Status:
COMPLETED
A Study of Pregnancy and Pregnancy Outcomes in Women With Breast Cancer Treated With Trastuzumab, Pertuzumab in Combination With Trastuzumab, or Ado-Trastuzumab Emtansine
Lead Sponsor:
Genentech, Inc.
Conditions:
Breast Cancer
Pregnancy
Eligibility:
FEMALE
18+ years
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)-con...
Eligibility Criteria
Inclusion
- 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
- Prior knowledge of pregnancy outcome (i.e., live birth, stillbirth, or abortion) at time of enrollment
Key Trial Info
Start Date :
January 14 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 13 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00833963
Start Date
January 14 2009
End Date
April 13 2017
Last Update
May 16 2019
Active Locations (1)
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1
Kendle International, Inc
Wilmington, North Carolina, United States, 28405