

  2. Step 2

    Ovarian stimulation start

    You will begin taking Tamoxifen (Nolvadex) tablets - 10 mg orally

    You will receive Puregon (follitropin beta) - 300 IU through subcutaneous injection

    Regular monitoring of your ovarian response will be conducted through blood tests and ultrasound examinations

  3. Step 3

    Prevention of early ovulation

    You will receive Cetrotide (cetrorelix) - 0.25 mg through subcutaneous injection to prevent premature ovulation

  4. Step 4

    Triggering ovulation

    When your follicles reach appropriate size, you will receive Ovitrelle (choriogonadotropin alfa) - 250 micrograms through subcutaneous injection to trigger final egg maturation

  5. Step 5

    Egg retrieval and preservation

    Your mature eggs will be collected through a minor surgical procedure

    The retrieved eggs will be preserved through freezing (vitrification)

    If applicable, embryo freezing may be performed

  6. Step 6

    Chemotherapy initiation

    Your planned chemotherapy treatment will begin following completion of the fertility preservation procedure

  7. Step 7

    Long-term follow-up

    Your health status will be monitored for up to 10 years

    Any resulting pregnancies will be documented

Who can join the trial?

11 criteria

  • Must provide signed informed consent before starting any study procedures
  • Must be female between 18 and 40 years old
  • Must have confirmed invasive breast cancer proven by tissue examination
  • Must be scheduled to receive chemotherapy either before or after surgery, as confirmed by medical team
  • Cancer must be classified as T0-T3 (referring to tumor size and extent)
  • Lymph node status must be N0-N2a (indicating the extent of cancer spread to nearby lymph nodes)
  • Must have no distant spread of cancer to other parts of the body (M0 status)
  • Must have adequate ovarian function shown by either:
    • AMH level (a hormone that indicates egg supply) of 1 ng/mL or higher
    • Antral follicle count (number of potential egg-containing follicles) of 5 or more visible on ultrasound
    • Must test negative for HIV
    • Must have social protection (health insurance or coverage)

Who cannot join the trial?

14 criteria

  • Previous treatment with chemotherapy (medications used to treat cancer)
  • Age below 18 or above 45 years
  • Male patients (study is for females only)
  • Previous fertility preservation procedures
  • Presence of other types of cancer besides breast cancer
  • Known allergies to Tamoxifen or FSH (fertility hormones used in the study)
  • Currently pregnant or breastfeeding
  • Severe medical conditions that could interfere with fertility treatment
  • Inability to undergo oocyte retrieval (egg collection procedure)
  • Contraindications to hormonal stimulation
  • History of blood clotting disorders
  • Active infections or serious illnesses that could affect treatment safety
  • Mental conditions that could affect ability to provide informed consent
  • Participation in other clinical trials within the past 30 days
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Investigated drugs

Tamoxifen is a medication commonly used in breast cancer treatment. It works by blocking the effects of estrogen in breast tissue, which can help prevent breast cancer cells from growing. In this trial, it is being used as part of a fertility preservation strategy. Recombinant FSH (Follicle Stimulating Hormone) is a hormone medication that stimulates the ovaries to produce multiple eggs. It is commonly used in fertility treatments to help women produce more eggs during a single cycle. In this trial, it is being combined with Tamoxifen to help preserve fertility before chemotherapy treatment. Oocyte vitrification is a rapid freezing technique used to preserve a woman's eggs. This is not a medication but rather a laboratory procedure that allows unfertilized eggs to be stored for future use. Embryo freezing is another preservation technique where fertilized eggs (embryos) are frozen for future use. Like vitrification, this is a procedure rather than a medication.

What is already known about the treatment

  • Tamoxifen

    An oral medication that belongs to a class of drugs known as selective estrogen receptor modulators (SERMs), primarily used in the treatment and prevention of breast cancer. The drug works by blocking estrogen receptors in breast tissue, effectively preventing estrogen from stimulating the growth of hormone-receptor-positive breast cancer cells. In this clinical trial, Tamoxifen is being studied in combination with recombinant FSH (follicle-stimulating hormone) for ovarian stimulation to preserve fertility in breast cancer patients before they undergo chemotherapy.

  • Recombinant FSH

    A synthetic form of follicle-stimulating hormone that is administered via subcutaneous injection to stimulate the development of ovarian follicles. This medication is commonly used in fertility treatments and assists in the production of mature eggs that can be retrieved for preservation through vitrification or for creating embryos that can be frozen for future use. In this context, it is being studied alongside Tamoxifen as part of a fertility preservation protocol for breast cancer patients prior to their chemotherapy treatment.

Investigated diseases

Breast cancer – A disease that begins when cells in the breast start to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The cancer starts in the cells of the breast, typically either in the ducts that carry milk or the glands that make milk. It occurs when breast cells begin to grow abnormally, dividing more rapidly than healthy cells. These cells can spread through the breast to the lymph nodes and to other parts of the body. The disease can affect both women and men, though it's much more common in women.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516282-37-00Protocol codeICO-N-2013-03Estimated enrolment100 patientsSponsorInstitut De Cancerologie De L Ouest

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