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Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Centre Oscar Lambret
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01614704
First received: May 18, 2012
Last updated: August 21, 2014
Last verified: August 2014

May 18, 2012
August 21, 2014
October 2011
October 2015   (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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    collection of amenorrhea duration (weeks)
  • correlation between ovarian stimulation safety and oncologic outcome (overall and free disease survival) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    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

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.

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
  • Neo adjuvant treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
October 2015
October 2015   (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)
Female
18 Years to 37 Years
No
Contact: Yvette VENDEL +33 (0) 3.20.29.59.18 y-vendel@o-lambret.fr
France
 
NCT01614704
Cancer et fertilité - 1104
No
Centre Oscar Lambret
Centre Oscar Lambret
Not Provided
Study Chair: Audrey MAILLIEZ, MD Oscar Lambret Center
Centre Oscar Lambret
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP