Clinical trial · Interventional
NeoSAMBA: Neoadjuvant: Does the Sequence of Anthracycline and Taxane Matters: Before or After?
Randomized Phase II Trial of the Sequences of Anthracyline and Taxane in Locally Advanced Breast Cancer
NCT01270373CI-TRIAL-00043457NeoSAMBAunknownPhase 2ClinicalTrials.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)
The purpose of this study is to evaluate the usual and the reverse sequence of an anthracycline followed by a taxane in locally advanced 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 |
|---|---|---|---|
| Docetaxel x 3 followed by FAC x 3 | Drug | — | UNRESOLVED |
| FAC x 3 followed by Docetaxel x 3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- FAC x 3 followed by Docetaxel x 3
- interventionNames
- Drug: FAC x 3 followed by Docetaxel x 3
- type
- EXPERIMENTAL
- label
- Docetaxel x 3 followed by FAC x 3
- interventionNames
- Drug: Docetaxel x 3 followed by FAC x 3
Primary outcomes (1)
- measure
- Pathological complete response
- timeFrame
- 6 months
Secondary outcomes (1)
- measure
- Cardiac toxicity
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: 1. Stage IIB to IIIB HER-2 negative breast cancer 2. ECOG performance status ≤ 2 3. Neuropathy grade \<1 by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0) 4. Adequate hematologic function with: * Absolute neutrophil count (ANC) \>1500/μL * Platelets ≥100,000/μL * Hemoglobin ≥ 9 g/dL 5. Adequate hepatic and renal function with: * Serum bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x institutional ULN * Alkaline phosphatase ≤2.5 x institutional ULN * Serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥ 50 mL/min 6. Adequate cardiac function * Left ventricular ejection fraction (LVEF) within institutional normal range 7. Knowledge of the investigational nature of the study and ability to provide consent for study participation Exclusion criteria 1. Pregnancy 2. Bilateral, synchronous breast cancer 3. Previous diagnosis of breast or other cancer 4. Any other disease(s), psychiatric condition, metabolic dysfunction, that contraindicates the use of study drugs or that would make the patient inappropriate for this study
References
Publications (1)
- DERIVEDBines J, Small IA, Sarmento R, Kestelman F, Silva S, Rodrigues FR, Faroni L, Goncalves A, Ebecken E, Maroun P, Millen E, Bonamino M. Does the Sequence of Anthracycline and Taxane Matter? The NeoSAMBA Trial. Oncologist. 2020 Sep;25(9):758-764. doi: 10.1634/theoncologist.2019-0805. Epub 2020 Jun 23. PMID 32476183