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NCT Number: NCT03795246

Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients With 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Oscar Lambret

Lille, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Consultation

Procedure

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 Test

Biological

Blood test:

  • FSH, LH, E2 and AMH
  • 4 tubes of 7 mL

Pelvic Ultrasound

Procedure

Antral Follicles Count

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Official study title

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

Acronym: KSF2

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Jan 7, 2019
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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