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 Clinical Trial

— MotHER  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833963
• Other study ID #: H4621g
• Status: Completed
• Start date: January 14, 2009
• Est. completion date: April 13, 2017

Study information

• Verified date: May 2019
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 13, 2017
• Est. primary completion date: April 13, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Pregnancy

Intervention

Drug:
• Trastuzumab
Participants will receive trastuzumab as determined by their treating physicians' standards of care.
• Pertuzumab
Participants will receive pertuzumab as determined by their treating physicians' standards of care.
• Ado-Trastuzumab Emtansine
Participants will receive ado-trastuzumab emtansine as determined by their treating physicians' standards of care.

Locations

Country	Name	City	State
United States	Kendle International, Inc	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Developing Oligohydramnios		From enrollment up to the delivery or upon termination of pregnancy (up to 12 months)
Primary	Number of Live Births		From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months)
Primary	Number of Fetal Deaths/Stillbirths		From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months)
Primary	Number of Fetal or Infant Major Malformations		From delivery up to 12 months after delivery
Primary	Number of Fetal or Infant Deformations		From delivery up to 12 months after delivery
Primary	Number of Fetal or Infant Disruptions		From delivery up to 12 months after delivery
Primary	Number of Fetal or Infant Functional Deficits		From delivery up to 12 months after delivery
Secondary	Number of Spontaneous Abortions		From enrollment up to 12 months
Secondary	Number of Therapeutic Abortions, or Elective Abortions		From enrollment up to 12 months
Secondary	Number of Premature Births		From enrollment up to 12 months
Secondary	Number of Infants Small for Gestational Age		From delivery up to 12 months after delivery
Secondary	Number of Cases of Intrauterine Growth Restriction (IUGR)		From enrollment up to 12 months
Secondary	Number of Other Specific Pregnancy or Delivery Complications		From enrollment up to 12 months