Breast Cancer, Fertility
Conditions
Keywords
Breast cancer, Fertility
Brief summary
Breast cancer affect around 52 000 women in France each year. Amongst them, 7% are less than 40 years old and 2% are in between 25 and 35 years old. Significant therapeutic advances have improved the prognostic of these patients. They will all most likely to received chemotherapy. Despite the fact that chemotherapy has many side effects, these women do question the impact of the treatment on their ability to procreate. On 06/08/04 law basis, each patient is allowed to preserve gametes or germinal tissues when medical care potentially affect fertility. Functional evaluation of ovarian reserve could help comprehend new chemotherapy protocols, provide fertility information, and help individualize fertility preservation supports. Principal objective is to ensure the absence of ovarian stimulation's side effects and assess chemotherapy effects on child carrying potential.
Interventions
None listed
Sponsors
Centre Oscar Lambret
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
Inclusion criteria
* 18 ≤ age \< 38 * breast cancer histologically proved * under the control of an adjuvant chemotherapy or neo adjuvant chemotherapy * verbal agreement given
Exclusion criteria
* age ≥ 38 * metastatic breast cancer * non able to follow the design of the study (geographic, social or psychological reasons)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline of Anti Mullerian Hormone (AMH) rate to different time points until 24 months | baseline, Day 1 of Cycle 2, Day 1 of Cycle 4, Day 1 of Cycle 6, 3 months, 6 months, 9 months, 12 months, 24 months | variation of percentages of AMH rate compared to baseline - Observe sequential chemotherapy on ovarian follicular content |
| change from baseline of account of antral follicles (CFA) rate to different time points until 24 months | baseline, Day 1 of Cycle 2, Day 1 of Cycle 4, Day 1 of Cycle 6, 3 months, 6 months, 9 months, 12 months, 24 months | variation of percentages of CFA rate compared to baseline - Observe sequential chemotherapy on ovarian follicular content |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| amenorrhea chemotherapeutically induced (weeks) | 4 years | observe chemotherapy induced amenorrhea frequency and duration of amenorrhea |
| correlation between amenorrhea duration and oncologic outcome (overall and free disease survival) | 4 years | collection of amenorrhea duration (weeks) |
| correlation between ovarian stimulation safety and oncologic outcome (overall and free disease survival) | 4 years | toxicity assessment |
Countries
France
Contacts
STUDY_CHAIRAudrey MAILLIEZ, MD
Oscar Lambret Center
STUDY_CHAIRChristine DECANTER, MD
CHRU LILLE
Outcome results
None listed