Clinical trial · Observational
A Study of Pregnancy and Pregnancy Outcomes in Women With Breast Cancer Treated With Trastuzumab, Pertuzumab in Combination With Trastuzumab, or Ado-Trastuzumab Emtansine
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Pregnancy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ado-Trastuzumab Emtansine | Drug | Trastuzumab Emtansine | ALIAS |
| Pertuzumab | Drug | Pertuzumab | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- label
- 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.
- interventionNames
- Drug: Trastuzumab
- label
- 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.
- interventionNames
- Drug: Trastuzumab
- Drug: Pertuzumab
- label
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPerachino 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. PMID 35594464