Breast Cancer Clinical Trial
— BRCAPREOfficial title:
Observational Study of Breast Cancer Diagnosed During Pregnancy
| NCT number | NCT02102282 |
| Other study ID # | PR(AMI)83/2012 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | March 29, 2014 |
| Last updated | April 1, 2014 |
| Start date | October 2012 |
Patients are managed clinically according to ad hoc standards and scientific knowledge by a multidisciplinary team. Clinical decisions are made after a patient physician discussion. Blood and tissue samples are collected. Diagnostic, obstetric management surgical treatment, systemic treatment, perinatal results and follow up data are collected.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | |
| Est. primary completion date | December 2022 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - Patients with breast cancer diagnosed during pregnancy Exclusion Criteria: - Patients who refuse informed consent |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Vall d'Hebron | Barcelona | |
| Spain | Hospital Vall d'Hebron | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Universitari Vall d'Hebron Research Institute |
Spain,
Córdoba O, Llurba E, Cortés J, Sabadell MD, Lirola JL, Ferrer Q, Xercavins J. Complete pathological remission in a patient with hormone-receptor positive and c-erbB-2 expression-negative breast cancer treated with FAC chemotherapy during pregnancy. Tumori — View Citation
Córdoba O, Llurba E, Saura C, Rubio I, Ferrer Q, Cortés J, Xercavins J. Multidisciplinary approach to breast cancer diagnosed during pregnancy: maternal and neonatal outcomes. Breast. 2013 Aug;22(4):515-9. doi: 10.1016/j.breast.2012.10.005. Epub 2012 Oct — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Perinatal results | Gestational age, weight, Apgar, blood tests | Delivery | Yes |
| Secondary | Maternal outcome | Over all survival, disease free survival | 5 year and 10 year | Yes |
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