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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


Phase 4
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Pregnancy

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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 CenterWilmington, North Carolina