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

Institut Cancerologie de l'Ouest

Status and phase: Active, not recruiting; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Tamoxifen stim in early follicular phase; Drug: Tamoxifen stim in luteal phase; Drug: Tamoxifen stim in late follicular phase

Study type: Interventional

Funder types: Other

Identifiers

NCT02890082

ICO-N-2013-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

102 participants in 3 patient groups

Tamoxifen stim in early follicular phase

Experimental group

Description:

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

Treatment:

Drug: Tamoxifen stim in early follicular phase

Tamoxifen stim in late follicular phase

Other group

Description:

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

Treatment:

Drug: Tamoxifen stim in late follicular phase

Tamoxifen stim in luteal phase

Other group

Description:

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

Treatment:

Drug: Tamoxifen stim in luteal phase