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Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility

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ClinicalTrials.gov Identifier: NCT01614704
Recruitment Status : Terminated (End of study)
First Posted : June 8, 2012
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret

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.


Condition or disease
Breast Cancer Fertility

Study Type : Observational
Actual Enrollment : 135 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Group/Cohort
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.



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. amenorrhea chemotherapeutically induced (weeks) [ Time Frame: 4 years ]
    observe chemotherapy induced amenorrhea frequency and duration of amenorrhea

  2. correlation between amenorrhea duration and oncologic outcome (overall and free disease survival) [ Time Frame: 4 years ]
    collection of amenorrhea duration (weeks)

  3. correlation between ovarian stimulation safety and oncologic outcome (overall and free disease survival) [ Time Frame: 4 years ]
    toxicity assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
young female, treated for non metastatic breast cancer
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01614704


Locations
France
Oscar Lambret Center
Lille, Nord Pas de Calais, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Study Chair: Audrey MAILLIEZ, MD Oscar Lambret Center
Study Chair: Christine DECANTER, MD CHRU Lille

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01614704     History of Changes
Other Study ID Numbers: Cancer et fertilité - 1104
First Posted: June 8, 2012    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Oscar Lambret:
Breast cancer
Fertility

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases