Clinical trial · Observational
Phenotype and Prognosis of Patients With Breast Cancer and Pathogenic Variants of TP53
Phenotype and Prognosis of Patients With Breast Cancer and Pathogenic Variants of TP53 (BREAST TP53)
- 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)
A prospective and retrospective cohort study of patients with a documented pathogenic or likely pathogenic variants of TP53 were identified using blood DNA colection and breast cancer diagnosis by histological confirmation, between 1999 and 2022. All patients were followed by the Hereditary Group of a single cancer center (Instituto do Cancer do Estado de Sao Paulo). Patients were included if they had a histopathological diagnosis of localized invasive carcinoma or in situ carcinoma of the breast and with localized disease. Patients met Revised Chompret criteria, Li Fraumeni like syndrome,family member of carrier TP53 or hereditary breast and ovarian syndrome for germline test.
Conditions
Conditions (4)
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 |
| Li-Fraumeni Syndrome | — | UNRESOLVED | — |
| Prognosis Breast Cancer | — | UNRESOLVED | — |
| TP53 R337H | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention in this study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Breast Cancer and documented pathogenic variant TP53
- description
- Documented pathogenic or likely pathogenic variants of TP53 were identified using blood DNA colection and localized breast cancer diagnosis by histological confirmation. All patients met Revised Chompret criteria or Li Fraumeni like syndrome or family member of carrier TP53
- interventionNames
- Other: No intervention in this study
- label
- Breast Cancer and no documented pathogenic variants in genetic test
- description
- Control group with localized breast cancer and no pathogenic variants documented in a genetic test
- interventionNames
- Other: No intervention in this study
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- We proposed 45 cases TP53 pathogenic carriers and breast cancer diagnosed for each case included we will be selected 2 controls resulting in 90 control patients, for control are estimated with the same age (range 10 years)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Breast cancer (histopathological diagnosis of localized invasive carcinoma or in situ carcinoma of the breast) and documented germline pathogenic variants of TP53.
Exclusion Criteria:
* Patients with only other types of breast cancer such as sarcoma and phyllodes tumor were excluded from the analysis.
* Metastatic Breast Cancer at diagnosis ("denovo")References
Publications (0)
Data not yet available