Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Tolerance of an Ovarian Stimulation Protocol Combining Follicle Stimulating Hormone (FSH) and Degarelix Acetate in Female Candidates for Fertility Preservation Before Chemotherapy for Breast Cancer (DEGASTIM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03947151
Recruitment Status : Not yet recruiting
First Posted : May 13, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

The present investigation aims to evaluate the efficacy of an innovative protocol of controlled ovarian stimulation for breast cancer patients, who are candidates for fertility preservation.

Currently, vitrification of oocytes and/or embryos after controlled ovarian stimulation is the most established method for female fertility preservation. However, this stimulation induces an increase in serum estrogen levels, which is theoretically problematic in case of hormone-sensitive tumors such as breast cancer. The majority of oncology teams accept, in very specific situations (particularly when the tumor has been surgically removed), this ovarian stimulation, because the expected benefits of fertility preservation far outweigh the risks. However, everyone agrees that it would be more comfortable to be able to offer vitrification of oocytes and/or embryos using ovarian stimulation without increasing estrogen levels.

In this research, investigators will evaluate the efficacy of degarelix (Firmagon®), currently indicated for the treatment of prostate cancer, as an innovative ovarian stimulation procedure. Administered at the beginning of ovarian stimulation, they believe it should maintain serum estradiol levels at physiological values at the end of stimulation.


Condition or disease Intervention/treatment Phase
Invasive Ductal Breast Carcinoma Drug: Degarelix injection(s) Phase 2

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Efficacy and Tolerance of an Ovarian Stimulation Protocol Combining FSH and Degarelix Acetate in Female Candidates for Fertility Preservation Before Chemotherapy for Breast Cancer
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
one arm
one arm
Drug: Degarelix injection(s)
1 or 2 degarelix injection(s)
Other Name: Firmagon®




Primary Outcome Measures :
  1. Number of follicles 16 to 20 mm in diameter obtained with estradiolemia <500 pg /mL [ Time Frame: Day of ovulation trigger ]
    Success of the procedure if at least 4 follicles 16 to 20 mm in diameter are obtained on the day of ovulation trigger (36 hours before oocyte collection) with estradiolemia <500 pg / mL


Secondary Outcome Measures :
  1. Serum estradiol levels [ Time Frame: Day of ovulation trigger ]
  2. Percentage of women with hyperestradiolemia [ Time Frame: from the beginning of the controlled ovarian stimulation until Month 2 ]
    Percentage of women with hyperestradiolemia during controlled ovarian stimulation (COS)

  3. Duration of the increase in serum estradiol levels [ Time Frame: from the beginning of the controlled ovarian stimulation until Month 2 ]
  4. Number of oocytes collected [ Time Frame: through oocyte collection, an average of Day 20 ]
    Outcome of ovarian stimulation evaluated by the number of oocytes collected, and the number of mature oocytes vitrified

  5. Number of mature oocytes vitrified [ Time Frame: through oocyte collection, an average of Day 20 ]
    Outcome of ovarian stimulation evaluated by the number of oocytes collected, and the number of mature oocytes vitrified

  6. Nature of serious side effects [ Time Frame: 2 months ]
    Description : Serious side effects associated with treatment with degarelix (MedDRA coding)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with invasive ductal carcinoma breast cancer, whatever the hormonal receptor expression profile
  • Age : 18 - 40 years
  • Presence of 2 ovaries
  • Antral follicular count between 12 and 24 on both ovaries
  • Measurement of serum anti-Müllerian hormone between 2 and 4 ng / mL
  • Tumorectomy or mastectomy performed
  • Indication of adjuvant chemotherapy
  • Indication of preservation of fertility according to an oocyte vitrification technique after controlled ovarian stimulation (COS)
  • Patient in the early follicular phase of the cycle at the start of the controlled ovarian stimulation (COS) (absence of follicle> 10 mm in ultrasound and estradiolemia <50 pg / mL)
  • Oncology team agreement for the controlled ovarian stimulation (COS)
  • Social insured patient
  • Patient who gave her consent to participate by signing the consent of the study

Exclusion Criteria:

  • Indication of neoadjuvant chemotherapy (before surgical excision of the tumor)
  • Patient in late follicular phase or luteal phase
  • Known hypersensitivity to one of the constituents of Firmagon®

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): NCT03947151


Contacts
Layout table for location contacts
Contact: Michaël GRYNBERG, MD, PhD 00 33 1 45 37 40 53 michael.grynberg@aphp.fr
Contact: Marie GODARD 00 33 1 58 41 12 11 marie.godard@aphp.fr

Locations
Layout table for location information
France
Hôpital Antoine Béclère Not yet recruiting
Clamart, France, 92140
Contact: Michaël GRYNBERG    0033145374053    michael.grynberg@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Michaël GRYNBERG, MD, PhD Assistance Publique - Hôpitaux de Paris

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03947151     History of Changes
Other Study ID Numbers: P170407J
2018-000049-38 ( EudraCT Number )
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Fertility preservation
Controlled ovarian stimulation
Oocyte vitrification
GnRH antagonist protocol
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Carcinoma, Ductal, Breast
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma, Ductal
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary