Clinical trial · Interventional
Primary Chemotherapy With Adriamycin/Cyclophosphamide(AC) vs Taxotere/Xeloda(TX) for Stage II and III Breast Cancer
A Phase III Randomized Study of Primary Chemotherapy With Adriamycin/Cyclophosphamide(AC) vs Taxotere/Xeloda(TX) for Stage II and III Breast Cancer
NCT00352378CI-TRIAL-00005092completedPhase 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 an open labeled phase III randomized trial. The patients with clinical stage II and III will undergo mammotome biopsy of breast tumor for histologic diagnosis, immunohistochemical studies for estrogen receptor(ER), progesterone receptor(PR), HER-2/neu and others. PET results will determine the positivity of lymph node metastasis.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anthracycline, Cyclophosphamide, Docetaxel, Capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Adriamycin plus Cyclophosphamide
- description
- Intravenous infusion of Adriamycin 60mg/m2 , over 30 min, onD1 and Intravenous infusion of cyclophosphamide 600 mg/m2 over 30 min on D1.
- interventionNames
- Drug: Anthracycline, Cyclophosphamide, Docetaxel, Capecitabine
- type
- EXPERIMENTAL
- label
- Taxotere plus Xeloda
- description
- Intravenous infusion of Taxotere 75 mg/m2 over 1 hr, on D1, and Xeloda 1000mg/m2.p.o. BID x 14days on D1-D14
- interventionNames
- Drug: Anthracycline, Cyclophosphamide, Docetaxel, Capecitabine
Primary outcomes (1)
- measure
- pathologic complete remission
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients must have histologically confirmed and newly diagnosed breast cancer: stage II and III breast cancer. * PET results will determine node positivity. * No prior hormonal , chemotherapy or radiotherapy is allowed. * No breast operation other than biopsy to make diagnosis is allowed. * Age:18-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1) * Adequate hematopoietic function: 1. Absolute granulocyte count \>=1500/mm3, 2. platelet \>=100,000/mm3, Hemoglobin \>=10 g/mm3 * Adequate renal function: Serum creatinine \<=1.5 mg/dl * Adequate hepatic function: 1. total bilirubin: \<=1.5 mg/dl 2. AST/ALT: \<=three times normal 3. Alkaline phosphatase: \<=three times normal * Adequate cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment Exclusion Criteria: * Patients who received hormonal , chemotherapy or radiotherapy for breast cancer * Patients who underwent surgery for breast cancer * Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer
References
Publications (0)
Data not yet available
No reference posted for this study.