An observational study in Breast Cancer and Pregnancy, sponsored by Genentech, Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-16.
Sponsored by Genentech, Inc. · Observational
The MotHER Pregnancy Registry is a United States (U.S.)-based, prospective, observational cohort study in women with breast cancer who have been or are being treated with a trastuzumab (herceptin)-containing regimen with or without pertuzumab (perjeta) or ado-trastuzumab emtansine (kadcyla) during pregnancy or within 7 months prior to conception (regardless of cancer stage at the time of trastuzumab, pertuzumab, or ado-trastuzumab emtansine exposure).
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 20 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
This study is recruiting participants from anywhere within the United States. No office visits are required to participate in this registry. Information is collected from participants based on their medical charts.
Exclusion Criteria:
Participants who are being treated with trastuzumab during pregnancy or within 7 months prior to conception will be evaluated for cancer and pregnancy as determined by their treating physicians' standards of care, and will be observed for up to 12 months after delivery.
Drug: Trastuzumab
Participants who are being treated with the combination of trastuzumab and pertuzumab during pregnancy or within 7 months prior to conception will be evaluated for cancer and pregnancy as determined by their treating physicians' standards of care, and will be observed for up to 12 months after delivery.
Drug: Trastuzumab · Drug: Pertuzumab
Participants who are being treated with ado-trastuzumab emtansine during pregnancy or within 7 months prior to conception will be evaluated for cancer and pregnancy as determined by their treating physicians' standards of care, and will be observed for up to 12 months after delivery.
Drug: Ado-Trastuzumab Emtansine
Participants will receive trastuzumab as determined by their treating physicians' standards of care.
Also known as: Herceptin
Participants will receive pertuzumab as determined by their treating physicians' standards of care.
Also known as: Perjeta
Participants will receive ado-trastuzumab emtansine as determined by their treating physicians' standards of care.
Also known as: Kadcyla
Number of Participants Developing Oligohydramnios
Time frame: From enrollment up to the delivery or upon termination of pregnancy (up to 12 months)
Number of Live Births
Time frame: From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months)
Number of Fetal Deaths/Stillbirths
Time frame: From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months)
Number of Fetal or Infant Major Malformations
Time frame: From delivery up to 12 months after delivery
Number of Fetal or Infant Deformations
Time frame: From delivery up to 12 months after delivery
Number of Fetal or Infant Disruptions
Time frame: From delivery up to 12 months after delivery
Number of Fetal or Infant Functional Deficits
Time frame: From delivery up to 12 months after delivery
Number of Spontaneous Abortions
Time frame: From enrollment up to 12 months
Number of Therapeutic Abortions, or Elective Abortions
Time frame: From enrollment up to 12 months
Number of Premature Births
Time frame: From enrollment up to 12 months
Number of Infants Small for Gestational Age
Time frame: From delivery up to 12 months after delivery
Number of Cases of Intrauterine Growth Restriction (IUGR)
Time frame: From enrollment up to 12 months
Number of Other Specific Pregnancy or Delivery Complications
Time frame: From enrollment up to 12 months
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Genentech, Inc.