Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility

March 12, 2026 updated by: Centre Oscar Lambret

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59020
        • Oscar Lambret Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

young female, treated for non metastatic breast cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Investigators

  • Study Chair: Audrey MAILLIEZ, MD, Oscar Lambret Center
  • Study Chair: Christine DECANTER, MD, CHRU Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2011

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

May 18, 2012

First Submitted That Met QC Criteria

June 6, 2012

First Posted (Estimated)

June 8, 2012

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cancer et fertilité - 1104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe