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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Breast Cancer, Pregnancy

Intervention / Treatment
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* Drug: Trastuzumab
* Drug: Pertuzumab
* Drug: Ado-Trastuzumab Emtansine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants Treated With Trastuzumab<br>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<br>* Participants will receive trastuzumab as determined by their treating physicians' standards of care.<br>* Other names: Herceptin;|
| Participants Treated With Trastuzumab and Pertuzumab<br>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<br>* Participants will receive trastuzumab as determined by their treating physicians' standards of care.<br>* Other names: Herceptin;Drug: Pertuzumab<br>* Participants will receive pertuzumab as determined by their treating physicians' standards of care.<br>* Other names: Perjeta;|
| Participants Treated With Ado-Trastuzumab Emtansine<br>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<br>* Participants will receive ado-trastuzumab emtansine as determined by their treating physicians' standards of care.<br>* Other names: Kadcyla;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of Other Specific Pregnancy or Delivery Complications |  | From enrollment up to 12 months |