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

NCT02890082 | Active Not Recruiting Phase 2

• 1 other identifier: ICO-N-2013-03
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer; fertility; chemotherapy

Outcome Measures

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.

  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 Outcomes (1)

• number of pregnancy obtain

  At least 2 years After chemotherapy

Study Arms (3)

Tamoxifen stim in early follicular phase

EXPERIMENTAL

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

Drug: Tamoxifen stim in early follicular phase

Tamoxifen stim in late follicular phase

OTHER

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

Drug: Tamoxifen stim in late follicular phase

Tamoxifen stim in luteal phase

OTHER

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

Drug: Tamoxifen stim in luteal phase

Interventions

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.

Also known as: Hormotherapy

Tamoxifen stim in early follicular phase

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.

Also known as: Hormotherapy

Tamoxifen stim in late follicular phase

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

Also known as: Hormotherapy

Tamoxifen stim in luteal phase

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

ICO René Gauducheau

Nantes, 44805, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Luteal Phase

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Menstrual Cycle; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• BORDES Virginie, MD

  Institut de Cancérologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: September 7, 2016
• Study Start: February 1, 2014
• Primary Completion: July 17, 2017
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)