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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 : July 27, 2020
Sponsor:
Collaborators:
University Hospital, Lille
National Cancer Institute, France
University Hospital, Montpellier
Information provided by (Responsible Party):
Centre Oscar Lambret

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Controlled ovarian hyperstimulation (COH) Procedure: Oocyte/embryo freezing Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation (CHACRY-1501)
Study Start Date : December 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oocyte/embryo cryopreservation
  1. Controlled ovarian hyperstimulation (COH)
  2. Oocyte/embryo freezing
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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Quality of embryos: total number of embryos preserved [ Time Frame: at 44-46 hours post intra-cell sperm injection ]
  2. Type of oocytes [ Time Frame: after oocyte retrieval (35-36 hours after triptorelin injection) ]
    mature, immature, fractured

  3. 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

  4. 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 ]
  5. Antral Follicular Count (AFC) measurement [ Time Frame: baseline, at month 3, at month 12, at month 24 ]
  6. 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)

  7. 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

  8. 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


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871167


Contacts
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Contact: Audrey Maillez, MD a-mailliez@o-lambret.fr
Contact: Christine Decanter, MD +33 3 20 44 68 97 c-decanter@chru-lille.fr

Locations
Show Show 28 study locations
Sponsors and Collaborators
Centre Oscar Lambret
University Hospital, Lille
National Cancer Institute, France
University Hospital, Montpellier
Investigators
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Study Director: Audrey Maillez, MD Centre Oscar Lambret
Study Director: Christine Decanter, MD CHRU of Lille - Hôpital Jeanne de Flandre
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Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT02871167    
Other Study ID Numbers: CHACRY-1501
2016-000808-28 ( EudraCT Number )
PHRC-K14-010 ( Other Grant/Funding Number: INCA )
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Oscar Lambret:
oocyte/embryo cryopreservation
Additional relevant MeSH terms:
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Breast Neoplasms
Infertility
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Diseases, Male
Genital Diseases, Female