Clinical trial · Interventional
Tailored Neoadjuvant Chemotherapy for Stage II/III Breast Cancer With Tumor Size More Than 2 cm
A Randomized Phase III Study of Docetaxel/ Epirubicin Versus Tailored Regimens as Neoadjuvant Chemotherapy for Stage II/III Breast Cancer With Tumor Size More Than 2 cm
NCT00776724CI-TRIAL-00038466TaiNACcompletedPhase 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)
This is a multi-center randomized phase III trial. The purpose is to evaluate and compare the pathological complete response (pCR) rates after neoadjuvant chemotherapy with tailored chemotherapeutic regimens or standard chemotherapy for stage II/III breast cancer with tumor size more than 2 cm.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| E-HDFL,EP,TE,N-HDFL,NP,T-HDFL,TP | Drug | — | UNRESOLVED |
| Taxotere , Epirubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- docetaxel-epirubicin for 4 cycles before surgery
- interventionNames
- Drug: Taxotere , Epirubicin
- type
- EXPERIMENTAL
- label
- 2
- description
- Tailored regimens, base on immunohistochemical study of the tumor biopsy tissue, for 4 cycles before surgery.
- interventionNames
- Drug: E-HDFL,EP,TE,N-HDFL,NP,T-HDFL,TP
Primary outcomes (1)
- measure
- To evaluate and compare the pathological complete response (pCR) rates
- timeFrame
- operation after 4 cycles of neoadjuvant chemotherapy with tailored chemotherapeutic regimens or TE
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed invasive, but non-inflammatory, breast carcinoma, with stage II or III disease (AJCC 7th ed) * And, tumor size more than 2 cm in greatest diameter measured by estimated by CT scan or MRI * Documented Her2/neu negative , including score 0, 1+, or 2+ by immunohistochemistry * No prior radiotherapy, hormonal therapy or chemotherapy for invasive breast cancer * Performance status of ECOG 0, 1, * Female with age older than 20 years * Laboratory parameter * Absolute neutrophil count (ANC) ≧1500/mm3 * Total bilirubin ≦2.0 times the upper limit of normal (ULM) * AST or ALT ≦2.5 times the upper limit of normal (ULM) * Platelets ≧100,000/mm3 * Serum creatinine ≦1.5 x ULM * Fasting triglyceride ≧ 70 mg/dL * Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * Evidence of metastatic breast cancer or inflammatory breast cancer * Bilateral breast cancer, metaplastic carcinoma, or mucinous carcinoma * Known allergy to any of the study drugs or to agents containing Cremophor. * Serious intercurrent infections or medical illnesses that are uncontrolled or the control of which may be jeopardized by this therapy * Psychiatric disorders or other conditions regarding the subject incapable of complying with the requirements of the protocol * Evidence of baseline sensory or motor neuropathy * Pregnant or breast feeding women * Previous or current systemic malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ with a disease-free interval of at least 5 years
References
Publications (0)
Data not yet available
No reference posted for this study.