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

NCT ID: NCT02890082

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2028-01-31

Brief 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.

Detailed 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Tamoxifen stim in early follicular phase

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

Group Type: EXPERIMENTAL

Tamoxifen stim in early follicular phase

Intervention Type: 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.

Tamoxifen stim in late follicular phase

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

Group Type: OTHER

Tamoxifen stim in late follicular phase

Intervention Type: 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.

Tamoxifen stim in luteal phase

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

Group Type: OTHER

Tamoxifen stim in luteal phase

Intervention Type: 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

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

Hormotherapy; Hormotherapy; Hormotherapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BORDES Virginie, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de l'Ouest

Locations

ICO René Gauducheau

Nantes, , France

Countries

France

Other Identifiers

ICO-N-2013-03

Identifier Type: -

Identifier Source: org_study_id