Clinical trial

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

Name

ICO-N-2013-03

Description

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.

Trial arms

Trial start

2014-02-01

Estimated PCD

2017-07-01

Trial end

2024-07-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

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.

Arms:

Tamoxifen stim in early follicular phase

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.

Arms:

Tamoxifen stim in late follicular phase

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

Arms:

Tamoxifen stim in luteal phase

Size

102

Primary endpoint

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.

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

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 102, 'type': 'ACTUAL'}}

Updated at

2023-08-01

1 organization

1 product

1 indication

Organization

Institut Cancerologie de l'Ouest

Product

Tamoxifen

Indication

Breast Cancer