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

Phase 2

Not yet recruiting

• Conditions: Breast cancer

• Registration Number: 2024-516282-37-00
• Lead Sponsor: Institut De Cancerologie De L Ouest, Institut De Cancerologie De L Ouest

Brief Summary

To assess the feasibility of ovarian stimulation combining Tamoxifen with recombinant FSH followed by oocyte vitrification and/or embryo freezing prior to chemotherapy for breast cancer

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.

Study Timeline

• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Obtaining signed informed consent prior to any trial-specific procedure

2. Social protection

3. Between 18 and 40 yo

4. Histologically proven invasive breast carcinoma

5. Indication for adjuvant or neoadjuvant chemotherapy validated by pre-therapy PCR

6. T0-T1-T2-T3

7. N0-N1-N2a

8. M0 after extension assessment according to French INCa recommendations

9. AMH (anti-müllerian hormone) ≥1 ng/mL and/or AFC (antral follicle count) ≥ 5 (on ultrasound: ovaries puncturable transvaginally),

10. HIV serology negative

Exclusion Criteria

1. Previous breast cancer

2. History of any other cancer in the last 5 years, with the exception of basal cell and squamous cell skin cancers

3. Pregnancy in progress

4. Pulmonary embolism less than 6 months old

5. Deep vein thrombosis less than 6 months old

6. Dementia or altered mental state

7. Legal incapacity or limited legal capacity. Medical or psychological conditions preventing the subject from understanding the study and signing the consent form (art. L.1121-6, L.1211-8, L.1211-9).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The feasibility of ovarian stimulation combining Tamoxifen with recombinant FSH as part of fertility preservation prior to chemotherapy for breast cancer will be assessed on the basis of the number of oocytes and/or embryos obtained per patient included.		The feasibility of ovarian stimulation combining Tamoxifen with recombinant FSH as part of fertility preservation prior to chemotherapy for breast cancer will be assessed on the basis of the number of oocytes and/or embryos obtained per patient included.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the average time taken to start chemotherapy: time (in days) between the day of the consultation with the oncologist and the day of administration of the first chemotherapy treatment		Evaluation of the average time taken to start chemotherapy: time (in days) between the day of the consultation with the oncologist and the day of administration of the first chemotherapy treatment
Overall survival / event-free survival at 10 years.		Overall survival / event-free survival at 10 years.
Number of pregnancies obtained: number of positive beta HCG and number of clinical pregnancies.		Number of pregnancies obtained: number of positive beta HCG and number of clinical pregnancies.
Ancillary study (Nantes patients only): Analysis of plasma concentrations of tamoxifen and its metabolites, 4 -hydroxytamoxifen, N - desmethyltamoxifen and endoxifen		Ancillary study (Nantes patients only): Analysis of plasma concentrations of tamoxifen and its metabolites, 4 -hydroxytamoxifen, N - desmethyltamoxifen and endoxifen

Trial Locations

Locations (7)

University Hospital Of Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Institut De Cancerologie De L Ouest; 🇫🇷 Angers, France

Centre De Lutte Contre Le Cancer Eugene Marquis; 🇫🇷 Rennes Cedex, France

Centre Hospitalier Universitaire De Nantes; 🇫🇷 Nantes, France

Centre Hospitalier Universitaire De Rennes; 🇫🇷 Rennes, France

Centre Hospitalier Universitaire D'Angers; 🇫🇷 Angers, France

University Hospital Of Clermont-Ferrand

🇫🇷Clermont-Ferrand, France

Anne-Sophie GREMEAU

Site contact

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anne-sophie.gremeau@chu-clermond-ferrand.fr