Breast Cancer, Pregnancy
Conditions
Brief summary
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).
Interventions
DRUGTrastuzumab
Participants will receive trastuzumab as determined by their treating physicians' standards of care.
DRUGPertuzumab
Participants will receive pertuzumab as determined by their treating physicians' standards of care.
Participants will receive ado-trastuzumab emtansine as determined by their treating physicians' standards of care.
Sponsors
Genentech, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnant; women identified at any trimester of pregnancy may enroll in this study as long as enrollment occurs prior to experiencing pregnancy outcome (that is \[i.e.\], live birth, stillbirth, or abortion) * Exposure to at least one dose of trastuzumab (as adjuvant or metastatic treatment), pertuzumab plus trastuzumab combination treatment, or ado-trastuzumab emtansine during pregnancy or within 7 months prior to conception * United States resident
Exclusion criteria
* Prior knowledge of pregnancy outcome (i.e., live birth, stillbirth, or abortion) at time of enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Fetal or Infant Functional Deficits | From delivery up to 12 months after delivery |
| Number of Participants Developing Oligohydramnios | From enrollment up to the delivery or upon termination of pregnancy (up to 12 months) |
| Number of Live Births | From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months) |
| Number of Fetal Deaths/Stillbirths | From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months) |
| Number of Fetal or Infant Major Malformations | From delivery up to 12 months after delivery |
| Number of Fetal or Infant Deformations | From delivery up to 12 months after delivery |
| Number of Fetal or Infant Disruptions | From delivery up to 12 months after delivery |
Secondary
| Measure | Time frame |
|---|---|
| Number of Therapeutic Abortions, or Elective Abortions | From enrollment up to 12 months |
| Number of Premature Births | From enrollment up to 12 months |
| Number of Infants Small for Gestational Age | From delivery up to 12 months after delivery |
| Number of Cases of Intrauterine Growth Restriction (IUGR) | From enrollment up to 12 months |
| Number of Other Specific Pregnancy or Delivery Complications | From enrollment up to 12 months |
| Number of Spontaneous Abortions | From enrollment up to 12 months |
Countries
United States
Outcome results
None listed