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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Participants Developing Oligohydramnios
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Prior knowledge of pregnancy outcome (i.e., live birth, stillbirth, or abortion) at time of enrollment
研究组 & 干预措施
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.
干预措施: Trastuzumab (Drug)
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.
干预措施: Trastuzumab (Drug)
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.
干预措施: Pertuzumab (Drug)
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.
干预措施: Ado-Trastuzumab Emtansine (Drug)
结局指标
主要结局
Number of Participants Developing Oligohydramnios
时间窗: From enrollment up to the delivery or upon termination of pregnancy (up to 12 months)
Number of Fetal Deaths/Stillbirths
时间窗: From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months)
Number of Live Births
时间窗: From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months)
Number of Fetal or Infant Deformations
时间窗: From delivery up to 12 months after delivery
Number of Fetal or Infant Major Malformations
时间窗: From delivery up to 12 months after delivery
Number of Fetal or Infant Functional Deficits
时间窗: From delivery up to 12 months after delivery
Number of Fetal or Infant Disruptions
时间窗: From delivery up to 12 months after delivery
次要结局
- 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)