MotHER: A registry for women with breast cancer who received trastuzumab (T) with or without pertuzumab (P) during pregnancy or within 6 months prior to conception.

Abstract

TPS658 Background: T and P are monoclonal antibodies that target different HER2 epitopes. T is approved for treatment of early and metastatic HER2+ BC while P is approved in combination with T for previously untreated HER2+ MBC. Oligohydramnios has been reported in patients (pts) who received T during pregnancy, and also in P-treated pregnant monkeys. Although both antibodies are FDA Pregnancy Category D, indicating evidence of fetal harm, some physicians and pts accept this risk and continue treatment. The MotHER registry was established in 2008 as an FDA postmarketing commitment to evaluate the effects of T therapy on pregnancy outcome; P was included in the study following its approval in 2012. MotHER is the first prospective study of the effects of a targeted cancer therapy on pregnancy outcome. Methods: MotHER is a US registry study of women exposed to T±P during pregnancy or within 6 months prior to conception. Women enroll voluntarily and are followed until pregnancy outcome; infants are followed through the first year of life. Medical information is primarily collected from healthcare providers. Information on potential birth defects noted at birth or during the pediatric follow-up is classified by a birth defect evaluator/clinical geneticist. Enrollment must be initiated before pregnancy outcome. Pts with known prenatal testing results may enroll, but to reduce the potential for bias these pts will be analyzed as a subset. Primary outcomes: number and nature of pregnancy complications, including oligohydramnios, pregnancy outcomes, fetal/infant outcomes and fetal/infant functional deficits. Secondary outcomes: preterm births, elective/therapeutic abortions, miscarriages, fetal growth abnormalities and delivery complications. The study is descriptive and not for formal hypothesis testing; event proportions with CIs will be calculated. The registry will accrue in the US from 2009 to 2019 for T-treated pts and from 2012 to 2022 for P+T-treated pts. The number of potential pts is small therefore physicians are encouraged to refer any eligible pt to increase knowledge about the safety of T±P in pregnancy. herceptinpregnancyregistry.com. Clinical trial information: NCT00833963.

An overview of real‐world data sources for oncology and considerations for research

“…These include the following: 1) administrative claims, 2) electronic health records (EHRs), 3) registries, 4) health care data aggregators, and 5) specialty data providers and networks (Table 1). [11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26] Of note, these categories are somewhat subjective and data sources are dynamic, continually expanding their capture of information through data linkage and collation of other resources. As such, we acknowledge that others may consider specific datasets in different categories.…”