A Study of Pregnancy and Pregnancy Outcomes in Women With Breast Cancer Treated With Trastuzumab, Pertuzumab in Combination With Trastuzumab, or Ado-Trastuzumab Emtansine

  • Breast Cancer
Trial Status:

Active, not recruiting

This trial runs in
Cities
  • Wilmington
Trial Identifier:

NCT00833963 H4621g

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      The MotHER Pregnancy Registry is a United States (U.S.)-based, prospective, observational cohort study in women with breast cancer who have been or are being treated with a trastuzumab (herceptin)-containing regimen with or without pertuzumab (perjeta) or ado-trastuzumab emtansine (kadcyla) during pregnancy or within 7 months prior to conception (regardless of cancer stage at the time of trastuzumab, pertuzumab, or ado-trastuzumab emtansine exposure).

      Genentech, Inc. Sponsor
      NCT00833963 , H4621g Trial Identifier
      Trastuzumab, Pertuzumab, Ado-Trastuzumab Emtansine Treatments
      Breast Cancer, Pregnancy Condition
      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 7 Months Prior to Conception

      Eligibility Criteria

      Female Gender
      ≥ 18 Years Age
      No Healthy Volunteers
      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 (that is [i.e.], live birth, stillbirth, or abortion)
      • 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 7 months prior to conception
      • United States resident
      Exclusion Criteria
      • Prior knowledge of pregnancy outcome (i.e., live birth, stillbirth, or abortion) at time of enrollment

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