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

This study is currently recruiting participants.
Verified November 2017 by Genentech, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00833963
First Posted: February 2, 2009
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
January 30, 2009
February 2, 2009
November 14, 2017
January 14, 2009
January 31, 2025   (Final data collection date for primary outcome measure)
  • Number of Participants Developing Oligohydramnios [ Time Frame: From enrollment up to the delivery or upon termination of pregnancy (up to 12 months) ]
  • Number of Live Births [ Time Frame: From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months) ]
  • Number of Fetal Deaths/Stillbirths [ Time Frame: From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months) ]
  • Number of Fetal or Infant Major Malformations [ Time Frame: From delivery up to 12 months after delivery ]
  • Number of Fetal or Infant Deformations [ Time Frame: From delivery up to 12 months after delivery ]
  • Number of Fetal or Infant Disruptions [ Time Frame: From delivery up to 12 months after delivery ]
  • Number of Fetal or Infant Functional Deficits [ Time Frame: From delivery up to 12 months after delivery ]
Not Provided
Complete list of historical versions of study NCT00833963 on ClinicalTrials.gov Archive Site
  • Number of Spontaneous Abortions [ Time Frame: From enrollment up to 12 months ]
  • Number of Therapeutic Abortions, or Elective Abortions [ Time Frame: From enrollment up to 12 months ]
  • Number of Premature Births [ Time Frame: From enrollment up to 12 months ]
  • Number of Infants Small for Gestational Age [ Time Frame: From delivery up to 12 months after delivery ]
  • Number of Cases of Intrauterine Growth Restriction (IUGR) [ Time Frame: From enrollment up to 12 months ]
  • Number of Other Specific Pregnancy or Delivery Complications [ Time Frame: From enrollment up to 12 months ]
Not Provided
Not Provided
Not Provided
 
A Study of Pregnancy and Pregnancy Outcomes in Women With Breast Cancer Treated With Trastuzumab, Pertuzumab in Combination With Trastuzumab, or Ado-Trastuzumab Emtansine
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
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).
Not Provided
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
12 Months
Not Provided
Non-Probability Sample
This study is recruiting participants from anywhere within the United States. No office visits are required to participate in this registry. Information is collected from participants based on their medical charts.
  • Breast Cancer
  • Pregnancy
  • Drug: Trastuzumab
    Participants will receive trastuzumab as determined by their treating physicians' standards of care.
    Other Name: Herceptin
  • Drug: Pertuzumab
    Participants will receive pertuzumab as determined by their treating physicians' standards of care.
    Other Name: Perjeta
  • Drug: Ado-Trastuzumab Emtansine
    Participants will receive ado-trastuzumab emtansine as determined by their treating physicians' standards of care.
    Other Name: Kadcyla
  • Participants Treated With Trastuzumab
    Participants who are being treated with trastuzumab during pregnancy or within 7 months prior to conception will be evaluated for cancer and pregnancy as determined by their treating physicians' standards of care, and will be observed for up to 12 months after delivery.
    Intervention: Drug: Trastuzumab
  • Participants Treated With Trastuzumab and Pertuzumab
    Participants who are being treated with the combination of trastuzumab and pertuzumab during pregnancy or within 7 months prior to conception will be evaluated for cancer and pregnancy as determined by their treating physicians' standards of care, and will be observed for up to 12 months after delivery.
    Interventions:
    • Drug: Trastuzumab
    • Drug: Pertuzumab
  • Participants Treated With Ado-Trastuzumab Emtansine
    Participants who are being treated with ado-trastuzumab emtansine during pregnancy or within 7 months prior to conception will be evaluated for cancer and pregnancy as determined by their treating physicians' standards of care, and will be observed for up to 12 months after delivery.
    Intervention: Drug: Ado-Trastuzumab Emtansine
Not Provided
 
Recruiting
100
January 31, 2025
January 31, 2025   (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 (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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact: MotHER Registry Coordinating Center www.motherpregnancyregistry.com 800-690-6720
United States
 
 
NCT00833963
H4621g
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Vikki Brown, M.D. INC Research
Genentech, Inc.
November 2017