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
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
1 other identifier
observational
20
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 14, 2009
CompletedFirst Submitted
Initial submission to the registry
January 30, 2009
CompletedFirst Posted
Study publicly available on registry
February 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 13, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 13, 2017
CompletedMay 16, 2019
May 1, 2019
8.2 years
January 30, 2009
May 15, 2019
Conditions
Outcome Measures
Primary Outcomes (7)
Number of Participants Developing Oligohydramnios
From enrollment up 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 Deaths/Stillbirths
From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months)
Number of Fetal or Infant Major Malformations
From delivery up to 12 months after delivery
Number of Fetal or Infant Deformations
From delivery up to 12 months after delivery
Number of Fetal or Infant Disruptions
From delivery up to 12 months after delivery
Number of Fetal or Infant Functional Deficits
From delivery up to 12 months after delivery
Secondary Outcomes (6)
Number of Spontaneous Abortions
From enrollment up to 12 months
Number of Therapeutic Abortions, or Elective 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 Cases of Intrauterine Growth Restriction (IUGR)
From enrollment up to 12 months
- +1 more secondary outcomes
Study Arms (3)
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.
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.
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.
Interventions
Participants will receive trastuzumab as determined by their treating physicians' standards of care.
Participants will receive pertuzumab as determined by their treating physicians' standards of care.
Participants will receive ado-trastuzumab emtansine as determined by their treating physicians' standards of care.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Prior knowledge of pregnancy outcome (i.e., live birth, stillbirth, or abortion) at time of enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (1)
Kendle International, Inc
Wilmington, North Carolina, 28405, United States
Related Publications (1)
Perachino M, Poggio F, Arecco L, Blondeaux E, Spinaci S, Marrocco C, Levaggi A, Lambertini M. Update on Pregnancy Following Breast Cancer Diagnosis and Treatment. Cancer J. 2022 May-Jun 01;28(3):176-182. doi: 10.1097/PPO.0000000000000599.
PMID: 35594464DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Vikki Brown, M.D.
Syneos Health
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2009
First Posted
February 2, 2009
Study Start
January 14, 2009
Primary Completion
April 13, 2017
Study Completion
April 13, 2017
Last Updated
May 16, 2019
Record last verified: 2019-05