Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility
|ClinicalTrials.gov Identifier: NCT01614704|
Recruitment Status : Terminated (End of study)
First Posted : June 8, 2012
Last Update Posted : February 23, 2017
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.
|Condition or disease|
|Breast Cancer Fertility|
|Study Type :||Observational|
|Actual Enrollment :||135 participants|
|Official Title:||Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
Patients in this group will be offered the option of ovarien cryopreservation as well as the follow up of the follicule stock during chemotherapy.
Neo adjuvant treatment
patients in this group will only have the follow up of the follicule stock.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01614704
|Oscar Lambret Center|
|Lille, Nord Pas de Calais, France, 59020|
|Study Chair:||Audrey MAILLIEZ, MD||Oscar Lambret Center|
|Study Chair:||Christine DECANTER, MD||CHRU Lille|