Authorised Therapeutic exploratory (Phase II) breast cancer in young women

RISK OF INFERTILITY RELATED TO ADJUVANT CHEMOTHERAPY IN YOUNG BREAST CANCER PATIENTS: OOCYTE/EMBRYO CRYOPRESERVATION

EU CTIS ID: 2024-513078-23-00

What this study is testing

To evaluate efficiency of oocyte or embryo cryopreservation after controlled ovarian stimulation in young breast cancer patients who will receive adjuvant chemotherapy, in particular in terms of numbers of Meta II oocytes that can be vitrified

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Women with newly diagnosed histological proven breast cancer (whatever the grade, size, nodal status, histological type, HR and HER2 status)
  • Aged from 18 to 38 years old
  • Planned adjuvant chemotherapy Standard sequential anthracycline and taxane based chemotherapy (according to local practices) +/- Trastuzumab +/- Hormonotherapy
  • No prior chemotherapy
  • Affiliated to a public health insurance program
  • Signed informed consent form

You likely can't join if

  • 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: primary gonadal failure (primary amenorrhea), ovarian tumor, tumor of the uterus , pituitary or hypothalamus , vaginal bleeding cause undetermined , ovarian cysts or enlarged ovaries, not related to polycystic ovary syndrome, malformation of genitalia incompatible with pregnancy, uterine myomas incompatible with pregnancy
See the full eligibility criteria
Who can join
  • Women with newly diagnosed histological proven breast cancer (whatever the grade, size, nodal status, histological type, HR and HER2 status)
  • Aged from 18 to 38 years old
  • Planned adjuvant chemotherapy Standard sequential anthracycline and taxane based chemotherapy (according to local practices) +/- Trastuzumab +/- Hormonotherapy
  • No prior chemotherapy
  • Affiliated to a public health insurance program
  • Signed informed consent form
  • ADDITIONAL ELIGIBILITY CRITERIA FOR COH : Sufficient ovarian reserve (i-e AMH≥ 6 pmol/l or AFC ≥ 6 follicles)
What rules you out
  • 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: primary gonadal failure (primary amenorrhea), ovarian tumor, tumor of the uterus , pituitary or hypothalamus , vaginal bleeding cause undetermined , ovarian cysts or enlarged ovaries, not related to polycystic ovary syndrome, malformation of genitalia incompatible with pregnancy, uterine myomas incompatible with pregnancy
  • Pregnant or breastfeeding patients
  • Unable for medical follow-up (geographic, social or mental reasons)

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.