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Trial record 3 of 13 for:    presage

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

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2016 by Institut Cancerologie de l'Ouest
Sponsor:
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier:
NCT02890082
First received: August 26, 2016
Last updated: September 6, 2016
Last verified: August 2016
  Purpose

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.


Condition Intervention Phase
Breast Cancer Drug: Tamoxifen stim in early follicular phase Drug: Tamoxifen stim in late follicular phase Drug: Tamoxifen stim in luteal phase Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Pilot Study of Preservation of Fertility by Ovarian Stimulation Associated With Tamoxifen, and Freezing Oocyte or Embryo Prior Chemotherapy for Breast Cancer

Resource links provided by NLM:


Further study details as provided by Institut Cancerologie de l'Ouest:

Primary Outcome Measures:
  • 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. [ Time Frame: max 1 month after beginning of stimulation (At the end of oocyte puncture after ovarian stimulation) ]

    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.



Secondary Outcome Measures:
  • number of pregnancy obtain [ Time Frame: At least 2 years After chemotherapy ]

Estimated Enrollment: 100
Study Start Date: February 2014
Estimated Study Completion Date: February 2023
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tamoxifen stim in early follicular phase
Day cycle of the patient when ovarian stimulation begin (early follicular phase) = D1 to D3
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
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.
Tamoxifen stim in luteal phase
Day cycle of the patient when ovarian stimulation begin (luteal phase) = D15 to D28
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02890082

Contacts
Contact: PACTEAU Valérie +33 2 40 67 99 00 valerie.pacteau@ico.unicancer.fr
Contact: BORDES Virginie, MD +33 2 40 67 99 00 virginie.bordes@ico.unicancer.fr

Locations
France
ICO René Gauducheau Recruiting
Nantes - St herblain, France, 44805
Contact: BORDES Virginie, MD    +33 2 40 67 99 00    virginie.bordes@ico.unicancer.fr   
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Investigators
Principal Investigator: BORDES Virginie, MD Institut de Cancérologie de l'Ouest
  More Information

Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT02890082     History of Changes
Other Study ID Numbers: ICO-N-2013-03
Study First Received: August 26, 2016
Last Updated: September 6, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Institut Cancerologie de l'Ouest:
Breast cancer
fertility
chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 21, 2017