An Observational Study of Pregnancy and Pregnancy Outcomes in Women With Breast Cancer Treated With Herceptin, Perjeta in Combination With Herceptin, or Kadcyla During Pregnancy or Within 7 Months Prior to Conception
Overview
- Phase
- N/A
- Intervention
- Trastuzumab
- Conditions
- Breast Cancer
- Sponsor
- Genentech, Inc.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Number of Participants Developing Oligohydramnios
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
Participants Treated With Trastuzumab
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.
Intervention: Trastuzumab
Participants Treated With Trastuzumab and Pertuzumab
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.
Intervention: Trastuzumab
Participants Treated With Trastuzumab and Pertuzumab
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.
Intervention: Pertuzumab
Participants Treated With Ado-Trastuzumab Emtansine
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.
Intervention: Ado-Trastuzumab Emtansine
Outcomes
Primary Outcomes
Number of Participants Developing Oligohydramnios
Time Frame: From enrollment up 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 Live Births
Time Frame: From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months)
Number of Fetal or Infant Deformations
Time Frame: From delivery up to 12 months after delivery
Number of Fetal or Infant Major Malformations
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 Fetal or Infant Disruptions
Time Frame: From delivery up to 12 months after delivery
Secondary Outcomes
- Number of Spontaneous 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 Therapeutic Abortions, or Elective Abortions(From enrollment up to 12 months)
- Number of Other Specific Pregnancy or Delivery Complications(From enrollment up to 12 months)
- Number of Cases of Intrauterine Growth Restriction (IUGR)(From enrollment up to 12 months)