Clinical trial · Interventional
Evaluation of Sequencing of Anthracyclines and Taxanes for Locally Advanced HER2-negative Breast Cancer
NEOSAMBA Clinical Trial - Stage I
NCT04540692CI-TRIAL-00125485NEOSAMBAactive not recruitingPhase 3ClinicalTrials.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)
Phase III randomized clinical trial evaluating the sequencing of anthracyclines and taxanes in neoadjuvant therapy for locally advanced HER2-negative breast cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide + Doxorrubicin | Drug | — | UNRESOLVED |
| Docetaxel or Paclitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Start with Cyclophosphamide + Doxorrubicin
- description
- Patients will receive the following treatment schedule: Doxorubicin 60mg/m²; Cyclophosphamide 600mg/m² intravenously every 21 days for 3 cycles, followed by docetaxel 75-100mg/m2 intravenously every 21 days for 4 cycles or weekly paclitaxel 80mg/m2 for 12 weeks.
- interventionNames
- Drug: Cyclophosphamide + Doxorrubicin
- type
- EXPERIMENTAL
- label
- Start with Docetaxel or Paclitaxel
- description
- Patients will receive the following treatment schedule: Docetaxel 75-100mg/m² intravenously every 21 days for 4 cycles or weekly paclitaxel 80mg/m² for 12 weeks, followed by Doxorubicin 60mg/m²; Cyclophosphamide 600mg/m² intravenously every 21 days, for 3 cycles.
- interventionNames
- Drug: Docetaxel or Paclitaxel
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female participants, with at least 18 years old on the day of signing the free and informed consent; * Invasive breast carcinoma stage III (RH positive) or IIB/III (RH negative), according to TNM 8th edition; Histologically confirmed diagnosis of invasive breast carcinoma (with any histology), HER-2 negative; * The participant (or legally acceptable representative, if applicable) provides written informed consent for the study; * The participant must agree to use a contraceptive as detailed in Appendix B of this protocol during the treatment period and for at least 120 days after the last dose of the study treatment; * Have a functional capacity according to the Eastern Cooperative Oncology Group (ECOG) from 0 to 2. The evaluation of the ECOG must be carried out within 7 days before the inclusion date. * Have adequate organic function. The samples must be collected within 60 days before the start of the study treatment; * Have adequate cardiac function as assessed by echocardiogram or MUGA performed up to 60 days before the start of treatment under study. Exclusion Criteria: \- Individuals who do not meet the inclusion criteria above-mentioned.
References
Publications (0)
Data not yet available
No reference posted for this study.