Breast CancerKSF2NCT03795246
Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients With Breast Cancer
A study testing Consultation, Biological Test and Pelvic Ultrasound in people with Breast Cancer, run by Centre Oscar Lambret at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Consultation, Biological Test and Pelvic Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2018to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients included in the study CT 01614704
- Informed and written consent
- Affiliated to the National Social Security System
Who cannot join
- Impossibility to submit at the study procedures due to geographic, social or mental reasons
- Patient deprived of their liberty or under guardianship or tutorship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Breast Cancer
- Being tested
- Consultation, Biological Test, Pelvic Ultrasound
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConsultationProcedure or surgery
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 TestBiological
Blood test:
- FSH, LH, E2 and AMH
- 4 tubes of 7 mL
Pelvic UltrasoundProcedure or surgery
Antral Follicles Count
| Study group | Role | What they receive |
|---|---|---|
| Study Process | Experimental | Consultation, Biological Test, Pelvic Ultrasound Receives: Procedure: Consultation; Biological: Biological Test; Procedure: Pelvic Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of fertility in terms of cumulative incidence of long-term pregnancy
for patients who underwent adjuvant sequential chemotherapy of anthracycline and taxane separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation
Measured: 10 years after chemotherapy
Secondary outcomes (7)
Assessment of fertility in terms of cumulative incidence of births
separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation
Measured: 10 years after chemotherapy
Assessment of fertility - number of pegnancies spontaneous versus assisted
describing the pregnancy type - number of pegnancies spontaneous versus assisted, with ot without the use of frozen gametes)
Measured: 10 years after chemotherapy
Assessment of fertility - pregnancy outcome : miscarriage or single or multiple birth separately
describing the pregnancy outcome : miscarriage or single or multiple birth separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation
Measured: 10 years after chemotherapy
Assessment of the number of patient willing to re-exploit their frozen gametes
for patients who have had Controlled Ovarian Hyperstimulation
Measured: 10 years after chemotherapy
Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - AMH rate
in terms of AMH rate depending on whether or not they have had Controlled Ovarian Hyperstimulation
Measured: 10 years after chemotherapy
Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - Antral Follicle Count
in terms of Antral Follicle Count depending on whether or not they have had Controlled Ovarian Hyperstimulation
Measured: 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
Survival without relapse defined by the time frame between the date of surgery and the date of the first recurrence
Measured: After chemotherapy ad until disease progression or death regardless of the cause, up to 10 years after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start12 Apr 2018
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audrey MAILLIEZ, MD, Study director, Centre Oscar LambretChristine DECANTER, MD, Study director, Centre Hopsitalier Regional Universitaire de Lille - Hôpital Jeanne de Flandre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795246
- Sponsor's protocol ID
- KSF2-1707
- Other IDs
- 2017-A03112-51
- Acronym
- KSF2
- Status last verified
- Mar 2026
- First submitted
- 31 Dec 2018
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients Treated for a Breast Cancer
- ClinicalTrials.gov ID
- NCT03795246
- Acronym / sponsor ID
- KSF2 / KSF2-1707
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 7 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Process | Experimental | Procedure: Consultation, Biological: Biological Test, Procedure: Pelvic UltrasoundConsultation, Biological Test, Pelvic Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients included in the study CT 01614704
- Informed and written consent
- Affiliated to the National Social Security System
Key exclusion criteria (2 listed)
- Impossibility to submit at the study procedures due to geographic, social or mental reasons
- Patient deprived of their liberty or under guardianship or tutorship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ConsultationConsultation in oncology: collection of oncological data and ongoing cancer treatments, clinical exam Consultation in gynecology: collection of gynecological data, contraception and reproductive medicine | Procedure or surgery | Study Process |
| Biological TestBlood test: * FSH, LH, E2 and AMH * 4 tubes of 7 mL | Biological | Study Process |
| Pelvic UltrasoundAntral Follicles Count | Procedure or surgery | Study Process |
Primary outcome
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
7 secondary outcomes
Assessment of fertility in terms of cumulative incidence of births
Time frame: 10 years after chemotherapy
Assessment of fertility - number of pegnancies spontaneous versus assisted
Time frame: 10 years after chemotherapy
Assessment of fertility - pregnancy outcome : miscarriage or single or multiple birth separately
Time frame: 10 years after chemotherapy
Assessment of the number of patient willing to re-exploit their frozen gametes
Time frame: 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
Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - Antral Follicle Count
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audrey MAILLIEZ, MD study director
Centre Oscar Lambret
Christine DECANTER, MD study director
Centre Hopsitalier Regional Universitaire de Lille - Hôpital Jeanne de Flandre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consultation, Biological Test and Pelvic Ultrasound in people with Breast Cancer, run by Centre Oscar Lambret at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of fertility in terms of cumulative incidence of long-term pregnancy (time frame: 10 years after chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.