Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients With Breast Cancer (KSF2)

March 16, 2026 updated by: Centre Oscar Lambret

Long-term Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients Treated for a Breast Cancer

Interventional research with low risks and constraints, prospective and monocentric on the assessment of long-term fertility in patients who underwent an adjuvant sequential chemotherapy with or without a controled ovarian hyperstimulation. This study follows a previous one called NCT 01614704.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The patients will have a follow-up once a year during ten years beginning at the end of their chemotherapy.

They will have a consultation in oncology consisting of:

  • a clinical exam,
  • a collection and follow-up of oncological data
  • a collection of ongoing cancer treatments

and a consultation in gynecology consisting of:

  • a pelvic ultrasound scan (for AFC: Antral Follicle Count)
  • a biological test (FSH, LH, E2, AMH)
  • a collection of gynecological data, contraception and reproductive medicine

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • Not Applicable

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
      • Lille, France
        • Centre Oscar Lambret

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients included in the study CT 01614704
  • Informed and written consent
  • Affiliated to the National Social Security System

Exclusion Criteria:

  • Impossibility to submit at the study procedures due to geographic, social or mental reasons
  • Patient deprived of their liberty or under guardianship or tutorship.

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Process
Consultation, Biological Test, Pelvic Ultrasound
Procedure: Consultation
Consultation in oncology: collection of oncological data and ongoing cancer treatments, clinical exam Consultation in gynecology: collection of gynecological data, contraception and reproductive medicine
Biological: Biological Test

Blood test:

  • FSH, LH, E2 and AMH
  • 4 tubes of 7 mL
Procedure: Pelvic Ultrasound
Antral Follicles Count

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of fertility in terms of cumulative incidence of long-term pregnancy
Time Frame: 10 years after chemotherapy
for patients who underwent adjuvant sequential chemotherapy of anthracycline and taxane separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation
10 years after chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of fertility in terms of cumulative incidence of births
Time Frame: 10 years after chemotherapy
separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation
10 years after chemotherapy
Assessment of fertility - number of pegnancies spontaneous versus assisted
Time Frame: 10 years after chemotherapy
describing the pregnancy type - number of pegnancies spontaneous versus assisted, with ot without the use of frozen gametes)
10 years after chemotherapy
Assessment of fertility - pregnancy outcome : miscarriage or single or multiple birth separately
Time Frame: 10 years after chemotherapy
describing the pregnancy outcome : miscarriage or single or multiple birth separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation
10 years after chemotherapy
Assessment of the number of patient willing to re-exploit their frozen gametes
Time Frame: 10 years after chemotherapy
for patients who have had Controlled Ovarian Hyperstimulation
10 years after chemotherapy
Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - AMH rate
Time Frame: 10 years after chemotherapy
in terms of AMH rate depending on whether or not they have had Controlled Ovarian Hyperstimulation
10 years after chemotherapy
Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - Antral Follicle Count
Time Frame: 10 years after chemotherapy
in terms of Antral Follicle Count depending on whether or not they have had Controlled Ovarian Hyperstimulation
10 years after chemotherapy
Study the long-term carcinologic safety of Controlled Ovarian Hyperstimulation without Letrozole or Tamoxifen co-treatment in terms of survival without relapse
Time Frame: After chemotherapy ad until disease progression or death regardless of the cause, up to 10 years after chemotherapy
Survival without relapse defined by the time frame between the date of surgery and the date of the first recurrence
After chemotherapy ad until disease progression or death regardless of the cause, up to 10 years after chemotherapy

Collaborators and Investigators

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

Sponsor

Centre Oscar Lambret

Investigators

  • Study Director: Audrey MAILLIEZ, MD, Centre Oscar Lambret
  • Study Director: Christine DECANTER, MD, Centre Hopsitalier Regional Universitaire de Lille - Hôpital Jeanne de Flandre

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)

April 12, 2018

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

December 31, 2018

First Submitted That Met QC Criteria

January 4, 2019

First Posted (Actual)

January 7, 2019

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSF2-1707
  • 2017-A03112-51 (Other Identifier: ANSM)

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.

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