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Spots Global Cancer Trial Database for Preservation of Fertility by Ovarian Stimulation Associated With Tamoxifen, Prior Chemotherapy for Breast Cancer

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Trial Identification

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

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

Study ID: NCT02890082

Conditions

Breast Cancer

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

ICO René Gauducheau, Nantes, , France

Contact Details

Name: BORDES Virginie, MD

Affiliation: Institut de Cancérologie de l'Ouest

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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