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

Completed

• Conditions: Breast Cancer; Pregnancy
• Interventions: Drug: Trastuzumab; Drug: Ado-Trastuzumab Emtansine; Drug: Pertuzumab

• Registration Number: NCT00833963
• Lead Sponsor: Genentech, Inc.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-14
• Study First Submitted: 2009-01-30
• Study First Submitted QC: 2009-01-30
• Study First Posted: 2009-02-02
• Primary Completion: 2017-04-13
• Study Completion: 2017-04-13
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-15
• Last Update Posted: 2019-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants Treated With Trastuzumab	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.
Participants Treated With Trastuzumab and Pertuzumab	Trastuzumab	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.
Participants Treated With Ado-Trastuzumab Emtansine	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.
Participants Treated With Trastuzumab and Pertuzumab	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Developing Oligohydramnios	From enrollment up to the delivery or upon termination of pregnancy (up to 12 months)
Number of Fetal Deaths/Stillbirths	From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months)
Number of Live Births	From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months)
Number of Fetal or Infant Deformations	From delivery up to 12 months after delivery
Number of Fetal or Infant Major Malformations	From delivery up to 12 months after delivery
Number of Fetal or Infant Functional Deficits	From delivery up to 12 months after delivery
Number of Fetal or Infant Disruptions	From delivery up to 12 months after delivery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kendle International, Inc; 🇺🇸 Wilmington, North Carolina, United States