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NCT Number: NCT02890082

Preservation of Fertility by Ovarian Stimulation Associated With Tamoxifen, Prior Chemotherapy for Breast Cancer

The rates of patients with spontaneous pregnancies reported after breast cancer is between 3 and 7%, particularly because of these treatments.

Therefore, it is essential to anticipate this problem by proposing the use of fertility preservation techniques for these young patients prior to any gonadotoxic treatment.

PRESAGE study offers to patients fewer than 40, to preserve their fertility before neoadjuvant or adjuvant chemotherapy for invasive breast cancer.

The aim of this study is to evaluate the feasibility of ovarian stimulation emergency order not to delay the start of treatment. This stimulation combined gonadotropin and tamoxifen followed by an oocyte retrieval. The patient may receive an oocyte vitrification and / or embryonic.

This procedure is already done in many countries, and by some French teams, by combining tamoxifen or letrozole to the classic gonadotropin stimulation.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

ICO René Gauducheau

Nantes, 44805, France

About this study

With 50 000 new cases per year, breast cancer is the most common cancer in women in France. About a quarter of breast cancers occurs before menopause and 7% before the age of 40 years. Due to the increased incidence of breast cancer in young women and declining age of first pregnancy, it is not unusual to have patient desiring pregnancy after treatment of a breast cancer. Among these women, the use of adjuvant therapy (chemotherapy, hormone therapy, chemical castration) is common. Adjuvant or neoadjuvant chemotherapy resulted in significantly lower recurrence rates and increase the survival of these patients, but these treatments could have more or less long-term consequences, including in ovarian function. Ovarian consequences of these therapeutic must also be explained to young patients. But it seems that this information is often inadequate or poorly understood, and then patients deplore to be faced with secondary infertility.

The rates of patients with spontaneous pregnancies reported after breast cancer is between 3 and 7%, particularly because of these treatments.

Therefore, it is essential to anticipate this problem by proposing the use of fertility preservation techniques for these young patients prior to any gonadotoxic treatment.

PRESAGE study offers to patients fewer than 40, to preserve their fertility before neoadjuvant or adjuvant chemotherapy for invasive breast cancer.

The aim of this study is to evaluate the feasibility of ovarian stimulation emergency order not to delay the start of treatment. This stimulation combined gonadotropin and tamoxifen followed by an oocyte retrieval. The patient may receive an oocyte vitrification and / or embryonic.

This procedure is already done in many countries, and by some French teams, by combining tamoxifen or letrozole to the classic gonadotropin stimulation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 18 and 40
  • infiltrating breast carcinoma histologically proven
  • Indication of adjuvant or neoadjuvant chemotherapy
  • T0-T1-T2-T3
  • N0-N1-N2a
  • M0 after staging
  • AMH ≥1 ng / mL and / or account antral follicles ≥ 5
  • HIV serology negative.

Exclusion criteria

  • breast cancer history
  • History of another cancer in the last 5 years, with the exception of basal cell skin cancer and squamous cell
  • patient in pregnancy
  • pulmonary embolism under 6 months
  • deep vein thrombosis of less than 6 months.

Treatment and study plan

Tamoxifen stim in early follicular phase

Drug

Day cycle of the patient when ovarian stimulation begin (early follicular phase) = D1 to D3

  • Stimulation with simultaneously: TAM (tamoxifen) 60mg / day + FSH® 150 to 300 IU / day (following ovarian reserve)
  • Monitoring (ultrasound + blood test E2, LH (luteinizing hormone) and P) every 2 to 3 days +/- dose adjustment of FSH
  • Ovulation by blocking the GnRH antagonist (gonadotropin-releasing hormone : CETROTIDE) introduced according to the usual criteria,
  • Continued monitoring (ultrasound + blood test E2, LH and P) every 2 to 3 days
  • Triggering ovulation by OVITRELLE ® 250μg according to the usual criteria
  • 35 h after the onset, oocyte puncture transvaginally the gynecology unit under local or general anesthesia.

Other names: Hormotherapy

Tamoxifen stim in late follicular phase

Drug

Day cycle of the patient when ovarian stimulation begin (late follicular phase) = D4 to D14

  • Monitoring (ultrasound + blood test E2, LH and P) until a follicle of 15 mm
  • Ovulation induction by OVITRELLE® 250μg.
  • Continued monitoring (ultrasound + blood test E2, LH and P) 4 days after OVITRELLE® to the proper stage for the beginning of stimulation.
  • Stimulation with simultaneously: TAM 60mg / day + FSH® 150 to 300 IU / day (following ovarian reserve) + CETROTIDE
  • Continued monitoring (ultrasound + blood test E2, LH and P) every 2 to 3 days +/- adaptation of FSH
  • Triggering ovulation by OVITRELLE ® 250μg according to the usual criteria
  • 35 h after the onset, oocyte puncture transvaginally the gynecology unit under local or general anesthesia.

Other names: Hormotherapy

Tamoxifen stim in luteal phase

Drug

Day cycle of the patient when ovarian stimulation begin (luteal phase) = D15 to D28

  • 1 or 2 Monitoring (ultrasound + blood test E2, LH and P) to check the validity of the post-ovulatory phase
  • Stimulation with simultaneously: TAM 60mg / day + FSH® 150 to 300 IU / day (following ovarian reserve) + CETROTIDE
  • Continued monitoring (ultrasound + blood test E2, LH and P) every 2 to 3 days +/- adaptation of FSH
  • Triggering ovulation by OVITRELLE ® 250μg according to the usual criteria
  • 35 h after the onset, oocyte puncture transvaginally the gynecology unit under local or general anesthesia

Other names: Hormotherapy

Primary outcomes

  1. Assess the feasibility of ovarian stimulation combining tamoxifen with recombinant FSH (follicle stimulating hormone ) followed by oocyte vitrification and / or embryo freezing before chemotherapy for breast cancer.

    Time frame: max 1 month after beginning of stimulation (At the end of oocyte puncture after ovarian stimulation)

    Assess the feasibility of ovarian stimulation combining tamoxifen with recombinant FSH (follicle stimulating hormone ) followed by oocyte vitrification and / or embryo freezing before chemotherapy for breast cancer.

    => evaluated by number of oocytes and / or embryos per patient.

Secondary outcomes

  1. number of pregnancy obtain

    Time frame: At least 2 years After chemotherapy

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Official study title

Pilot Study of Preservation of Fertility by Ovarian Stimulation Associated With Tamoxifen, and Freezing Oocyte or Embryo Prior Chemotherapy for Breast Cancer

Acronym: PRESAGE

Important dates

Study start
2014
Primary completion
2017
Study completion
2028
First posted
Sep 7, 2016
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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