Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility

Terminated

• Conditions: Breast Cancer; Fertility

• Registration Number: NCT01614704
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-05-18
• Study First Submitted QC: 2012-06-06
• Study First Posted: 2012-06-08
• Primary Completion: 2016-11
• Study Completion: 2019-03
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-19
• Last Update Posted: 2019-06-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 135

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change from baseline of Anti Mullerian Hormone (AMH) rate to different time points until 24 months	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	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

Name	Time	Method
correlation between amenorrhea duration and oncologic outcome (overall and free disease survival)	4 years	collection of amenorrhea duration (weeks)
amenorrhea chemotherapeutically induced (weeks)	4 years	observe chemotherapy induced amenorrhea frequency and duration of amenorrhea
correlation between ovarian stimulation safety and oncologic outcome (overall and free disease survival)	4 years	toxicity assessment

Trial Locations

Locations (1)

Oscar Lambret Center; 🇫🇷 Lille, Nord Pas De Calais, France