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Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation (CHACRY-1501)

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ClinicalTrials.gov Identifier: NCT02871167
Recruitment Status : Recruiting
First Posted : August 18, 2016
Last Update Posted : June 13, 2019
Sponsor:
Collaborators:
University Hospital, Lille
National Cancer Institute, France
University Hospital, Montpellier
Information provided by (Responsible Party):
Centre Oscar Lambret

Tracking Information
First Submitted Date  ICMJE July 28, 2016
First Posted Date  ICMJE August 18, 2016
Last Update Posted Date June 13, 2019
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2016)
Quality of oocytes: total number of oocytes preserved [ Time Frame: after oocyte retrieval (35-36 hours after triptorelin injection) ]
The distribution of the total number of oocytes preserved will be summarized by the mean (standard error) and median (range) and presented with a 95% confidence interval.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02871167 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Quality of embryos: total number of embryos preserved [ Time Frame: at 44-46 hours post intra-cell sperm injection ]
  • Type of oocytes [ Time Frame: after oocyte retrieval (35-36 hours after triptorelin injection) ]
    mature, immature, fractured
  • Toxicity related to the controlled ovarian stimulation according to NCI CTCAE v4.0 scale [ Time Frame: 24 months ]
    Toxicities will be tabulated with frequencies and percentages by type of adverse events and by grade
  • Serum AMH measurement [ Time Frame: baseline, at the end of the first sequence of chemotherapy, at the last injection of treatment, at Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24 ]
  • Antral Follicular Count (AFC) measurement [ Time Frame: baseline, at month 3, at month 12, at month 24 ]
  • Number of Spontaneous or medically assisted pregnancy(ies) [ Time Frame: up to 10 years after the end of the study or at 43 years old ]
    To measure the degree of project completion of subsequent pregnancy(ies)
  • Rate of patients wishing for re-utilization of their frozen gametes [ Time Frame: up to 10 years after the end of the study or at 43 years old ]
    To assess the number of patients wishing for re-utilization of their frozen gametes
  • Disease-free survival [ Time Frame: through study completion, an average of 5 years ]
    defined as the interval between inclusion and the first occurrence of local, regional or distant relapse, estimated using the Kaplan-Meier method
Original Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2016)
  • Quality of embryos: total number of embryos preserved [ Time Frame: at 44-46 hours post intra-cell sperm injection ]
  • Type of oocytes [ Time Frame: after oocyte retrieval (35-36 hours after triptorelin injection) ]
    mature, immature, fractured
  • Toxicity related to the controlled ovarian stimulation according to NCI CTCAE v4.0 scale [ Time Frame: 24 months ]
    Toxicities will be tabulated with frequencies and percentages by type of adverse events and by grade
  • Serum AMH measurement [ Time Frame: baseline, at Day 1 of Cycle 4 (each cycle is 28 days), at Day 1 of Cycle 6, at Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24 ]
  • Antral Follicular Count (AFC) measurement [ Time Frame: baseline, at month 3, at month 12, at month 24 ]
  • Number of Spontaneous or medically assisted pregnancy(ies) [ Time Frame: up to 10 years after the end of the study or at 43 years old ]
    To measure the degree of project completion of subsequent pregnancy(ies)
  • Rate of patients wishing for re-utilization of their frozen gametes [ Time Frame: up to 10 years after the end of the study or at 43 years old ]
    To assess the number of patients wishing for re-utilization of their frozen gametes
  • Disease-free survival [ Time Frame: through study completion, an average of 5 years ]
    defined as the interval between inclusion and the first occurrence of local, regional or distant relapse, estimated using the Kaplan-Meier method
  • Questionnaire EORTC QLQ-C30 [ Time Frame: until the 43th birthday of the reproductive ]
    Evaluation of quality of life using scales
  • Questionnaire IN-PATSAT32 (cancer in-patient satisfaction with care) [ Time Frame: until the 43th birthday of the reproductive ]
    Evaluation of quality of life using scales
  • Questionnaire SAQ (Sexual activity questionnaire) [ Time Frame: until the 43th birthday of the reproductive ]
    Evaluation of quality of life using scales
  • Questionnaire HADS (Hospital Anxiety and Depression Scale) [ Time Frame: until the 43th birthday of the reproductive ]
    Evaluation of quality of life using scales
  • Questionnaire MFI20 (Multidimensional Inventor Fatigue) [ Time Frame: until the 43th birthday of the reproductive ]
    Evaluation of quality of life using scales
  • Psychosocial impact [ Time Frame: until the 43th birthday of the reproductive ]
    Psychological consultation (if indicated for the patient)
Current Other Pre-specified Outcome Measures
 (submitted: June 11, 2019)
Translational research : circulating nucleic acids quantification: cell-free DNA and microRNAs on blood sample [ Time Frame: an average of 6 months ]
before 1st cycle of adjuvant chemotherapy, during the adjuvant chemotherapy (end of first sequence), at the end of adjuvant chemotherapy
Original Other Pre-specified Outcome Measures
 (submitted: August 12, 2016)
Translational research : circulating nucleic acids quantification: cell-free DNA and microRNAs on blood sample [ Time Frame: an average of 6 months ]
before 1st cycle of adjuvant chemotherapy, during the adjuvant chemotherapy (day 1 of cycle 4), at the end of adjuvant chemotherapy
 
Descriptive Information
Brief Title  ICMJE Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation
Official Title  ICMJE Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation (CHACRY-1501)
Brief Summary The aim of the study is to perform a French multicenter prospective interventional study in order to assess the feasibility and safety of ovarian hyperstimulation for oocyte / embryo cryopreservation in young women with breast cancer. The oncologic and reproductive benefit / risk ratio will be investigated in the oncology and reproductive area.
Detailed Description

Medical Oncology:

  • Information and collection of consent,
  • Imaging staging,
  • Inclusion
  • Physical examination
  • Contraception advise given

Reproductive medicine center:

  • Ovarian reserve assessment: serum anti-mullerian hormone (AMH) measurement and antral follicle count (AFC) by ultrasound.
  • Serology syphilis, hepatitis B and C, HIV (human immunodeficiency virus). In case of embryo cryopreservation, same serology determination for the men.
  • Infertility risk and fertility preservation techniques information.
  • In case of agreement, this technique will be done during the time-interval between surgery and chemotherapy
  • Fertility preservation (COH stimulation, triggering and oocyte retrieval)

Adjuvant chemotherapy:

  • The chemotherapy regimen is 3 FEC (fluorouracil epirubicin cyclophosphamide) 100 followed by standard chemotherapy (according to local practice) +/- Trastuzumab. Adjuvant chemotherapy may only begin after the oocyte retrieval.
  • Usual adjuvant chemotherapy is not changed

During chemotherapy:

  • Clinical exam before each cycle of chemotherapy
  • AMH, AFC at cycle 6

After chemotherapy:

  • Usual patient monitoring in expert center :

physical examination at Month 3 (M3), M6 M9 M12 M18 and M24 and mammography at M9 then annual

  • AMH at Month 3 (M3), M6 M9 M12 M18 and M24
  • AFC at Month 12 (M12) and M24
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Procedure: Controlled ovarian hyperstimulation (COH)

    After information and consent, patients are addressed to a reproductive medicine center.

    The COH will be performed according to a standardized protocol between surgery and the start of adjuvant chemotherapy. Follicular growth will be achieved with an antagonist protocol and by using high dose recombinant FSH (r-FSH). The triggering of the final follicular and oocyte maturation will be obtained by a GnRH (Gonadotropin Releasing Hormone) agonist injection in order to minimize the risk of ovarian hyper-stimulation.

  • Procedure: Oocyte/embryo freezing
    Egg or embryo freezing will be performed according to a standardized protocol: slow-freezing process for embryo; vitrification technique for oocytes. Cryopreserved oocytes and embryos will be stored in the biological bank of each reproductive medicine center (min. 10 years).
Study Arms  ICMJE Experimental: Oocyte/embryo cryopreservation
  1. Controlled ovarian hyperstimulation (COH)
  2. Oocyte/embryo freezing
Interventions:
  • Procedure: Controlled ovarian hyperstimulation (COH)
  • Procedure: Oocyte/embryo freezing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 12, 2016)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women with histologically proven breast cancer
  • Aged 18 to 38 years old
  • Planned adjuvant chemotherapy
  • No prior chemotherapy
  • Affiliated to a public health insurance program
  • Informed consent signed by the patient

Exclusion Criteria:

  • Metastatic breast cancer
  • Planned neo-adjuvant chemotherapy
  • Hysterectomy
  • Exclusive adjuvant hormonotherapy
  • Positive serology for syphilis, hepatitis B or C, or VIH
  • Contraindication related to use of r-FSH
  • Pregnant or breastfeeding patients
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 38 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Audrey Maillez, MD a-mailliez@o-lambret.fr
Contact: Christine Decanter, MD +33 3 20 44 68 97 c-decanter@chru-lille.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02871167
Other Study ID Numbers  ICMJE CHACRY-1501
2016-000808-28 ( EudraCT Number )
PHRC-K14-010 ( Other Grant/Funding Number: INCA )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Oscar Lambret
Study Sponsor  ICMJE Centre Oscar Lambret
Collaborators  ICMJE
  • University Hospital, Lille
  • National Cancer Institute, France
  • University Hospital, Montpellier
Investigators  ICMJE
Study Director: Audrey Maillez, MD Centre Oscar Lambret
Study Director: Christine Decanter, MD CHRU of Lille - Hôpital Jeanne de Flandre
PRS Account Centre Oscar Lambret
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP