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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab | Drug | Participants will receive trastuzumab as determined by their treating physicians' standards of care. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Vikki Brown, M.D. | Syneos Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kendle International, Inc | Wilmington | North Carolina | 28405 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35594464 | Derived | 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. |
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|
| Pertuzumab | Drug | Participants will receive pertuzumab as determined by their treating physicians' standards of care. |
|
|
| Ado-Trastuzumab Emtansine | Drug | Participants will receive ado-trastuzumab emtansine as determined by their treating physicians' standards of care. |
|
|
| 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 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| C485206 | pertuzumab |
| D000080044 | Ado-Trastuzumab Emtansine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D008453 | Maytansine |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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