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 (MotHER)
Conditions
Breast Cancer - Pregnancy
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Herceptin, MBC, BC, Pregnancy, childbirth, Perjeta, Kadcyla, pertuzumab, ado-trastuzumab emtansine
Study Type
Observational [Patient Registry]
Study Phase
Phase 4
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
Summary
The MotHER Pregnancy Registry is a U.S.-based, prospective, observational cohort study in women with breast cancer who have been or are being treated with herceptin plus perjeta with or without pertuzumab, or ado-trastuzumab emtansine, during pregnancy or within 7 months prior to conception (regardless of cancer stage at the time of trastuzumab, pertuzumab, or ado-trastuzumab emtansine exposure).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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

- 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

- 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
Location
MotHER Registry Coordinating Center
Wilmington, North Carolina, United States
Status: Recruiting
Start Date
December 2008
Completion Date
December 2022
Sponsors
Genentech, Inc.
Source
Genentech, Inc.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page