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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 (MotHER)

This study is currently recruiting participants.
Verified December 2012 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00833963
First received: January 30, 2009
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

The MotHER Pregnancy Registry is a U.S.-based, prospective, observational cohort study established to describe adverse pregnancy complications, pregnancy outcomes, fetal/infant outcomes, and fetal/infant functional deficits among women with breast cancer who were treated with a Herceptin-containing regimen with or without Perjeta during pregnancy or within 6 months prior to conception.


Condition Phase
Breast Cancer
Pregnancy
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Trastuzumab
U.S. FDA Resources

Further study details as provided by Genentech:

Estimated Enrollment: 100
Study Start Date: December 2008
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This study is recruiting patients from anywhere within the United States. No office visits are required to participate in this registry. Information is collected from patients and healthcare providers via telephone.

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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833963

Contacts
Contact: MotHER Registry Coordinating Center 800-690-6720

Locations
United States, North Carolina
MotHER Registry Coordinating Center Recruiting
Wilmington, North Carolina, United States
Sponsors and Collaborators
Genentech
Investigators
Study Director: Vikki Brown, M.D. INC Research, LLC
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00833963     History of Changes
Other Study ID Numbers: H4621g
Study First Received: January 30, 2009
Last Updated: December 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Herceptin
MBC
BC
Pregnancy
childbirth

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013