Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility
Recruitment status was: Recruiting
Per year, 52 000 women have breast cancer.7% are less than 40, and 2% are between 25 and 35. Most of them will be treated with chemotherapy.
One of the side effects is impact on the fertility. 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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility|
- change from baseline of Anti Mullerian Hormone (AMH) rate to different time points until 24 months [ Time Frame: 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 [ Time Frame: 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
- amenorrhea chemotherapeutically induced (weeks) [ Time Frame: 4 years ]observe chemotherapy induced amenorrhea frequency and duration of amenorrhea
- correlation between amenorrhea duration and oncologic outcome (overall and free disease survival) [ Time Frame: 4 years ]collection of amenorrhea duration (weeks)
- correlation between ovarian stimulation safety and oncologic outcome (overall and free disease survival) [ Time Frame: 4 years ]toxicity assessment
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
|Neo adjuvant treatment|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01614704
|Oscar Lambret Center|
|Lille, Nord Pas de Calais, France, 59020|
|Marie Curie Center|
|Arras, Pas de Calais, France, 62000|
|Study Chair:||Audrey MAILLIEZ, MD||Oscar Lambret Center|