An Observational Study of Pregnancy and Pregnancy Outcomes in Women With Breast Cancer Treated With Herceptin During Pregnancy or Within 6 Months Prior to Conception - Full Text View

An Observational Study of Pregnancy and Pregnancy Outcomes in Women With Breast Cancer Treated With Herceptin During Pregnancy or Within 6 Months Prior to Conception (motHER)

This study is currently recruiting participants.

Verified by Genentech, January 2009

First Received: January 30, 2009 No Changes Posted

Sponsored by:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00833963

Purpose

The Herceptin Pregnancy Registry is a U.S.-based, prospective, observational cohort study established to obtain data on pregnancy outcomes in women with breast cancer who were treated with a Herceptin-containing regimen during pregnancy or within 6 months prior to conception.

Condition	Phase
Breast Cancer Pregnancy	Phase IV

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	An Observational Study of Pregnancy and Pregnancy Outcomes in Women With Breast Cancer Treated With Herceptin During Pregnancy or Within 6 Months Prior to Conception

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Trastuzumab

U.S. FDA Resources

Further study details as provided by Genentech:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	December 2008

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pregnant; women identified at any trimester of pregnancy may enroll in this study
Exposure to at least one dose of Herceptin (as adjuvant or metastatic treatment) during pregnancy or within 6 months prior to conception
United States resident
Patient has provided 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, Ohio
motHER Registry Coordinating Center	Recruiting
Cincinnati, Ohio, United States, 45202

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Laura McKain, M.D.

Kendle International, Inc.

More Information

No publications provided

Responsible Party:	Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers:	H4621g
Study First Received:	January 30, 2009
Last Updated:	January 30, 2009
ClinicalTrials.gov Identifier:	NCT00833963 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

Herceptin
MBC
BC
Pregnancy
childbirth

Study placed in the following topic categories:

Skin Diseases
Trastuzumab
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Therapeutic Uses

Trastuzumab
Breast Neoplasms
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on August 28, 2009