Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility

NCT ID: NCT01614704

Last Updated: 2019-06-20

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 135 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2019-03-31

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.

Conditions

Breast Cancer; Fertility

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Neo adjuvant treatment

patients in this group will only have the follow up of the follicule stock.

No interventions assigned to this group

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Oscar Lambret

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Audrey MAILLIEZ, MD

Role: STUDY_CHAIR

Oscar Lambret Center

Christine DECANTER, MD

Role: STUDY_CHAIR

CHRU LILLE

Locations

Oscar Lambret Center

Lille, Hauts-de-France, France

Countries

France

Other Identifiers

Cancer et fertilité - 1104

Identifier Type: -

Identifier Source: org_study_id