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)

Genentech

Status: Completed

Conditions: Breast Cancer; Pregnancy

Treatments: Drug: Pertuzumab; Drug: Trastuzumab; Drug: Ado-Trastuzumab Emtansine

Study type: Observational

Funder types: Industry

Identifiers

NCT00833963

H4621g

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 3 patient groups

Participants Treated With Trastuzumab

Description:

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.

Treatment:

Drug: Trastuzumab

Participants Treated With Trastuzumab and Pertuzumab

Description:

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.

Treatment:

Drug: Pertuzumab

Drug: Trastuzumab

Participants Treated With Ado-Trastuzumab Emtansine

Description:

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.

Treatment:

Drug: Ado-Trastuzumab Emtansine