Trial Information
An Observational Study Of Pregnancy And Pregnancy Outcomes In Women With Breast Cancer Treated With Herceptin Or Perjeta In Combination With Herceptin During Pregnancy Or Within 6 Months Prior To Conception
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
- Exposure to at least one dose of Herceptin (as adjuvant or metastatic treatment) or
Perjeta plus Herceptin combination treatment during pregnancy or within 6 months
prior to conception
- United States resident
- Patient has provided verbal or written informed consent (on her own behalf and on
behalf of her child)
Exclusion Criteria:
- Prior knowledge of pregnancy outcome at time of enrollment
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Principal Investigator
Vikki Brown, M.D.
Investigator Role:
Study Director
Investigator Affiliation:
INC Research, LLC
Authority:
United States: Food and Drug Administration
Study ID:
H4621g
NCT ID:
NCT00833963
Start Date:
December 2008
Completion Date:
December 2022
Related Keywords:
- Breast Cancer
- Pregnancy
- Herceptin
- MBC
- BC
- Pregnancy
- childbirth
- Breast Neoplasms
Name | Location |
MotHER Registry Coordinating Center |
Wilmington, North Carolina |