Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility

Breast Cancer Clinical Trial

Official title:

Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01614704
• Other study ID #: Cancer et fertilité - 1104
• Status: Terminated
• Start date: October 2011
• Est. completion date: March 2019

Study information

• Verified date: June 2019
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 135
• Est. completion date: March 2019
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fertility

Locations

Country	Name	City	State
France	Oscar Lambret Center	Lille	Nord Pas De Calais

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline of Anti Mullerian Hormone (AMH) rate to different time points until 24 months	variation of percentages of AMH rate compared to baseline - Observe sequential chemotherapy on ovarian follicular content	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
Primary	change from baseline of account of antral follicles (CFA) rate to different time points until 24 months	variation of percentages of CFA rate compared to baseline - Observe sequential chemotherapy on ovarian follicular content	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
Secondary	amenorrhea chemotherapeutically induced (weeks)	observe chemotherapy induced amenorrhea frequency and duration of amenorrhea	4 years
Secondary	correlation between amenorrhea duration and oncologic outcome (overall and free disease survival)	collection of amenorrhea duration (weeks)	4 years
Secondary	correlation between ovarian stimulation safety and oncologic outcome (overall and free disease survival)	toxicity assessment	4 years