Skip to main content
OpenTrials
Completed

NCT Number: NCT00833963

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Pregnancy Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Kendle International, Inc

Wilmington, North Carolina, 28405, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trastuzumab

Drug

Participants will receive trastuzumab as determined by their treating physicians' standards of care.

Other names: Herceptin

Pertuzumab

Drug

Participants will receive pertuzumab as determined by their treating physicians' standards of care.

Other names: Perjeta

ado-trastuzumab emtansine

Drug

Participants will receive ado-trastuzumab emtansine as determined by their treating physicians' standards of care.

Other names: Kadcyla

Primary outcomes

  1. Number of Participants Developing Oligohydramnios

    Time frame: From enrollment up to the delivery or upon termination of pregnancy (up to 12 months)

  2. Number of Live Births

    Time frame: From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months)

  3. Number of Fetal Deaths/Stillbirths

    Time frame: From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months)

  4. Number of Fetal or Infant Major Malformations

    Time frame: From delivery up to 12 months after delivery

  5. Number of Fetal or Infant Deformations

    Time frame: From delivery up to 12 months after delivery

  6. Number of Fetal or Infant Disruptions

    Time frame: From delivery up to 12 months after delivery

  7. Number of Fetal or Infant Functional Deficits

    Time frame: From delivery up to 12 months after delivery

Secondary outcomes

  1. Number of Spontaneous Abortions

    Time frame: From enrollment up to 12 months

  2. Number of Therapeutic Abortions, or Elective Abortions

    Time frame: From enrollment up to 12 months

  3. Number of Premature Births

    Time frame: From enrollment up to 12 months

  4. Number of Infants Small for Gestational Age

    Time frame: From delivery up to 12 months after delivery

  5. Number of Cases of Intrauterine Growth Restriction (IUGR)

    Time frame: From enrollment up to 12 months

  6. Number of Other Specific Pregnancy or Delivery Complications

    Time frame: From enrollment up to 12 months

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Acronym: MotHER

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Feb 2, 2009
Registry last updated
May 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.