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 6 Months Prior To Conception (MotHER)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00833963
First received: January 30, 2009
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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 a trastuzumab-containing regimen with or without pertuzumab, or ado-trastuzumab emtansine, during pregnancy or within 6 months prior to conception (regardless of cancer stage at the time of trastuzumab, pertuzumab, or ado-trastuzumab emtansine exposure).


Condition Phase
Breast Cancer
Pregnancy
Phase 4

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 19 Months
Official Title: 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 6 Months Prior To Conception

Resource links provided by NLM:


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 trastuzumab (as adjuvant or metastatic treatment), pertuzumab plus trastuzumab combination treatment, or ado-trastuzumab emtansine 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  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: September 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Herceptin
MBC
BC
Pregnancy
childbirth
Perjeta
Kadcyla
pertuzumab
ado-trastuzumab emtansine

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Pertuzumab
Ado-trastuzumab emtansine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014