Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients With Breast Cancer (KSF2)
Primary Purpose
Breast Cancer
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Consultation
Biological Test
Pelvic Ultrasound
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer
Eligibility Criteria
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.
Sites / Locations
- Centre Oscar Lambret
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Process
Arm Description
Consultation, Biological Test, Pelvic Ultrasound
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Assessment of fertility in terms of cumulative incidence of births
separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation
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)
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
Assessment of the number of patient willing to re-exploit their frozen gametes
for patients who have had Controlled Ovarian Hyperstimulation
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
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
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
Full Information
NCT ID
NCT03795246
First Posted
December 31, 2018
Last Updated
February 2, 2022
Sponsor
Centre Oscar Lambret
1. Study Identification
Unique Protocol Identification Number
NCT03795246
Brief Title
Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients With Breast Cancer
Acronym
KSF2
Official Title
Long-term Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients Treated for a Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 23, 2018 (Actual)
Primary Completion Date
January 2028 (Anticipated)
Study Completion Date
January 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Process
Arm Type
Experimental
Arm Description
Consultation, Biological Test, Pelvic Ultrasound
Intervention Type
Procedure
Intervention Name(s)
Consultation
Intervention Description
Consultation in oncology: collection of oncological data and ongoing cancer treatments, clinical exam Consultation in gynecology: collection of gynecological data, contraception and reproductive medicine
Intervention Type
Biological
Intervention Name(s)
Biological Test
Intervention Description
Blood test:
FSH, LH, E2 and AMH
4 tubes of 7 mL
Intervention Type
Procedure
Intervention Name(s)
Pelvic Ultrasound
Intervention Description
Antral Follicles Count
Primary Outcome Measure Information:
Title
Assessment of fertility in terms of cumulative incidence of long-term pregnancy
Description
for patients who underwent adjuvant sequential chemotherapy of anthracycline and taxane separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation
Time Frame
10 years after chemotherapy
Secondary Outcome Measure Information:
Title
Assessment of fertility in terms of cumulative incidence of births
Description
separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation
Time Frame
10 years after chemotherapy
Title
Assessment of fertility - number of pegnancies spontaneous versus assisted
Description
describing the pregnancy type - number of pegnancies spontaneous versus assisted, with ot without the use of frozen gametes)
Time Frame
10 years after chemotherapy
Title
Assessment of fertility - pregnancy outcome : miscarriage or single or multiple birth separately
Description
describing the pregnancy outcome : miscarriage or single or multiple birth separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation
Time Frame
10 years after chemotherapy
Title
Assessment of the number of patient willing to re-exploit their frozen gametes
Description
for patients who have had Controlled Ovarian Hyperstimulation
Time Frame
10 years after chemotherapy
Title
Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - AMH rate
Description
in terms of AMH rate depending on whether or not they have had Controlled Ovarian Hyperstimulation
Time Frame
10 years after chemotherapy
Title
Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - Antral Follicle Count
Description
in terms of Antral Follicle Count depending on whether or not they have had Controlled Ovarian Hyperstimulation
Time Frame
10 years after chemotherapy
Title
Study the long-term carcinologic safety of Controlled Ovarian Hyperstimulation without Letrozole or Tamoxifen co-treatment in terms of survival without relapse
Description
Survival without relapse defined by the time frame between the date of surgery and the date of the first recurrence
Time Frame
After chemotherapy ad until disease progression or death regardless of the cause, up to 10 years after chemotherapy
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Audrey MAILLIEZ, MD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Christine DECANTER, MD
Organizational Affiliation
Centre Hopsitalier Regional Universitaire de Lille - Hôpital Jeanne de Flandre
Official's Role
Study Director
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
Country
France
12. IPD Sharing Statement
Learn more about this trial
Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients With Breast Cancer
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