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.
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

January 30, 2009
September 3, 2013
December 2008
December 2022   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00833963 on ClinicalTrials.gov Archive Site
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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)
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

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).

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Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
19 Months
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Non-Probability Sample

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.

  • Breast Cancer
  • Pregnancy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2022
December 2022   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: MotHER Registry Coordinating Center 800-690-6720
United States
 
NCT00833963
H4621g
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Genentech
Genentech
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Study Director: Vikki Brown, M.D. INC Research, LLC
Genentech
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP