Clinical trial NCT00833963: A Study of Pregnancy and Pregnancy Outcomes in Women With Breast Cancer Treated With Trastuzumab, Pertuzumab in Combination With Trastuzumab, or Ado-Trastuzumab Emtansine
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Pregnancy
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2009-02-02
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Developing Oligohydramnios
timeFrame: From enrollment up to the delivery or upon termination of pregnancy (up to 12 months)
measure: Number of Live Births
timeFrame: From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months)
measure: Number of Fetal Deaths/Stillbirths
timeFrame: From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months)
measure: Number of Fetal or Infant Major Malformations
timeFrame: From delivery up to 12 months after delivery
measure: Number of Fetal or Infant Deformations
timeFrame: From delivery up to 12 months after delivery
measure: Number of Fetal or Infant Disruptions
timeFrame: From delivery up to 12 months after delivery
measure: Number of Fetal or Infant Functional Deficits
timeFrame: From delivery up to 12 months after delivery
Secondary outcomes:
measure: Number of Spontaneous Abortions
timeFrame: From enrollment up to 12 months
measure: Number of Therapeutic Abortions, or Elective Abortions
timeFrame: From enrollment up to 12 months
measure: Number of Premature Births
timeFrame: From enrollment up to 12 months
measure: Number of Infants Small for Gestational Age
timeFrame: From delivery up to 12 months after delivery
measure: Number of Cases of Intrauterine Growth Restriction (IUGR)
timeFrame: From enrollment up to 12 months
measure: Number of Other Specific Pregnancy or Delivery Complications
timeFrame: From enrollment up to 12 months
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Kendle International, Inc
state: North Carolina
Study officials:
affiliation: Syneos Health
name: Vikki Brown, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.