A Study Evaluating the Pregnancy Outcomes and Safety of Interrupting Endocrine Therapy for Young Women With Endocrine Responsive Breast Cancer Who Desire Pregnancy (IBCSG48-POSITIVE)

Investigating Hormone-Blocking Treatment Interruption and Breast Cancer Recurrence

Recruiting
18 years - 42 years
Female
Phase N/A
1 Location

Brief description of study.

The aim of the study is to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of breast cancer recurrence. The study aims also to evaluate different specific indicators related to fertility, pregnancy and breast cancer biology in young women.

Detailed description of study

The aim of the study is to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of breast cancer recurrence. The study aims also to evaluate different specific indicators related to fertility, pregnancy and breast cancer biology in young women.
Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Early Breast Cancer,breast cancer,cancer,oncology,pregnancy
  • Age: 18 years - 42 years
  • Gender: Female

Inclusion Criteria
In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Has received adjuvant endocrine therapy (SERM alone, GnRH analogue plus SERM or AI) for ≥18 months but ≤30 months for early breast cancer. Note: Patients who have received neo/adjuvant endocrine treatment within a clinical trial and patients who have received pharmaco-prevention are eligible.
  • Patient wishes to become pregnant. Note: Patients who have undergone oocyte/embryo/ovarian tissue cryopreservation at breast cancer diagnosis and/or have a previous history of assisted reproductive technology (ART) are eligible.

For a full list of participation criteria, please visit clinicaltrials.gov.

Updated on 19 Feb 2024. Study ID: 1709298553 (A221405)

This study investigates if taking a break from endocrine therapy to allow pregnancy affects the risk of breast cancer coming back. It focuses on young women who have had early breast cancer and are interested in becoming pregnant. Endocrine therapy involves using medicines that block certain hormones to slow or stop the growth of cancer. The study will also look at different factors related to fertility, pregnancy, and breast cancer biology.

Participants in the study will have their endocrine therapy temporarily stopped to permit pregnancy. The study will monitor various health indicators related to fertility and breast cancer. Participants will not receive any payment for their involvement in the study.

  • Who can participate: Women on endocrine therapy for early breast cancer for 18 to 30 months who wish to become pregnant can participate. Those who have used reproductive technologies or preserved reproductive tissues are also eligible.
  • Study details: Participants will stop their endocrine therapy to try and become pregnant. The study will observe fertility and health indicators. There is no payment for participation.

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