Clinical trial · Observational
Triple-negative Breast Cancer: a New Perspective on Biomarkers
Triple-negative Breast Cancer: a New Perspective on Predictive and Prognostic Biomarkers
NCT03539965CI-TRIAL-00033144TNBCbrazilcompletedClinicalTrials.gov clinicaltrialsProvenance
- 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 single-institutional cohort to determine the prevalence of new immunohistochemical panel in advanced triple-negative submitted to neoadjuvant chemotherapy and its association with response and survival.
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 |
|---|---|---|---|
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
| Triple Negative Breast Neoplasms | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Single-arm cohort
- description
- Initially, patients will be analyzed in a single group. After determining the status of the biomarkers, the patient sample will be divided into specific groups for comparative purposes.
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- Approximately 24 months: from diagnosis up to the first event defined as local recurrence or distant relapse, or death, whichever come first through study completion.
- description
- The first event defined as local recurrence or distant relapse, or death, whichever come first.
Secondary outcomes (4)
- measure
- Clinical Response Rate
- timeFrame
- From date of first cycle of chemotherapy until completion of neoadjuvant treatment, approximately 16 weeks
- description
- To determine the clinical response rate in patients with palpable disease.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Women older than 18 years * Locally advanced TNBC (T3-4, any Node, M0; any Tumor, N1-3, M0) * Patients submitted to anthracycline and taxane-based neoadjuvant chemotherapy and then operated between January 2010 and December 2014 at the Brazilian National Cancer Institute. Exclusion Criteria: * Patients with metastatic Breast Cancer; * Other non-epithelial histologies of breast cancer; * Pure Ductal Carcinoma In Situ diagnoses are not eligible. * Patients with scarce material for immunohistochemistry; * Other primary synchronous or anachronistic tumors in the breast or other sites; * No prior immunotherapeutic, chemotherapeutic or antiandrogenic drugs allowed * Patients treated with alternative neoadjuvant chemotherapy regimens (not based on anthracycline and taxane) or with only hormone therapy; * Patients who received chemotherapy or who were operated outside the INCA.
References
Publications (0)
Data not yet available
No reference posted for this study.