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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)

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00833963
First received: January 30, 2009
Last updated: July 26, 2017
Last verified: July 2017
  Purpose
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).

Condition Intervention
Breast Cancer Pregnancy Drug: Trastuzumab Drug: Pertuzumab Drug: Ado-Trastuzumab Emtansine

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Number of Participants Developing Oligohydramnios [ Time Frame: From enrollment up to the delivery or upon termination of pregnancy (up to 12 months) ]
  • Number of Live Births [ Time Frame: From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months) ]
  • Number of Fetal Deaths/Stillbirths [ Time Frame: From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months) ]
  • Number of Fetal or Infant Major Malformations [ Time Frame: From delivery up to 12 months after delivery ]
  • Number of Fetal or Infant Deformations [ Time Frame: From delivery up to 12 months after delivery ]
  • Number of Fetal or Infant Disruptions [ Time Frame: From delivery up to 12 months after delivery ]
  • Number of Fetal or Infant Functional Deficits [ Time Frame: From delivery up to 12 months after delivery ]

Secondary Outcome Measures:
  • Number of Spontaneous Abortions [ Time Frame: From enrollment up to 12 months ]
  • Number of Therapeutic Abortions, or Elective Abortions [ Time Frame: From enrollment up to 12 months ]
  • Number of Premature Births [ Time Frame: From enrollment up to 12 months ]
  • Number of Infants Small for Gestational Age [ Time Frame: From delivery up to 12 months after delivery ]
  • Number of Cases of Intrauterine Growth Restriction (IUGR) [ Time Frame: From enrollment up to 12 months ]
  • Number of Other Specific Pregnancy or Delivery Complications [ Time Frame: From enrollment up to 12 months ]

Estimated Enrollment: 100
Actual Study Start Date: January 14, 2009
Estimated Study Completion Date: January 31, 2025
Estimated Primary Completion Date: January 31, 2025 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Drug: Trastuzumab
Participants will receive trastuzumab as determined by their treating physicians' standards of care.
Other Name: Herceptin
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.
Drug: Trastuzumab
Participants will receive trastuzumab as determined by their treating physicians' standards of care.
Other Name: Herceptin
Drug: Pertuzumab
Participants will receive pertuzumab as determined by their treating physicians' standards of care.
Other Name: Perjeta
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.
Drug: Ado-Trastuzumab Emtansine
Participants will receive ado-trastuzumab emtansine as determined by their treating physicians' standards of care.
Other Name: Kadcyla

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833963

Contacts
Contact: MotHER Registry Coordinating Center www.motherpregnancyregistry.com 800-690-6720

Locations
United States, North Carolina
Kendle International, Inc Recruiting
Wilmington, North Carolina, United States, 28405
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Vikki Brown, M.D. INC Research
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00833963     History of Changes
Other Study ID Numbers: H4621g
Study First Received: January 30, 2009
Last Updated: July 26, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pertuzumab
Ado-trastuzumab emtansine
Trastuzumab
Maytansine
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2017