Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility

NCT01614704 | Terminated

• 1 other identifier: Cancer et fertilité - 1104
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

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

Keywords

Breast cancer; Fertility

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• amenorrhea chemotherapeutically induced (weeks)

  4 years

• correlation between amenorrhea duration and oncologic outcome (overall and free disease survival)

  4 years

• correlation between ovarian stimulation safety and oncologic outcome (overall and free disease survival)

  4 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

young female, treated for non metastatic breast cancer

You may qualify if:

• ≤ age \< 38
• breast cancer histologically proved
• under the control of an adjuvant chemotherapy or neo adjuvant chemotherapy
• verbal agreement given

You may not qualify if:

• age ≥ 38
• metastatic breast cancer
• non able to follow the design of the study (geographic, social or psychological reasons)

Sponsors & Collaborators

• Centre Oscar Lambret: lead

Study Sites (1)

Oscar Lambret Center

Lille, Hauts-de-France, 59020, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Audrey MAILLIEZ, MD

  Oscar Lambret Center

  STUDY CHAIR

• Christine DECANTER, MD

  CHRU LILLE

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2012
• First Posted: June 8, 2012
• Study Start: October 1, 2011
• Primary Completion: November 1, 2016
• Study Completion: March 1, 2019
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)