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

Breast Cancer Clinical Trial

— PRESAGE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02890082
• Other study ID #: ICO-N-2013-03
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 2014
• Est. completion date: July 2024

Study information

• Verified date: July 2023
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: July 2024
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Tamoxifen stim in early follicular phase
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.
• Tamoxifen stim in late follicular phase
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.
• Tamoxifen stim in luteal phase
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

Locations

Country	Name	City	State
France	ICO René Gauducheau	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	max 1 month after beginning of stimulation (At the end of oocyte puncture after ovarian stimulation)
Secondary	number of pregnancy obtain		At least 2 years After chemotherapy