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)

May 15, 2019 updated by: Genentech, Inc.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Wilmington, North Carolina, United States, 28405
        • Kendle International, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Trastuzumab
Participants will receive trastuzumab as determined by their treating physicians' standards of care.
Other Names:
  • Herceptin
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.
Drug: Trastuzumab
Participants will receive trastuzumab as determined by their treating physicians' standards of care.
Other Names:
  • Herceptin
Drug: Pertuzumab
Participants will receive pertuzumab as determined by their treating physicians' standards of care.
Other Names:
  • Perjeta
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.
Drug: Ado-Trastuzumab Emtansine
Participants will receive ado-trastuzumab emtansine as determined by their treating physicians' standards of care.
Other Names:
  • Kadcyla

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Developing Oligohydramnios
Time Frame: From enrollment up to the delivery or upon termination of pregnancy (up to 12 months)
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)
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)
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
From delivery up to 12 months after delivery
Number of Fetal or Infant Deformations
Time Frame: From delivery up to 12 months after delivery
From delivery up to 12 months after delivery
Number of Fetal or Infant Disruptions
Time Frame: From delivery up to 12 months after delivery
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
From delivery up to 12 months after delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Spontaneous Abortions
Time Frame: From enrollment up to 12 months
From enrollment up to 12 months
Number of Therapeutic Abortions, or Elective Abortions
Time Frame: From enrollment up to 12 months
From enrollment up to 12 months
Number of Premature Births
Time Frame: From enrollment up to 12 months
From enrollment up to 12 months
Number of Infants Small for Gestational Age
Time Frame: From delivery up to 12 months after delivery
From delivery up to 12 months after delivery
Number of Cases of Intrauterine Growth Restriction (IUGR)
Time Frame: From enrollment up to 12 months
From enrollment up to 12 months
Number of Other Specific Pregnancy or Delivery Complications
Time Frame: From enrollment up to 12 months
From enrollment up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Vikki Brown, M.D., Syneos Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2009

Primary Completion (Actual)

April 13, 2017

Study Completion (Actual)

April 13, 2017

Study Registration Dates

First Submitted

January 30, 2009

First Submitted That Met QC Criteria

January 30, 2009

First Posted (Estimate)

February 2, 2009

Study Record Updates

Last Update Posted (Actual)

May 16, 2019

Last Update Submitted That Met QC Criteria

May 15, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H4621g

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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