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Title:
A221405 A Study Evaluating the Pregnancy Outcomes and Safety of Interrupting Endocrine Therapy for Young Women with Endocrine Responsive Breast Cancer who Desire Pregnancy
Protocol Number:
NCTNA221405
Phase:
NULL
Physician:
Karen Smith
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
Suburban Hospital
Purpose:
The purpose of this study is to determine whether having a child after temporarily stopping endocrine treatment is feasible and safe in patients with a hormone receptor-positive early breast cancer.
Eligibility:
You may be eligible if you have been diagnosed with and treated for hormone receptor-positive early breast cancer, you are currently taking endocrine therapy, and you have expressed interest in getting pregnant.
Treatment:
If you decide to participate in the study and meet the criteria to take part, you will temporarily stop your current endocrine therapy and attempt to become pregnant. You must have taken at least 18, and not more than 30, months of endocrine treatment before stopping; and you must wait three to five months after stopping endocrine treatment before attempting to become pregnant. Whether you become pregnant or not, you should resume endocrine therapy within 2 years after the endocrine therapy interruption and complete five to ten years of treatment, according to your individual risk and preference, as planned with your treating oncologist.During the time that you have temporarily stopped endocrine therapy, you will be asked to visit your doctor 3, 6, 12, 18 and 24 months after stopping. In addition, you will receive a diary to record information on the pattern of your menses after stopping endocrine therapy. As part of the study we will collect information on your pregnancy outcome (e.g., normal birth, caesarean section, miscarriage, etc.) and offspring outcome (e.g., no complications, preterm birth, low birth weight, birth defects, etc.). The breastfeeding pattern, if applicable (e.g., duration, which breast you use, etc.) will also be recorded.
Population:
Adult
Last Update
03/05/2019 05:03 AM