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Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility

This study has been terminated.
(End of study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01614704
First Posted: June 8, 2012
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Oscar Lambret
May 18, 2012
June 8, 2012
February 23, 2017
October 2011
September 2018   (Final data collection date for primary outcome measure)
  • 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
change from baseline of Anti Mullerian Hormone (AMH) rate and account of antral follicles (CFA) rate to differents 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 and CFA rate compared to baseline - Observe sequential chemotherapy on ovarian follicular content
Complete list of historical versions of study NCT01614704 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility
Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
young female, treated for non metastatic breast cancer
  • Breast Cancer
  • Fertility
Not Provided
  • Adjuvant treatment
    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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
135
September 2018
September 2018   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
18 Years to 38 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01614704
Cancer et fertilité - 1104
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Centre Oscar Lambret
Centre Oscar Lambret
Not Provided
Study Chair: Audrey MAILLIEZ, MD Oscar Lambret Center
Study Chair: Christine DECANTER, MD CHRU Lille
Centre Oscar Lambret
February 2017