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Clinical Trial NCT02890082 (PRESAGE) for Breast Cancer is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Preservation of Fertility by Ovarian Stimulation Associated With Tamoxifen, Prior Chemotherapy for Breast Cancer (PRESAGE) Phase 2 102

Active, not recruiting
Clinical Trial NCT02890082 (PRESAGE) is designed to study Other for Breast Cancer. It is a Phase 2 interventional study that is active, not recruiting, having started on 1 February 2014, with plans to enroll 102 participants. Led by Institut Cancerologie de l'Ouest, it is expected to complete by 1 January 2028. The latest data from ClinicalTrials.gov was last updated on 2 August 2024.
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 adju...

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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 therap...Show More
Official Title

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

Conditions
Breast Cancer
Other Study IDs
  • PRESAGE
  • ICO-N-2013-03
NCT ID Number
NCT02890082
Start Date (Actual)
2014-02
Last Update Posted
2024-08-02
Completion Date (Estimated)
2028-01
Enrollment (Estimated)
102
Study Type
Interventional
PHASE
Phase 2
Status
Active, not recruiting
Keywords
Breast cancer
fertility
chemotherapy
Primary Purpose
Other
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalTamoxifen stim in early follicular phase
Day cycle of the patient when ovarian stimulation begin (early follicular phase) = D1 to D3
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) in...Show More
OtherTamoxifen stim in late follicular phase
Day cycle of the patient when ovarian stimulation begin (late follicular phase) = D4 to D14
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 30...Show More
OtherTamoxifen stim in luteal phase
Day cycle of the patient when ovarian stimulation begin (luteal phase) = D15 to D28
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 * Trigg...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
number of pregnancy obtain
At least 2 years After chemotherapy
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
Female
  • 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.

  • 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.
Institut Cancerologie de l'Ouest logoInstitut Cancerologie de l'Ouest
No contact data.
1 Study Locations in 1 Countries
ICO René Gauducheau, Nantes, 44805, France